Introduction to Phase Iii

But it still needs a phase III randomized controlled trial to investigate its clinical utility and promotion, compared to IMRT.

PATIENTS AND METHODS An open-label, phase III, randomized, controlled trial was conducted at Peking University Cancer Hospital & Institute.

Methods A total of 30 patients with EA2 (8 female; aged 20-71 years; 18 genetically confirmed, 4 with a positive family history, 8 with the clinical diagnosis) were enrolled in this phase III, randomized, double-blind, placebo-controlled, 3-period crossover trial.

Methods & Materials: In this 6-month, Phase III, randomized, double-blind study, subjects 18-64 years were administered aboBoNT-A 50 U (N=224) or placebo (N=77), as five 0.

Phase III clinical trials have shown that atezolizumab or pembrolizumab is well-tolerated in combination with chemotherapy, with progression-free survival benefit in metastatic programmed death ligand-1 (PD-L1)-positive TNBC patients treated first line.

The phase III POLO trial showed a near doubling of progression-free survival (PFS) compared with placebo in advanced PDAC when a PARP inhibitor, olaparib, was used as maintenance therapy.

3500Background: In the phase III, randomized open-label KEYNOTE-177 (NCT02563002) study 1L pembrolizumab (pembro) versus chemotherapy (chemo) provided superior progression-free survival (PFS) at se.

A phase III, multicenter, randomized, open-label trial was conducted including 284 adults with vitamin D insufficiency undergoing hemodialysis who were randomly assigned to receive oral calcifediol or standard care for 24 months.

BEATRICE is a phase III randomized clinical trial that examined the efficacy of bevacizumab in patients with triple-negative breast cancer (TNBC).

Design, Setting, and Participants This randomized clinical trial is a post hoc follow-up study that analyzes the results of the open-label Multicentre Randomized Controlled Phase III Trial, which enrolled patients from 13 different centers in France and was conducted from October 26, 2009, to April 4, 2012.

In a recent Phase III randomized, placebo-controlled clinical trial (NCT02750306), patients on suvorexant with AD-dementia and insomnia showed improvements in both PSG total sleep time (TST) and CGI-S scores.

Methods: This retrospective pooled analysis included patients (active and placebo arms) from the following four phase III, randomized, placebo-controlled trials: ASCEND (NCT01366209), CAPACITY (NCT00287729 and NCT00287716), and INSPIRE (NCT00075998).

Methods The trial is a phase III double-blind, randomized, multicenter, parallel group, concurrent, controlled study in hospitalized participants with COVID-19 requiring mechanical ventilation using a sequential design.

Eleven articles were initially selected, and four phase III, double-blind, randomized controlled trials of abiraterone acetate and enzalutamide that involved 5199 patients with mCRPC were included.

Two multicenter, randomized, double-masked, clinical trials (phase II and phase III) evaluated the efficacy of 8 infusions of teprotumumab every 3 weeks vs.

Here, we describe the design and rationale for the multicenter, randomized, double-blind, Phase III KEYNOTE-641 study, which will be conducted to compare the efficacy and safety of pembrolizumab plus enzalutamide with that of enzalutamide plus placebo in mCRPC.

DESIGN This was a double-blind, placebo-controlled, randomised Phase III trial.

Methods This 52-week, multicentre, double-blind, placebo-controlled and active-controlled phase III trial evaluated once-daily oral filgotinib in patients with RA randomised 3:3:2:3 to filgotinib 200 mg (FIL200) or filgotinib 100 mg (FIL100), subcutaneous adalimumab 40 mg biweekly, or placebo (through week 24), all with stable weekly background MTX.

Patients & methods: PACIFIC was a Phase III study of durvalumab versus placebo after CRT in patients with unresectable, stage III non-small-cell lung cancer.

Specific extracts of selected vegetables (SV) have been shown to benefit the survival of stage IIIb/IV non-small cell lung cancer patients in phase I/II studies and is currently in a phase III trial.

The authors provide their expert insight with a focus on Phase III randomised controlled trials (RCT) of bempedoic acid.

All completed Phase III randomised controlled trials evaluating systemic anti-cancer therapies in metastatic gastroesophageal malignancies for the period 01.

Due to the excellent results of the global phase III trial, EV-301, enfortumab vedotin will be the recommended third-line regimen for the treatment of advanced UC patients who previously received both platinum-containing and immune checkpoint inhibitor therapies.

Dear Editor, Although immune checkpoint inhibitors (ICIs) are potential therapeutic agents for hepatocellular carcinoma (HCC), phase III clinical trials failed to show superiority over placebo in terms of prolonging survival [1].

An analysis was conducted using clinical data from Japanese patients in the phase III REFLECT trial to assess the cost-effectiveness of lenvatinib versus sorafenib for first-line treatment of unresectable HCC in Japan.

Pembrolizumab was evaluated in a phase III, open-label, multicentre, randomised trial versus standard of care (SOC: FOLFOX6/FOLFIRI alone or in combination with bevacizumab/cetuximab) as first-line treatment of locally confirmed mismatch repair-deficient or microsatellite instability-high stage IV CRC.

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).

published the first randomized phase III study (OBELICS study) comparing the sequential administration of bevacizumab before standard oxaliplatin-based chemotherapy versus a traditional concomitant regimen in metastatic colorectal cancer (CRC) (5).

Data was derived from two phase III randomised, double-blind, placebo (PBO)-controlled trials: one in pts with r-axSpA, who were biological disease-modifying anti-rheumatic drug (bDMARD)-naïve (COAST-V: NCT02696785), and the other in pts who were tumor necrosis factor inhibitor-experienced (COAST-W: NCT02696798).

The analysis included randomised, double-blind, phase III controlled trials, non-TNF targeted therapies and PASI75 measurement after 12–16 weeks of treatment.

BACKGROUND AND PURPOSE The phase III FLAME trial (NCT01168479) showed an increase in five-year biochemical disease-free survival, with no significant increase in toxicity when adding a focal boost to external beam radiotherapy (EBRT) for localized prostate cancer [Kerkmeijer et al.

PATIENTS AND METHODS We assessed the impact of age on time to tumour recurrence (TTR), disease-free survival (DFS), cancer-specific survival (CSS), and overall survival (OS) in 2360 patients with stage III CC (1667 aged <70 years and 693 ≥ 70 years) randomised to receive 3 or 6 months of FOLFOX or CAPOX within the frame of the phase III, TOSCA study.

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.

Methods: GO41944 (NCT04408638) is a Phase III, open-label, randomized trial designed to evaluate the safety and efficacy of glofitamab plus gemcitabine and oxaliplatin (glofit-GemOx) vs R-GemOx in patients with R/R DLBCL.

Patients and methods This is an international, multicenter, open-label, randomized (1 : 1), two-arm, phase III clinical trial that will enroll 432 patients with newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage III EOC.

METHODS In this international, multicenter, open-label phase III trial, patients with CLM who progressed on oxaliplatin- or irinotecan-based first-line therapy were randomly assigned 1:1 to receive second-line chemotherapy with or without TARE.

Trial design: COMET, a multicenter phase III prospective randomized trial, opened in the U.

Experimental Design: SWOG S1216 is a phase III prospective randomized trial of androgen deprivation therapy (ADT) combined with orteronel or bicalutamide for mCSPC.

In the phase III trial ALTER 0303, anlotinib significantly improved overall survival (OS) and PFS in advanced NSCLC patients.

3526 Background: Compared to placebo, trifluridine/tipiracil (FTD/TPI) significantly improved overall and progression-free survival in patients (pts) with pre-treated metastatic colorectal cancer (mCRC) in the phase III RECOURSE trial.

The CTs included were: phase III, randomised, open label, crizotinib controlled and ALK positive NSCLC.

Methods and design Tenecteplase Reperfusion therapy in Acute ischemic Cerebrovascular Events (TRACE) is a phase III, multicentre, prospective, randomised, open-label, blinded-end point non-inferiority study.

In two phase III trials (CheckMate 017 and CheckMate 057), nivolumab showed an improvement in overall survival (OS) and favorable safety versus docetaxel in patients with previously treated, advanced squamous and nonsquamous NSCLC, respectively.

4044 Background: The phase III ATTRACTION-2 trial demonstrated survival benefit of nivolumab (Nivo) as third- or later-line treatment in previously treated advanced gastric or gastroesophageal junction (GEJ) cancer, with response rate (RR) of 11% (Kang YK, et al.

Purpose: The CeTeG/NOA-09 phase III trial demonstrated a significant survival benefit of lomustine–temozolomide chemoradiation in patients with newly diagnosed glioblastoma with methylated O6-methylguanine-DNA methyltransferase (MGMT) promoter.

Purpose: The CeTeG/NOA-09 phase III trial demonstrated a significant survival benefit of lomustine–temozolomide chemoradiation in patients with newly diagnosed glioblastoma with methylated O6-methylguanine-DNA methyltransferase (MGMT) promoter.

All phase III clinical trials that reported the outcomes of tyrosine kinase inhibitor with radiation therapy compared with those of tyrosine kinase inhibitor or radiation therapy alone for patients with metastatic renal cell carcinoma were considered eligible for inclusion in this meta-analysis.

Here, we report findings from a combined analysis of three phase IIIb studies of afatinib in EGFR tyrosine kinase inhibitor (TKI)-naïve patients.

Objective This analysis reports the healthcare professional global assessment (HPGA) and patient global assessment (PGA) scores and the adverse event (AE) profile by age, body mass index (BMI), sex, and race from the three Phase III registration studies for sufentanil sublingual tablet (SST) 30 mcg.

MATERIALS/METHODS We retrospectively observed the clinical characteristics as well as dose-volume factors in a cohort of 190 patients with local advanced gastric adenocarcinoma in our hospital, including gender, age, treatment group, clinical TNM classification, primary tumor site, hepatitis, body mass index (BMI), alanine aminotransferase (ALT), alkaline phosphatase (ALP), serum albumin (ALB), total bilirubin (TBIL), activated partial thromboplastin time (APTT) from June 2013 to November 2020, based on an ongoing multicentric randomized phase III clinical trial (NCT01815853).

Methods: This was a multicenter, double-blind, randomized (1:1), placebo-controlled phase III clinical trial.

Methods This phase III, multicenter, double-blind, placebo-controlled study (ClinicalTrials.

ACTIVE is the first phase III study conducted in China, evaluating apatinib, a VEGFR2 TKI, plus gefitinib as first-line therapy in EGFR-mutant NSCLC.

Results of the LMS04 trial (NCT02997358), a randomized phase III study comparing the doxorubicin plus trabectedin combination versus doxorubicin alone in first-line therapy in metastatic LMSs, are pending.

In the phase III IMbrave150 trial, combination of atezolizumab and bevacizumab (atezo+bev) resulted in improved overall survival (OS) and progression-free survival (PFS) compared with sorafenib for patients with unresectable hepatocellular carcinoma (uHCC).

In May 2020, the first PARP inhibitor, olaparib, was approved by the US Food and Drug Administration for men with mCRPC with HHR gene mutations based on the findings of the Phase III PROfound trial that showed improved overall survival in men with mCRPC who received olaparib and whose disease had progressed on a novel hormonal agent.

The majority were phase III (63%), and OS was the most common primary end point (40%).

The primary end point of phase III was disease-free survival (DFS) in intention-to-treat analysis.

In this follow-up analysis, using pooled data from the 36-week open-label extensions of the TELESTAR (NCT01677910) and TELECAST (NCT02063659) phase III trials, we demonstrate that improvements in weight and nutritional parameters were sustained or further improved in patients with CS through to week 48 of treatment with TE.

Six patients were excluded from the effectiveness analysis set due to participation in the open-label extension part of the phase III, randomized, double-blind, placebo-controlled REGAIN study [ClinicalTrials.

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.

BACKGROUND The phase III CHAARTED trial established upfront androgen deprivation therapy (ADT) plus docetaxel (D) as a standard for metastatic hormone-sensitive prostate cancer (mHSPC) based on meaningful improvement in overall survival (OS).

In phase III trials, olaparib monotherapy significantly improved progression-free survival (PFS) relative to placebo (SOLO-1), as did olaparib plus bevacizumab relative to placebo plus bevacizumab (PAOLA-1), in patients with advanced ovarian cancer who had responded to platinum-based chemotherapy.

Both agents were approved based on phase III trials demonstrating that they were associated with improved progression-free survival compared with treatment of physician’s choice in patients receiving second-third line therapy for locally advanced, inoperable, or metastatic breast cancer in patients with germline pathogenic BRCA 1 or BRCA2 variants.

The purpose of this clinical trial conducted by Bone and Soft Tissue Tumor Study Group of Japan Clinical Oncology Group (JCOG) is to determine the most promising regimen among trabectedin, eribulin and pazopanib as the test arm regimen in the future phase III trial of the second-line treatment for patients with advanced STS.

Phase III clinical trials have recently suggested the efficacy of novel anti-angiogenic factors such as cabozantinib and ramucirumab as a second-line treatment option.

PATIENTS AND METHODS GAIN-2 was an open-label, randomised, multicentre phase III trial.

METHODS COLUMBUS was a two-part, open-label, randomised, phase III study in patients with BRAF-mutant melanoma.

METHODS NASANIF (NCT03317015) was a double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial in which patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) over 4 weeks.

INTRODUCTION This double-blind, parallel-group, active-controlled phase III trial (NCT02260804) assessed CT-P10 and rituximab safety and efficacy in patients with previously untreated low-tumor-burden follicular lymphoma (LTBFL), including after a single switch from rituximab to CT-P10.

BACKGROUND In the phase III IMpassion130 trial, combining atezolizumab with first-line nanoparticle albumin-bound-paclitaxel for advanced triple-negative breast cancer (aTNBC) showed a statistically significant progression-free survival (PFS) benefit in the intention-to-treat (ITT) and programmed death-ligand 1 (PD-L1)-positive populations, and a clinically meaningful overall survival (OS) effect in PD-L1-positive aTNBC.

Additionally, phase III trials of capivasertib and ipatasertib are already under way in HR+ and triple-negative breast cancer.

The DESTINY-Breast03 study, a randomized, phase III trial pitting the antibody-drug conjugates trastuzumab emtansine and trastuzumab deruxtecan against each other in HER2+ metastatic breast cancer, found remarkable improvements in efficacy and safety for the latter, newer therapy.

Eribulin has substantial activity in patients with pretreated (anthracycline and a taxane) advanced or metastatic breast cancer was confirmed by large-scale phase III clinical trials.

Methods A single-institution phase III randomized study to compare IOERT versus EBRT boost in early-stage breast cancer was conducted as a non-inferiority trial.

Experimental Design: The neoadjuvant phase III NeoALTTO trial enrolled 455 patients with HER2-positive early-stage breast cancer.

METHODS: A systematic literature search was conducted according to the PRISMA statement to identify all randomized Phase III clinical trial data in previously untreated metastatic renal cell carcinoma featuring an immune checkpoint inhibitor combination compared against sunitinib.

Three first line, randomized phase III trials (Keynote 426, Checkmate 9ER and Checkmate 214) relied on predefined statistical criteria to validate the survival advantage of immuno-oncology (IO) based systemic treatment in metastatic renal cell carcinoma (mRCC) relative to Sunitinib.

This study aimed to evaluate the effects of obeticholic acid (OCA) on categorical shifts in GLOBE score, APRI, and both combined, based on data from POISE, a phase III placebo-controlled trial in patients with PBC who had an incomplete response or were intolerant to ursodeoxycholic acid.

In this phase III, placebo-controlled trial, 3730 patients with New York Heart Association class II, III, or IV heart failure and an ejection fraction of 40% or less were randomly assigned to receive either empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy.

Aberrant regulation of angiogenesis involves in the growth and metastasis of tumors, but angiogenesis inhibitors fail to improve overall survival of pancreatic cancer patients in previous phase III clinical trials.

In phase III study (GOLD), olaparib plus paclitaxel did not improve overall survival (OS) compared with paclitaxel in second-line gastric cancer (GC) patients with statistical significance, even though there was absolute increase of OS (Lancet Oncol 2017).

METHODS Study 342 (NCT03201900; FREEDOM) is a single-arm, open-label, Phase III study of perampanel monotherapy.

