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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Japanese Gynecologic Oncology Group.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Japanese Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00226915
First received: September 23, 2005
Last updated: April 2, 2012
Last verified: April 2012

September 23, 2005
April 2, 2012
April 2003
June 2012   (final data collection date for primary outcome measure)
Progression Free Suvaival [ Time Frame: During the protocol treatment then 18 months from the last day of the protocol treatment ] [ Designated as safety issue: No ]
Progression-free Survival
Complete list of historical versions of study NCT00226915 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: During the protocol treatment then 18 months from the last day of the protocol treatment ] [ Designated as safety issue: No ]
  • Adverse Event [ Time Frame: During the protocol treatment then 18 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: During the protocol treatment then 18 months ] [ Designated as safety issue: No ]
  • Overall Suvival
  • Adverse Event
  • Clinical Objective Response
  • Quality of life
Not Provided
Not Provided
 
Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Epithelial Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
637
June 2012
June 2012   (final data collection date for primary outcome measure)

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)
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00226915
JGOG3016, C000000183 (by UMIN)
Yes
Japanese Gynecologic Oncology Group
Japanese Gynecologic Oncology Group
Not Provided
Study Chair: Makoto Yasuda, M.D. The Jikei University School of Medicine
Japanese Gynecologic Oncology Group
April 2012

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