Secondary Debulking Surgery +/- Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT00426257 |
Recruitment Status :
Completed
First Posted : January 24, 2007
Last Update Posted : August 24, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer | Procedure: Secondary debulking Procedure: secondary debulking with intraperitoneal chemotherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 242 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase III Randomised Clinical Trial for Stage III Ovarian Carcinoma Randomising Between Secondary Debulking Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | August 16, 2017 |
Actual Study Completion Date : | August 16, 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Secondary debulking surgery with hyperthermic intraperitoneal chemotherapy
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Procedure: secondary debulking with intraperitoneal chemotherapy
secondary debulking with intraperitoneal chemotherapy |
Active Comparator: 2
Secondary debulking surgery
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Procedure: Secondary debulking
Secondary debulking |
- Duration of recurrence free survival.
- Toxicity and morbidity
- Quality of life
- Tumour response
- Overall survival
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Ages Eligible for Study: | 18 Years to 76 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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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)
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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
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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)
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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
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426257
Netherlands | |
The Netherlands Cancer Institute | |
Amsterdam, Netherlands, 1066CX |
Study Chair: | Willemien J van Driel, MD | The Netherlands Cancer Institute |
Responsible Party: | The Netherlands Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00426257 |
Other Study ID Numbers: |
M06OVH-OVHIPEC 2006-003466-34 ( EudraCT Number ) 2006-16 ( Other Grant/Funding Number: Commissie Klinische Studies ) |
First Posted: | January 24, 2007 Key Record Dates |
Last Update Posted: | August 24, 2018 |
Last Verified: | August 2017 |
Ovarian Cancer stage III hyperthermic intraperitoneal chemotherapy debulking surgery HIPEC |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Hyperthermia Fever Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Body Temperature Changes Heat Stress Disorders Wounds and Injuries |