In a large phase IIIb, single-arm, open-label, multicenter French study, we assessed safety, response to treatment, progression-free survival (PFS) and factors associated with progression, and stratified the population into risk groups.

Objectives: In the Phase III PAOLA-1/ENGOT-ov25 (NCT02477644) trial, the addition of the PARP inhibitor olaparib to bevacizumab maintenance therapy led to a significant progression-free survival (PFS) benefit in patients with newly diagnosed advanced ovarian cancer (hazard ratio [HR] 0.

The Olympia AD phase III trial demonstrated a statistically significant progression-free survival rate (PFS) when using the PARPi olaparib in metastatic BC with germline BRCA1/2 mutations without any benefit of the overall survival rate.

MATERIALS AND METHODS The SAFIA trial is a prospective multicenter, international, double-blind, neoadjuvant phase III trial, using upfront 21-gene Oncotype DX Breast Recurrence Score assay (recurrence score [RS] < 31) to select operable luminal human epidermal growth factor receptor 2–negative patients, for induction hormonal therapy HT (fulvestrant 500 mg with or without goserelin) before randomly assigning responding patients to fulvestrant 500 mg (with or without goserelin) plus either palbociclib (cyclin-dependent kinase 4/6 inhibitor) or placebo.

PURPOSE This analysis evaluated the genomic landscape of premenopausal patients with hormone receptor–positive and human epidermal growth factor receptor 2–negative advanced breast cancer and the association of genetic alterations with response to ribociclib in the phase III MONALEESA-7 trial.

Although this might mistakenly be seen as an issue for the radiation oncology community, all of us who share in the treatment of women with early stage breast cancer should be concerned about the upcoming NRG BR007 trial, a “Phase III Randomized Trial: Evaluating De-escalation of Breast Radiation (DEBRA) for Conservative Treatment of Stage I, HR+, HER2-, RS ≤ 18 Breast Cancer), which is due to open in July.

Although this might mistakenly be seen as an issue for the radiation oncology community, all of us who share in the treatment of women with early stage breast cancer should be concerned about the upcoming NRG BR007 trial, a “Phase III Randomized Trial: Evaluating De-escalation of Breast Radiation (DEBRA) for Conservative Treatment of Stage I, HR+, HER2-, RS ≤ 18 Breast Cancer), which is due to open in July.

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

Methods: EXELOX is an open-label, multicenter, prospective, randomized phase III trial that enrolled 448 previously untreated patients with histologically confirmed advanced gastric adenocarcinoma from 7 hospitals in China.

METHODS We will perform the SACRED Trial (NCT03654053), a phase III, prospective, multi-center, double-blind, randomized clinical trial at 11 VA Medical Centers.

Thus, we initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: the non-inferiority role of applying olanzapine to prevent CINV instead of dexamethasone.

Based on (a) the growing evidence of high efficacy, (b) the fact that aHSCT is safe, well established, and approved for several indications including another autoimmune disease, systemic sclerosis, (c) the fact that phase III clinical trials of aHSCT compared to best available therapy are difficult to perform due to the high cost and lack of support from commercial, private, and government entities, but also due to recruitment difficulties as aHSCT is indicated in a small number of patients with MS, (d) a clear desire of patients with aggressive disease to have access to aHSCT, (e) the fact that many patients with MS are willing to travel to countries where aHSCT is offered widely, and (f) socioeconomic considerations that aHSCT as a one-time treatment will reduce overall disease cost long term, we * P.

So the REACH3 trial is a phase III study comparing ruxolitinib versus best available therapy for steroid-refractory and steroid-dependent chronic GvHD.

Methods A 12-month multicentre, randomised, double-masked, double-sham, parallel controlled, phase III trial (Sailing Study), followed by a 12-month open-label extension study.

Design HAWK was a global, 2-year, randomised, double-masked, multicentre phase III trial in participants with neovascular age-related macular degeneration.

1,2 The recently published phase III FLAURA trial found superior overall survival with osimertinib, a third-generation TKI, compared with the second-generation TKIs gefitinib or erlotinib, in patients with previously untreated EGFR mutation-positive advanced NSCLC.

The confirmatory phase III TOWER trial demonstrated superior overall survival (OS) with blinatumomab compared with standard chemotherapy (7.