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Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00226915
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Japanese Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE September 23, 2005
First Posted Date  ICMJE September 27, 2005
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE April 2003
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2020)		 Progression Free Suvaival [ Time Frame: During the protocol treatment then 18 months from the last day of the protocol treatment ]
From the registration date, the earliest observed event from any of the following events 1. Death from any cause death date 2. The date of the first diagnostic imaging examination that confirmed exacerbation and recurrence. Clinical exacerbation diagnosis date if not based on diagnostic imaging 3. If none of the above events are observed, the most recent outpatient consultation date / in hospital
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2005)		 Progression-free Survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2020)
  • Overall Survival [ Time Frame: During the protocol treatment then 18 months from the last day of the protocol treatment ]
    The period from the registration date to the date of death due to any cause. In the case of survivors, the final surviving confirmation date will be censored. In the case of untraceable cases, the last surviving confirmation date before tracking becomes impossible will be censored.
  • QOL [ Time Frame: During the protocol treatment then 18 months ]
    QOL assessed by FACT-Taxane(Version 4A)
  • Adverse Event [ Time Frame: During the protocol treatment then 18 months ]
    Adverse Event assessed by CTC(Version 2.0 Japanese version)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2005)
  • Overall Suvival
  • Adverse Event
  • Clinical Objective Response
  • Quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma
Official Title  ICMJE Randomized Phase III Trial of Conventional Paclitaxel and Carboplatin Versus Dose Dense Weekly Paclitaxel and Carboplatin in Patients With Newly Diagnosed Stage II-IV Mullerian Carcinoma
Brief Summary The purpose of the study is to compare progression-free survival of conventional paclitaxel and carboplatin vs weekly paclitaxel and carboplatin in patients with newly diagnosed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Detailed Description

This is a randomized, multicenter study. Patients are stratified according to residual disease 1 cm or less vs more than 1cm, stage II vs III vs IV, and histology (clear cell or mucinous vs. serous or others). Patients are randomized to one of two treatment arms.

Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 60 minutes on day 1 for 6-9 cycles.

Arm II: Patients receive paclitaxel IV over 1 hour days 1, 8, and 15 and carboplatin IV over 60 minutes on day 1 for 6-9 cycles.

In both arms, cycles repeat 6 cycles every 21 days in the absence of disease progression or unacceptable toxicity. Additional 3 cycles are given if clinical partial or complete response after 6 cycles.

PROJECTED ACCRUAL: A total 600 patients (300 per treatment arm) will be accrued for this study within 3 years. Assuming median progression-free survivals of 16 months and 21 months and a recruitment period of 3 years this can be achieved by recruiting 600 patients designed to have 80 % detect to a difference between the two arms at the two-sided 5% level of statistical significance.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Epithelial Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
Intervention  ICMJE
  • Drug: Paclitaxel+Carboplatin
    Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles
  • Drug: Paclitaxel+Carboplatin
    Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles
Study Arms  ICMJE
  • Active Comparator: 1
    Drug: Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles
    Intervention: Drug: Paclitaxel+Carboplatin
  • Experimental: 2
    Drug: Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles
    Intervention: Drug: Paclitaxel+Carboplatin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2007)		 637
Original Enrollment  ICMJE
 (submitted: September 26, 2005)		 600
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • No prior chemotherapy
  • Age: 20 and more
  • Performance status: ECOG 0-3
  • 1) Absolute neutrophil count at least 1,500/mm3 2) Platelet count at least 100,000/mm3 3) Bilirubin less than 1.5mg/dL 4) SGOT less than 100 IU/l 5) Serum creatinine less than 1.5mg/dL
  • Written informed consent

Exclusion Criteria:

  • Patients with ovarian borderline tumor
  • Patients who have any evidence of the other cancer present within the last 5 years with the exception of carcinoma in situ or intramucosal cancer that is curable with local therapy
  • Patients with active infection or uncontrolled diabetes
  • Patients with unstable angina, or those who have had a myocardial infarction within the past 6 months, or patients with serious arrythmia that requires medication
  • Patients who have a history of hypersensitivity to polyoxyethylated castor oil (Cremophor EL)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00226915
Other Study ID Numbers  ICMJE JGOG3016
C000000183 (by UMIN)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Japanese Gynecologic Oncology Group
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Japanese Gynecologic Oncology Group
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Makoto Yasuda, M.D. The Jikei University School of Medicine
PRS Account Japanese Gynecologic Oncology Group
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP