Secondary Debulking Surgery +/- Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Ca… (NCT00426257) | Clinical Trial Compass
CompletedPhase 3
Secondary Debulking Surgery +/- Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer
Netherlands242 participantsStarted 2007-02
Plain-language summary
This study evaluates the efficacy and safety of the addition of hyperthermic intraperitoneal chemotherapy to secondary debulking surgery in stage III ovarian cancer.
Who can participate
Age range18 Years – 76 Years
SexFEMALE
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Inclusion Criteria:
* Age between 18 and 76 years
* Histological or cytological proven primary epithelial ovarian carcinoma or peritoneal cancer (PPSC) or fallopian tube carcinoma FIGO stage III, including serous papillary adenocarcinoma, mucinous adenocarcinoma and endometrioid adenocarcinoma.
* In case of pleural effusion cytology should be negative for tumour cells
* In case diagnosis is made based on cytology only (i.e. patients treated by primary chemotherapy) additional criteria apply:
* Normal mammogram (\< 6 weeks before first registration) and
* Presence of pelvic mass and
* CA 125 \> 200 kU/l and
* Serum CA125/CEA ratio \> 25. If the serum CA125/CEA ratio is \< 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for the presence of a primary tumour of the digeste tract (\< 6 weeks before registration) and
* Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size (CT/MRI or ultrasound or laparoscopy)
* Patients eligible for interval debulking for the following 2 reasons:
* Primary debulking surgery not feasible due to tumour extension or general condition (patients treated by primary chemotherapy) or
* Incomplete primary debulking with residual disease \> 1 cm
* In case of primary chemotherapy:
* Chemotherapy consists of 3 courses of carboplatin or cisplatin combined with taxol
* Following 2 cycles of chemotherapy…