Overview

This trial is active, not recruiting.

Conditions fallopian tube cancer, ovarian cancer, primary peritoneal cancer
Treatment carboplatin and paclitaxel
Phase phase 2
Sponsor Korean Gynecologic Oncology Group
Start date March 2010
End date March 2014
Trial size 314 participants
Trial identifier NCT01570582, KGOG3017

Summary

purpose Primary endpoint

- To evaluate the 24 month disease free survival Second endpoints

- To evaluate the 24 month overall survival To analyze the toxicity and the quality of life

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects assigned to Arm I Neople taksoljuwa Latin week the first day of the week based outpatient / inpatient treatment receive it. The subjects first received taksoljureul given over 3 hours followed by 30 minutes will be administered Neople Latin week. Subjects assigned to Arm II Gemcitabine and Latin Neople every week based on the first day of the outpatient / inpatient treatment receive it. The subjects first received Gemcitabine given over 30 minutes followed by 30 minutes will be administered Neople Latin week. Gemcitabine and eighth day of the foreign / hospitalization are given over 30 minutes. Regimen of the progression of the disease, the subject can not continue to deny or toxic dose every 3 weeks until at least 6 cycles should be administered to. Subjects completed six cycles of medication which responds subjects, the researchers believe it is necessary to sustain if the regimen is
carboplatin and paclitaxel carboplatin , paclitaxel and Gemcitabine
Subjects assigned to Arm I Neople taksoljuwa Latin week the first day of the week based outpatient / inpatient treatment receive it. The subjects first received taksoljureul given over 3 hours followed by 30 minutes will be administered Neople Latin week.

Primary Outcomes

Measure
24month progression free survival
time frame: 24 months

Secondary Outcomes

Measure
Toxicity Profile
time frame: 24 months

Eligibility Criteria

Female participants from 18 years up to 70 years old.

Inclusion Criteria: - Patients with epithelial ovarian, fallopian tube cancer bokmakam or pathological diagnosis of recurrent states there must be must be present. - Pathologically Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (NOS) have been diagnosed with possible participation. - Patients with CA-125 (biochemical recurrence), as described below elevation or clinically measurable lesions or the measurement is not possible, as there should be evidence of recurrence. - If at least one (record as the longest diameter) can be accurately measured in at least one lesion that is defined. For each lesion, such as MRI or CT, when measured by traditional methods should be at least 20mm spiral CT (spiral CT) have been measured to be less than 10mm when. - Neutrophil (ANC) by 1500 / ㎣ more Platelet count 100,000 / ㎣ more Serum creatinine concentration 1.5mg/dL (133mol / l) or creatinine clearance less than 60ml/min should be at least two. Exclusion Criteria: - Patients must be at least 18 years of age. - Patients with epithelial ovarian, fallopian tube cancer bokmakam or pathological diagnosis of recurrent states there must be must be present.

Additional Information

Official title A Phase II Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Description Approximately 48 month from the date of IRB approval Patients enrolled in this study targets approximately 314 people. Completion of patient enrollment is expected to take approximately 24 month, approximately 24 month follow-up period is expected to be needed
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Korean Gynecologic Oncology Group.