A Phase IIclinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
This trial is active, not recruiting.
|Conditions||fallopian tube cancer, ovarian cancer, primary peritoneal cancer|
|Treatment||carboplatin and paclitaxel|
|Sponsor||Korean Gynecologic Oncology Group|
|Start date||March 2010|
|End date||March 2014|
|Trial size||314 participants|
|Trial identifier||NCT01570582, KGOG3017|
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
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
24month progression free survival
time frame: 24 months
time frame: 24 months
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.
|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|
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