Surgery for recurrent platinum-sensitive epithelial ovarian cancer
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To compare progression-free survival after treatment with secondary cytoreduction followed by chemotherapy (experimental arm) and treatment with chemotherapy alone (control arm) in patients with recurrent platinum sensitive epithelial ovarian cancer
A multicenter prospective randomized trial
- Women, age 18 years or older
- First recurrence of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer (FIGO stage Ic-IV)
- First-line treatment consisted of complete or optimal (less or equal to 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 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)
- Ascites < 500 ml (pocket < 8 cm on ultrasound examination)
- Complete resection seems possible (estimated by a gynecologic oncologist)
- Able to be treated with secondary cytoreductive surgery and/or at least six cycles of intravenous platinum containing chemotherapy
- Written informed consent
We will randomly assign patients to the control arm and experimental arm. In the control arm patients receive the standard treatment for platinum-sensitive recurrent ovarian cancer of at least six cycles of intravenous platinum containing chemotherapy. In the experimental arm treatment consists of secondary cytoreductive surgery followed by at least six cycles of intravenous platinum containing chemotherapy
Primary outcome will be progression free survival, defined as the interval between date of randomization and date of progressive disease or death of any cause, whatever occurs first. Secondary outcomes will be overall survival, quality of life, surgery related morbidity and mortality, toxicity and tumor response following treatment in the two arms.
Median progression free survival of patients in the control arm is expected to be about 10 months. An increase in median progression free survival of at least 5 months in favor of secondary cytoreductive surgery is acceptable given the expected morbidity. To obtain a power of 80%, 104 patients should be enrolled in each group to detect a constant hazard ratio of 1.5 with a 0.05 two-sided significance level assuming an accrual period of 5 years with 3 years of further follow-up. Including 10% loss to follow up, 115 patients are needed in each group. Simulations showed that this number is sufficient even in case of the worst case scenario, i.e. up to 5% of subjects dying due to surgery.
Start study: 06-07-2012
First year (0-12 months): start of study in all participating centers
First-fifth year (0-60 months): inclusion of 230 patients, data collection
Sixth-Eighth year (60-96 montsh): interim-analysis, follow-up
Last year (84-96 months): analysis of data, preparation of manuscripts
Prof. Dr. L.F.A.G. Massuger, gynaecologist-oncologist, Radboud University Nijmegen Medical Centre
Prof. Dr. R.F.P.M. Kruitwagen, gynaecologist-oncologist, Maastricht University Medical Centre
Ir. J. in het Hout, statistician, Dept of Epidemiology, Biostatistics and HTA, Radboud University Nijmegen Medical Centre
Drs. R. van de Laar, gynaecologist
Radboud University Nijmegen Medical Centre
Phone: 0031 (24)- 3614755
You can find more information about Gynecological Oncology trials on the Dutch Gynecological Oncology Group (DGOG) website.
For more information, please contact Willemien Driel: firstname.lastname@example.org.