|- candidate number||8749|
|- NTR Number||NTR2644|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-dec-2010|
|- Secondary IDs||80-82310-97-11056 ZonMw|
|- Public Title||Is een kijkoperatie nuttig om te bepalen of een operatie voor eierstokkanker zal slagen.|
|- Scientific Title||Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients.|
|- hypothesis||Laparoscopy is more reliable than standard diagnostic work up to predict the result of primary debulking surgery in patients with advanced ovarian cancer. |
|- Healt Condition(s) or Problem(s) studied||Ovarian cancer, Laparoscopy, Minimally invasive surgical procedures, Debulking|
|- Inclusion criteria||1. Age between 18 and 80 y;|
2. Scheduled for primary cytoreductive surgery because of suspicion of having advanced ovarian cancer;
3. Signed informed consent.
|- Exclusion criteria||1. WHO performance status ≥ 3;|
2. Intrahepatic metastatic disease > 1 cm;
3. Extra-abdominal metastatic disease (excl. inguinal lymph nodes or pleural fluid);
4. Imaging suggestive of:
A. Peri-aortic lymphadenopathy larger than 1 cm above the level of the renal veins;
B. Extensive peritoneal carcinosis at the diaphragmatic level which gives the impression that complete cytoreduction is impossible;
C. Extensive bowel mesentery involvement.
5. Large immobile pelvic tumor, probably requiring bowel resection for complete debulking;
6. Contra-indication for laparoscopic surgery.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2011|
|- planned closingdate||1-mei-2014|
|- Target number of participants||200|
|- Interventions||Randomization between standard diagnostic work-up or added laparoscopy.|
|- Primary outcome||Percentage of primary cytoreductive surgery with more than 1 cm of residual tumor.|
|- Secondary outcome||1. Frequency of complete (no residual tumor) cytoreduction;|
2. Frequency of less than 1 cm of residual tumor after cytoreduction;
3. Progression free survival;
4. Overall survival;
6. Quality of life;
|- Timepoints||1. After laparoscopy;|
2. After primary cytoreduction;
3. After interval cytoreduction;
4. After last chemotherapy;
|- Trial web site||www.studies-obsgyn.nl|
|- CONTACT FOR PUBLIC QUERIES||Dr. Marrije R. Buist|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Marrije R. Buist|
|- Sponsor/Initiator ||Academic Medical Center (AMC, Amsterdam)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: |
Complete cytoreductive surgery, when no residual tumor is left at laparotomy, prolongs survival of patients with advanced ovarian cancer. In contrast, suboptimal cytoreductive surgery, defined as residual tumor of more than 1 cm in diameter at any anatomic site, does not have any survival benefit, will increase the number of complications, and will reduce quality of life of patients. Hence, it should be avoided. At present it is not clear which tests are best suitable to identify patients for debulking surgery. We will study the cost-effectiveness of laparoscopy for identifying patients who will benefit from primary surgery, distinguishing them from those that should be treated with neoadjuvant chemotherapy and interval surgery instead. Diagnostic laparoscopy added to the standard clinical and CT evaluation in selecting patients eligible for primary debulking surgery is likely to be more reliable in prediction of suboptimal surgery.
Adding laparoscopy to conventional staging in patients suspected of advanced ovarian carcinoma could prevent unnecessary laparotomy, thus limiting morbidity and costs.
To investigate whether laparoscopy is cost-effective in predicting which patients will benefit from primary surgery and which patients should be treated with neoadjuvant chemotherapy and interval surgery instead.
A multicenter randomized trial.
Women between 18-80 years suspected of having advanced stage ovarian carcinoma (FIGO >IIB), who are eligible for primary debulking surgery after conventional staging and have given written informed consent.
We will randomly assign patients after conventional staging to either primary surgery, without laparoscopy, or to additional laparoscopy to guide the decision between primary surgery followed by chemotherapy and neoadjuvant chemotherapy plus interval surgery.
Main study parameters/endpoints:
Primary outcome will be futile laparotomy, defined as suboptimal primary cytoreductive surgery, when the diameter of the largest residual tumor metastasis at the end of the surgery is more than 1 cm.
Secondary outcomes will be no residual tumor, less than 1 cm residual tumor after cytoreductive surgery, progression free survival, overall survival, morbidity, quality of life, days in hospital, and costs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients randomised for additional staging laparoscopy will have an extra surgical intervention under general anaesthesia. Diagnostic laparoscopy is a routinely performed technique by gynaecologists, with a low complication rate. The open technique is thought to be the safest in our group of patients.
If laparoscopy proves to be cost-effective in improving the frequency of complete and optimal debulking with equal or better survival rate, this procedure will be added to conventional staging in all patients. Therefore future patients will benefit from this trial.
Tumor tissue samples collected for translational research will be taken during surgery and blood samples will be obtained combined with other laboratory tests or during surgery to minimize patientís burden.
|- Main changes (audit trail)|
|- RECORD||8-dec-2010 - 17-dec-2010|