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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00426257
Recruitment Status : Completed
First Posted : January 24, 2007
Last Update Posted : August 24, 2018
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Brief Summary:
This study evaluates the efficacy and safety of the addition of hyperthermic intraperitoneal chemotherapy to secondary debulking surgery in stage III ovarian cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Procedure: Secondary debulking Procedure: secondary debulking with intraperitoneal chemotherapy Phase 3

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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
Procedure: secondary debulking with intraperitoneal chemotherapy
secondary debulking with intraperitoneal chemotherapy

Active Comparator: 2
Secondary debulking surgery
Procedure: Secondary debulking
Secondary debulking

Primary Outcome Measures :
  1. Duration of recurrence free survival.

Secondary Outcome Measures :
  1. Toxicity and morbidity
  2. Quality of life
  3. Tumour response
  4. Overall survival

Information from the National Library of Medicine

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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
  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00426257

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The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066CX
Sponsors and Collaborators
The Netherlands Cancer Institute
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Study Chair: Willemien J van Driel, MD The Netherlands Cancer Institute
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: The Netherlands Cancer Institute 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
Keywords provided by The Netherlands Cancer Institute:
Ovarian Cancer
stage III
hyperthermic intraperitoneal chemotherapy
debulking surgery
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries