A randomized controlled multicenter phase III trial comparing cytoreductive surgery followed by intravenous chemotherapy versus intravenous chemotherapy alone for recurrent platinum-sensitive ovarian cancer
- Conditions
- cancer of the ovariesovarian cancer1003859410029903
- Registration Number
- NL-OMON35952
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 230
• Age >= 18 years
• First recurrence of histologically or cytologically proven epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer of FIGO stage Ic-IV (FIGO system 1988)
• First-line treatment consisted of complete or optimal (<= 1 cm) cytoreductive
surgery and a minimum of six courses (neo-adjuvant) platinum-taxol based chemotherapy
• A clinically disease-free interval of at least 6 months after end of first-line
treatment, the latter defined as the day the last chemotherapy was administered
• First recurrence defined as clinical and radiological signs (CT-scan) of
recurrence or elevated CA 125 (GCIG criteria) and radiological signs (CT-scan)
• If there is any doubt whether or not an abnormal finding on CT-scan is
recurrent ovarian cancer, confirmation of recurrence with cytological or histological
investigation is warranted
• Good performance status (ECOG 0-1)
• Ascites < 500 ml (pocket < 8 cm on ultrasound examination)
• Complete resection seems possible (estimated by a gynecologic oncologist)
• Adequate hematological, renal, and hepatic function to permit platinum
based chemotherapy: WBC > 3.0 x 10*/L, platelets > 100 x 10*/L, serum
creatinine < 1.25 x upper normal range (40-90 µmol/L), serum bilirubin < 1.25 x upper normal
range (< 17 µmol/L)
• Informed consent must be obtained and documented according to national
and local regulatory requirements and the local rules followed in the institution before
randomization
• Quality of life baseline questionnaires should be filled in after informed
consent, preferably before randomization but at least before start treatment
• Participation in interfering trial
• Non-epithelial or borderline ovarian tumours
• Other primary malignancy except for carcinoma in situ and basal or
squamous cell carcinoma of the skin
• Patients with platinum-refractory or resistant tumours
• Intra-abdominal metastatic disease that hampers complete cytoreduction
• Extra-abdominal metastatic disease that hampers complete cytoreduction
• Palliative surgery already planned (e.g. bowel surgery)
• Patients with secondary, third and later recurrence
• Any disease, medical history or medication not allowing surgery and/or
platinum based chemotherapy
• Prior therapy with respect to recurrence
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Comparing progression free survival (defined as the interval between date of<br /><br>randomization and progressive disease or death of any cause) in the two<br /><br>study-arms </p><br>
- Secondary Outcome Measures
Name Time Method <p>Comparing overall survival (defined as the interval between date of<br /><br>randomization and date of death), quality of life, morbidity, mortality,<br /><br>toxicity and tumour response following treatment in the two arms.<br /><br>With respect to secondary cytoreductive surgery : determining the effect of<br /><br>complete and incomplete surgery on progression free survival and overall<br /><br>survival, identifying predictive factors and criteria for patient selection for<br /><br>complete surgery.</p><br>