Introduction to Randomized Phase

Two small randomized phase II trials on synchronous disease showed an improvement in progression free survival, with the addition of LAT, and one also demonstrated an overall survival benefit.

The randomized phase 2 NCTN trial E1411 tested if progression-free survival (PFS) is prolonged by addition of bortezomib (V) (1.

We implemented an automated search strategy with weekly updates to identify randomized phase 2 and 3 clinical trials.

Design, Setting, and Participants This trial was a randomized phase 3 clinical trial conducted by the Children's Oncology Group at 155 hospitals in the US, Canada, Australia, and New Zealand with enrollment from December 2014 to September 2019 and follow-up until September 30, 2020.

MATERIALS/METHODS The SAKK 09/10 trial (NCT01272050) is an open-label, multicenter, randomized phase 3 trial performed in 24 centers in Switzerland, Germany, and Belgium.

Methods: We conducted an open-label multicenter randomized phase III trial (ClinicalTrials.

Patients and Methods BRAF V600E/K mutation status was determined on archived tissue and pretreatment stored plasma from 149 patients with unresectable stage IV melanoma who were enrolled between May 5, 2010 and May 2, 2014 in the North Central Cancer Treatment Group/Alliance N0879 randomized phase 2 clinical trial.

This randomized phase 2 clinical trial compares the effectiveness of MWA and RFA in medium-sized liver tumors.

Background To report our findings on quality of life (QoL) in a randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel (q3w nab-PTX) in patients with metastatic breast cancer (MBC).

To report our findings on quality of life (QoL) in a randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel (q3w nab-PTX) in patients with metastatic breast cancer (MBC).

MATERIALS AND METHODS This randomized phase II study enrolled patients with completely resected stage IA-IIIB EGFR-mutant non-small-cell lung cancer (American Joint Committee on Cancer 7th edition) after stage-appropriate standard-of-care adjuvant therapy.

Here, we describe the rationale and design for CANOPY-N, a randomized Phase II trial evaluating IL-1β inhibition with or without immune checkpoint inhibition as neoadjuvant treatment in patients with non-small-cell lung cancer.

To evaluate the clinical efficacy of continuing cetuximab vs bevacizumab plus chemotherapy crossover after first progression to cetuximab regimen in wild-type KRAS, NRAS and BRAF V600E mCRC, we conducted this prospective, open-label and randomized phase 2 trial in three cancer centers from Oct 1, 2016 to July 1, 2020.

gov, NCT03840239), a prospective, open label, multicenter, randomized phase 2 study, is underway.

OBJECTIVE The randomized phase 3 CORAIL trial evaluated whether lurbinectedin improved progression-free survival (PFS) compared to pegylated liposomal doxorubicin (PLD) or topotecan in patients with platinum-resistant ovarian cancer.

9011 Background: Lorlatinib, a third-generation ALK tyrosine kinase inhibitor, significantly improved progression-free survival (PFS) and overall/intracranial responses vs crizotinib in patients (pts) with previously untreated ALK-positive advanced non-small cell lung cancer (NSCLC) in the ongoing randomized Phase 3 CROWN study (NCT03052608).

In the international randomized phase III RATIFY trial, the multi-kinase inhibitor midostaurin significantly improved overall and event-free survival in patients 18-59 years of age with FLT3-mutated acute myeloid leukemia (AML).

Methods/DesignThis is a randomized phase III trial with measurable residual disease (MRD) after induction therapy and event-free survival (EFS) as primary endpoints.

Background: The C-TASK-FORCE phase I/II and Danish randomized phase II trials reported the promising efficacy of trifluridine/tipiracil (TAS102) plus bevacizumab (BEV) in patients with chemorefractory metastatic colorectal cancer (mCRC).

3552 Background: Prognostic biomarkers beside RAS/BRAF status are necessary to identify metastatic colorectal cancer (mCRC) patients who benefit from combined (COMB) versus sequential (SEQ) treatment with fluoropyrimidine, bevacizumab and irinotecan (randomized phase III XELAVIRI trial).

PURPOSE A Benchmark Case (BC) was performed as part of the quality assurance process of the randomized phase 2 GORTEC 2014-14 OMET study, testing the possibility of multisite stereotactic radiation therapy (SBRT) alone in oligometastatic head and neck squamous cell carcinoma (HNSCC) as an alternative to systemic treatment and SBRT.

The Javelin Head Neck 100 study is the first of several randomized phase III trials to test the addition of an anti-PD1/PD-L1 antibody to chemoradiotherapy (CRT) for locally advanced head and neck squamous cell carcinomas (HNSCC) [1].

Conclusions: This randomized phase 3 study proved that HAIC-FO had superior efficacy and survival outcome than sorafenib in the first-line treatment of primary diagnostic, advanced HCC, indicating that patients with heavy intrahepatic tumor burden, HAIC-FO monotherapy might be a better strategy than sorafenib.

Methods: Open-label, single center, phase Ib/randomized phase II trial, evaluating the safety and efficacy of the combination of M-PHP with ipilimumab (anti-CTLA-4 antibody) and nivolumab (anti-PD-1 antibody) in patients with unresectable hepatic metastases of UM in first line treatment, with or without limited extrahepatic disease.

Therefore, we conducted a randomized phase 2/3 study to determine whether FTD/TPI plus BEV is non-inferior to either FOLFIRI or S-1 and irinotecan plus BEV in terms of overall survival (OS) as second-line treatment in patients with mCRC.

Pembrolizumab, an anti-PD-1 antibody, demonstrated better OS respective to chemotherapy in a randomized phase 3 study for second-line treatment of mUC.

In the randomized phase 2 study (DESTINY-Gastric01) for HER2-positive advanced gastric or gastroesophageal junction cancer (AGC), patients treated with T-DXd showed a significantly higher response rate compared with the chemotherapy of physician’s choice, associated with remarkably prolonged progression-free and overall survival.

For patients with progressive radioactive iodine-refractory differentiated thyroid cancer (RR-DTC), multi-kinase inhibitors (MKIs) including sorafenib and lenvatinib prolonged progression-free survival compared with placebo in pivotal randomized phase 3 trials, although the benefit in overall survival has not been clearly confirmed, possibly because the patients who received placebo were permitted to cross-over to lenvatinib upon disease progression.

Several randomized phase III clinical trials have demonstrated significant clinical benefits—including significantly better overall survival and quality of life—for treatments that combine androgen-deprivation therapy with docetaxel, abiraterone acetate, enzalutamide, apalutamide, and/or radiotherapy to the primary tumour.

Additionally, a randomized phase II trial showed that metastasis-directed therapy for oligo-recurrent prostate cancer improved androgen-deprivation therapy (ADT)-free survival.

Patients and Methods: This randomized phase II trial included 188 patients with human epidermal growth factor receptor 2 (HER2)-negative BC treated with anthracycline followed by paclitaxel as NAC.

Background Randomized phase III trials have established the efficacy of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors as first-line treatment for EGFR mutation-positive advanced non–small-cell lung cancer (EGFR Mut+ NSCLC).

We conducted a multicenter, single-blind, placebo-controlled, randomized phase I/II clinical trial evaluating the safety and efficacy of FIT039 against verruca vulgaris.

Methods: This is a multicenter, double-blind, placebo-controlled, randomized phase 3 study in patients in partial (PR) or complete remission (CR) after completing at least 12 weeks of taxane-platinum combination therapy for primary Stage IV disease and recurrent disease (i.

3 months for sorafenib) in a global open-label randomized phase III study and was approved as the new first-line for advanced-stage HCC.

3559 Background: The MORPHEUS platform consists of multiple, global, open-label, randomized Phase Ib/II trials designed to identify early efficacy and safety signals of treatment (tx) combinations across cancers.

h 2 ( In The Lancet Regional Health – Western Pacific Dr Yu and olleagues present the results of the randomized phase 3 nonnferiority MASTER trial, evaluating an anthracycline-free regimen omprising 6 cycles of 3-weekly docetaxel (75mg/m 2 ) and cylophosphamide (600mg/m 2 ; TC 6 ) compared to two sequential nthracycline-taxane regimens, in women with clinically high risk, ER2 negative early breast cancer, defined by pT1-3 with involved ymph nodes, or T2-3N0 with at least one additional risk factor Grade 2-3, lymphovascular invasion, age ≤ 35, ER/PgR negative) 1].

Integrated immuno-genomic analyses in early breast cancer: Results from the Scandinavian breast group 2004-1 (SBG-2004-1) randomized phase II trial [abstract].

GOYA was a randomized phase 3 study comparing obinutuzumab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) vs standard-of-care rituximab plus CHOP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

Our findings provide a strong rationale for a randomized phase 3 study comparing neoadjuvant ipilimumab plus nivolumab versus standard adjuvant therapy with antibodies against the programmed cell death protein-1 (anti-PD-1) in macroscopic stage III melanoma.

3513 Background: Encorafenib + binimetinib + cetuximab (enco/bini/cetux; triplet) and enco + cetux (doublet) regimens improved overall survival and objective response rate vs standard of care in pts with previously treated BRAF V600E-mutant mCRC in the randomized phase 3 BEACON study.

Furthermore, the randomized phase 3 trial of ipilimumab-nivolumab versus platinum-pemetrexed chemotherapy demonstrated improved overall survival favouring ipilimumab-nivolumab (HR 0.

INTRODUCTION The previous randomized phase 3 trial (SELECT BC) showed that S-1 as a first-line chemotherapy for metastatic breast cancer (MBC) is non-inferior to taxane with respect to overall survival.

Recently, the clinical benefits of the FGFR2-IIIb-selective monoclonal antibody bemarituzumab for FGFR2b-positive GC patients were shown in a randomized phase II FIGHT trial of bemarituzumab combined with the first-line chemotherapy.

More recently, the approval of anti-FGFR (Fibroblast Growth Factor Receptor) and anti-nectin-4 inhibitors based on phase 2 studies in refractory disease, and the preliminary results of 3 randomized phase 3 trials combining chemotherapy and immunotherapy in first-line as well as using maintenance immunotherapy after chemotherapy induction, created a new paradigm in the treatment of metastatic disease.

Methods: The Triple-B study is a multicenter, randomized phase IIb trial that aims to prospectively validate predictive biomarkers, including baseline plasma vascular endothelial growth factor receptor-2 (pVEGFR-2), for bevacizumab benefit.

reported the results of a multinational, randomized phase 2 study (Pre-MENAC study, feasibility study) of multimodal intervention in patients with advanced non-small-cell lung cancer (NSCLC) and pancreatic cancer.

METHODS This study were analyzed using the data of two randomized phase III trials (JCOG0207 and JCOG0803/WJOG4307L) for elderly patients with advanced non-small cell lung cancer and included all eligible patients who were assessed before treatment with four geriatric assessment tools: the Barthel activities of daily living index, Lawton instrumental activities of daily living scale, Mini-Mental State Examination, and Geriatric Depression Scale-15.

Methods: We utilized plasma samples from NANT11-01 (NCT02035137), a multi-center, open label, randomized phase II clinical trial evaluating MIBG with or without radiation sensitizers for patients with relapsed or refractory neuroblastoma.

A patient-reported outcome (PRO) is a measurement of the patient’s condition, reported directly by the patient, without the interpretation by a clinician or anyone else [1] Recently, there has been a growing interest in the integration of PROs as part of data collection about toxicity and symptoms experienced by patients with cancer This integration could have relevant implications not only for a more accurate reporting of adverse events and definition of quality of life (QoL) within clinical trials [2], but also for a better patients’ management in routine clinical practice [3] Many tools and questionnaires have been validated to properly measure QoL and symptoms in patients with lung cancer The inclusion of these measures in clinical trials has several important advantages It allows providing a patient-focused assessment of the burden and the impact of disease Moreover, it allows completely assessing the clinical benefit of a therapy, by complementing the information provided by commonly used efficacy endpoints, including overall survival, and the traditional description of safety based on physicians’ assessment Furthermore, the availability of QoL data from trials could allow a more accurate patient-physician communication about the treatment strategies offered in clinical practice However, a systematic review that we performed in order to evaluate the adoption of QoL among endpoints in randomized phase III trials conducted in lung cancer, published between 2012 and 2018 in 11 major journals, showed quite disappointing findings [4] Beyond the importance in clinical trials, PROs can play an important role in clinical practice Several studies have demonstrated a clear benefit in terms of patients’ QoL [5,6] Our experience, focused on the adoption of PROs in patients receiving active anticancer treatment at Mauriziano Hospital in Turin, showed that the introduction of PROs, thanks to an active role of nurses, was feasible, produced high patients’ satisfaction and a significant QoL improvement compared to the traditional modality of visit [6] In details, we compared 2 groups: patients in the control group underwent “usual” visits, while patients in the “PRO” group received a paper questionnaire by a dedicated nurse before each visit, in order to provide information about symptoms and toxicities After 1 month, mean change from baseline of global QoL was significantly better in the PRO group, and significantly higher proportion of patients obtained a clinically significant improvement in global QoL score In addition to QoL benefit, several studies have shown a significant improvement in overall survival with the adoption of electronic PROs in patients with lung cancer [7-9] In a pivotal randomized trial involving US patients with different solid tumors (including lung cancer) undergoing chemotherapy, patients assigned to the control arm received usual care, while subjects assigned to experimental arm could report their symptoms remotely from home, using tablet computers or computer kiosks [5,7] Doctors received a report of symptoms referred by patients during visits, and nurses received email alerts when patients reported severe or worsening symptoms Beyond the QoL improvement (the primary endpoint of the trial), a significantly longer life expectancy in the experimental arm (median 31 2 months) compared to the usual care arm (26 0 months) was reported [7] A French randomized trial, conducted in lung cancer patients without evidence of disease progression after or during initial treatment, compared a web-mediated follow-up algorithm (experimental arm), based on weekly self-scored patient symptoms, with routine follow-up with CT scans scheduled every 3-6 months according to the disease stage (control arm) [8] In the experimental arm, the oncologist received automatically an alert email when self-scored symptoms matched predefined criteria Notably, a significant improvement in overall survival was found in patients assigned to experimental arm [9] The adoption of electronic PROs in clinical practice could have many advantages [10] Regular discussion of PROs questionnaires, filled out electronically by patients and received by nurses or doctors, could allow a systematic check of the clinical trend of symptoms and side-effects The early, proactive identification of worsening symptoms and toxicities could help prevent the occurrence of severe adverse events needing ER access and hospitalization Adoption and discussion of PROs would reasonably have a positive psychological impact on patients, increasing their satisfaction with healthcare services While the adoption of electronic PROs could initially appear as a challenging organizational effort, we believe that their benefits will definitely be evident in the long-term The use of PROs may allow a significant benefit in terms of patients’ QoL, and this should be more than enough to consider its adoption in clinical practice, which - overall survival benefit or not – is worth the trouble References: 1 Di Maio M, et al Patient-reported outcomes in the evaluation of toxicity of anticancer treatments Nat Rev Clin Oncol 2016;13(5):319-25 2 Marandino L, et al Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016 Ann Oncol 2018;29:2288-2295 3 Sperti E, Di Maio M Outcomes research: Integrating PROs into the clinic - overall survival benefit or not, it's worth the trouble Nat Rev Clin Oncol 2017;14(9):529-530 4 Reale ML, et al Quality of life analysis in lung cancer: A systematic review of phase III trials published between 2012 and 2018 Lung Cancer 2020 Jan;139:47-54 5 Basch E, et al Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial J Clin Oncol 2016;34(6):557-65 6 Baratelli C, et al The role of patient-reported outcomes in outpatients receiving active anti-cancer treatment: impact on patients' quality of life Support Care Cancer 2019;27(12):4697-4704 7 Basch E, et al Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment JAMA 2017;318(2):197-198 8 Denis F, et al Randomized Trial Comparing a Web-Mediated Follow-up With Routine Surveillance in Lung Cancer Patients J Natl Cancer Inst 2017 Sep 1;109(9) 9 Denis F, et al Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer JAMA 2019;321(3):306-307 10 Marandino L, et al COVID-19 Emergency and the Need to Speed Up the Adoption of Electronic Patient-Reported Outcomes in Cancer Clinical Practice JCO Oncol Pract 2020;16(6):295-298 Keywords: patient-reported outcomes, health-related quality of life, ePROs.

We are conducting an open-label, parallel, randomized phase 2 trial to investigate the effect on preventing or alleviating cancer cachexia and safety of a multi-modal intervention including anti-inflammation, omega-3-fatty acids, nutritional supplement with counselling, physical exercise, psychiatric intervention as well as bojungikki-tang, which mediates immune-modulation and reverse inflammation-related chronic consumptive wasting condition as a complementary and alternative medicine compared to patients receiving best supportive care.

Background: The purpose of this trial is to evaluate the success rate of salvage radiation therapy (SRT) for recurrence of prostate cancer (PCa) after radical prostatectomy with and without planning based on prostate specific membrane antigen (PSMA) positron emission tomography (PET) Methods: This is a multicenter, prospective, randomized, controlled, open-label, Phase 3 clinical imaging trial powered for clinical outcome at 5 years UCLA is the leading central site in which PSMA PET, clinical follow-up and data management are being done UCSF was a participating site in which PSMA PET imaging can be done SRT can be performed anywhere, patients are followed remotely by the UCLA investigators Patients scheduled for SRT for recurrence after primary prostatectomy and with PSA ≥ 0 1ng/ml at time of enrollment were eligible Patients were randomized to proceed with standard SRT allowing for any conventional imaging aside from PSMA PET/CT (control arm) or undergo a 68Ga-PSMA-11 PET/CT scan prior to SRT planning (investigational arm) The primary endpoint is the success rate of SRT at 5 years in patients who undergo SRT We report here the preliminary results of a secondary endpoint: the impact of PSMA PET on SRT planning by comparing the pre-randomization RT plans prospectively obtained on surveys before randomization to the actually delivered RT plans obtained after follow-up Results: Enrollment of the trial was complete 193 patients were enrolled from 09 06 2018 to 08 17 2020 7/90 patients (9%) in the control arm dropped-out the study because they underwent a PSMA PET at another institution, while 1/103 (1%) patients of the intervention arm dropped-out due to COVID-19 related complications After a median follow-up of 13 3 months (last follow-up date 09/01/2020), delivered RT plans were obtained in 60/83 (72%) and 70/102 (69%) of patients of the control and the PSMA arms, respectively Median PSA at enrollment was 0 32 ng/ml (IQR 0 17-1 35) and 0 22 ng/ml (IQR 0 14-0 50) in the control and PSMA arms, respectively There was a change between the intended pre-randomization RT plan and the actually delivered RT plan in 17/60 (28%) and 40/70 (57%) of the patients in the control and PSMA arms, respectively (p = 0 002) SRT was aborted in favor of systemic therapy and/or metastasis directed RT for extra-pelvic M1 disease in 2/60 (3%) and 12/70 (17%) of the control and PSMA arms, respectively (p = 0 17) Dose prescription and/or target volume delineation was changed in 2/60 (3%) and 1/70 (26%) in the control and PSMA arms, respectively (p = 0 001) Conclusions: In this prospective randomized phase 3 study, PSMA PET had an impact on the SRT plan in more than half of the patients Long-term follow-up will show if the impact of PSMA PET on SRT planning translates into improved outcome or not.

Instead of objective response rate, disease control rate should be used as the primary endpoint in a randomized phase II trial evaluating non-first-line chemotherapy for non-small cell lung cancer.

The mutation status of tumor tissue DNA (n = 389) of resected stage II-III non-squamous non-small cell lung cancer (Ns-NSCLC) was analyzed using targeted deep sequencing as an exploratory biomarker study (JIPANG-TR) for the JIPANG study, a randomized phase III study of pemetrexed/cisplatin (Pem/Cis) versus vinorelbine/cisplatin (Vnr/Cis).

Methods This is a randomized phase 2, placebo-controlled, double-blind clinical trial in 198 patients to compare efficacy of degarelix plus best supportive care versus placebo plus best supportive care on improving the clinical outcomes of male Veterans who have been hospitalized due to COVID-19.

For patients with NSCLC, two randomized phase II trials also suggested that the addition of a radical local treatment results in encouraging survival data, with a good safety profile.

A total of 486 mCRC patients treated with FOLFIRI/bevacizumab from two randomized phase III trials, TRIBE and FIRE-3, were included in the current study.

Methods: We conducted an open-label multicenter randomized phase III trial (ClinicalTrials.

The aim of multicenter randomized phase 2 study was to determine the efficacy and safety of testosterone in patients with fatigue developed during targeted therapy.

Results Between May 2015 and September 2019, 24 patients enrolled on the first randomized phase II study in chordoma.

CONCLUSION This is the first randomized phase III trial demonstrating that simultaneously integrated boost irradiation was associated with slightly superior quality of life compared to conventional sequential boost irradiation.

Methods VERTU was a multicenter 2:1 randomized phase II trial in patients with newly diagnosed glioblastoma and MGMT-unmethylated promotor status.

Methods: This is a multi-center 1:1 randomized phase II trial to investigate whether the addition of pembrolizumab (200 mg IV every 3 weeks) to SG (10 mg/kg IV days 1+8 every 21 days) improves PFS compared to SG alone in HR+ HER2- MBC that is PD-L1+ by central assessment with 22C3 combined positive score (CPS) ≥ 1 (NCT04448886).

Although early studies showed some promising results in patients with different citogenetic makeup, the large randomized phase 3 Bellini study which confirmed ventetoclax’s high effectivity in t(11;14) patients, proved increased mortality and OS loss in the case of non-t(11;14) patients treated with the drug.

This is in line with recently issued large randomized phase III trial.

MATERIALS/METHODS The ATEMPT trial is a prospective randomized phase II study of adjuvant ado-trastuzumab emtansine (T-DM1) vs.

The Laparoscopic Approach to Cervical Cancer (LACC) trial, a prospective randomized phase III clinical trial reported in 2018, unexpectedly showed inferior oncologic outcomes in laparoscopic radical hysterectomy (LRH) for cervical cancer compared with those in open surgery.

Treatment with SBRT for multiple metastases has been expanded into multiple ongoing randomized phase 2/3 National Cancer Institute-sponsored trials (NRG-BR002, NRG-LU002).

An ongoing randomized phase II trial will determine the efficacy of pCSI compared to photon IFRT in patients with solid tumor LM.

3 months for sorafenib) in a global open-label randomized phase III study and was approved as the new first-line for advanced-stage HCC.

The HOT1401/NJLCG1401 trial, an open‐label randomized phase II trial, was designed to assess the benefit of maintenance therapy in patients with ED‐SCLC who responded to induction therapy.

The combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) and the anti-CD20 monoclonal antibody rituximab has been standard of care for diffuse large B-cell lymphoma (DLBCL) since 2006, based on results from three randomized Phase III clinical trials: GELA/LNH 98-5, Intergroup/E4494, and MInT (1–3).

A meta-analysis of three randomized phase III clinical trials that tested inhibitors of PDL1 (programmed death-ligand 1) or PD1 in more than 1,600 patients with advanced HCC revealed that immune therapy did not improve survival in patients with non-viral HCC.

Moreover, Novak and coworkers recently published the positive results of a placebo-controlled randomized phase 2 study of AADvac1, an active immunotherapy against pathological tau in AD (Novak and others 2021).

In this post hoc analysis, data from teprotumumab-treated patients in the placebo-controlled randomized phases 2 and 3 trials were reviewed.

Methods: IMagyn050 is a double-blind randomized phase 3 trial evaluating the efficacy and safety of adding atezo/placebo to CPB followed by maintenance bevacizumab + atezo/placebo.

Tolerability of inhaled N-chlorotaurine in humans: a double-blind randomized phase I clinical study.

In this context, recent published randomized phase III clinical trials have tested the potential benefits with a different sequencing and/or intensification of the standard components of the trimodal therapy.

In this context, recent published randomized phase III clinical trials tested the efficacy and safety of immunotherapy and traditional chemotherapy with or without targeted drugs as first-line treatment for mCRC patients with MSI-H/dMMR.

Several randomized phase III clinical trials have demonstrated significant clinical benefits—including significantly better overall survival and quality of life—for treatments that combine androgen-deprivation therapy with docetaxel, abiraterone acetate, enzalutamide, apalutamide, and/or radiotherapy to the primary tumour.

The Javelin Head Neck 100 study is the first of several randomized phase III trials to test the addition of an anti-PD1/PD-L1 antibody to chemoradiotherapy (CRT) for locally advanced head and neck squamous cell carcinomas (HNSCC) [1].

Methods: OUTBACK is an international randomized phase III trial of the Gynecologic Cancer InterGroup (GCIG).

In the international randomized phase III RATIFY trial, the multi-kinase inhibitor midostaurin significantly improved overall and event-free survival in patients 18-59 years of age with FLT3-mutated acute myeloid leukemia (AML).

Longi) which present a random selection of 150 patients from a multi-center randomized phase III clinical trial FFCD 2000-05 of patients diagnosed with metastatic colorectal cancer.

Materials and Methods We conducted a multi-center randomized phase II trial to compare the clinical outcomes between pemetrexed plus cisplatin combination therapy followed by maintenance pemetrexed (PC) and pemetrexed monotherapy (P) after failure of first-line EGFR-TKI.

8Background: This NCTN multi-arm randomized phase II modular clinical trial platform utilizes TNT with parallel EAs in LARC.

In this article, a stepwise hypothesis testing procedure is proposed to combine a continuous tumor biomarker with the conventional binary endpoint in a two-arm randomized phase II superiority trial to improve statistical power.

There is only one randomized phase III trial, of moderately hypofractionated high-dose radiotherapy to the prostate-only versus pelvic irradiation and prostate boost, with a sufficiently long follow-up.

To date, only one randomized phase III study showed the benefit of additional capecitabine after neoadjuvant chemotherapy, and international guidelines recommend at least to consider its use, particularly for triple negative breast cancer.

Various randomized phase III clinical trials have compared moderately hypofractionated to normofractionated radiotherapy (RT).

Treatment strategy is fundamentally constructed on the basis of the results of various randomized phase III clinical trials carried out in patients with clear cell RCC (ccRCC).

INTRODUCTION The previous randomized phase 3 trial (SELECT BC) showed that S-1 as a first-line chemotherapy for metastatic breast cancer (MBC) is non-inferior to taxane with respect to overall survival.

This is similar to the results in previous randomized phase 3 trials in more restricted populations of women.