Phase III randomised clinical trial for stage III ovarian carcinoma randomising between secondary debulking surgery with or without hyperthermic intraperitoneal chemotherapy (OVHIPEC-I) - OVHIPEC-I

• Conditions: ovarian carcinoma or peritoneal cancer (PPSC) or fallopian tube carcinoma FIGO Stage III

• Registration Number: EUCTR2006-003466-34-NL
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

1.age between 18 and 76 years
2. 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 andenocarcinoma.
3.in case of pleural effusion cytology should be negative for tumour cells

4.In case diagnosis is made based on cytology only (i.e. patients treated by
primary chemotherapy) additional criteria apply:
?Normal mammogram (< 6 weeks before 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 lymphnode metastasis irrespective of size (CT/MRI or ultrasound or laparoscopy)

5.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

6.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)

7.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

8.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

9.For quality of life studies:
-baseline questionnaires should be filled in before randomization

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

creatinin clearance < 60 ml/min according to Cockcroft-Gault formula
-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified