Secondary Debulking Surgery +/- Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer

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 at least a 30% decrease in the sum of largest diameter (LD) of target lesions taking as reference the baseline sum LD (RECIST criteria, see appendix 1)

• In case of an incomplete primary debulking as indicated under 5 followed by chemotherapy:

  • Chemotherapy consists of 3 courses of carboplatin or cisplatin combined with taxol

• General criteria:

  • Fit for major surgery, ASA 1 or ASA 2
  • WHO performance status 0-2
  • Written informed consent
  • Laboratory values: serum creatinine < 140 µmol/L; creatinine clearance > 60 ml/min (Cockroft formula); white blood cell count > 3.5 x 109/l; platelets > 100 x 109 /l

• For quality of life studies:

  • Baseline questionnaires should be filled in before randomization

Exclusion Criteria:

• History of breast cancer or previous malignancies within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix