Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
The Netherlands Cancer Institute |
---|---|
Information provided by: | The Netherlands Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00426257 |
This study evaluates the efficacy and safety of the addition of hyperthermic intraperitoneal chemotherapy to secondary debulking surgery in stage III ovarian cancer.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer |
Procedure: Debulking surg Procedure: Debulking surg + Hyperthermic Intraperitoneal CT |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase III Randomised Clinical Trial for Stage III Ovarian Carcinoma Randomising Between Secondary Debulking Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy |
Estimated Enrollment: | 280 |
Study Start Date: | February 2007 |
Ages Eligible for Study: | 18 Years to 76 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
In case diagnosis is made based on cytology only (i.e. patients treated by primary chemotherapy) additional criteria apply:
Patients eligible for interval debulking for the following 2 reasons:
In case of primary chemotherapy:
In case of an incomplete primary debulking as indicated under 5 followed by chemotherapy:
General criteria:
For quality of life studies:
Exclusion Criteria:
Contact: Willemien J van Driel, MD | +31 20 512 2975 | w.v.driel@nki.nl |
Netherlands | |
The Netherlands Cancer Institute | Recruiting |
Amsterdam, Netherlands, 1066CX | |
Principal Investigator: Willemien van Driel, MD |
Study Chair: | Willemien J van Driel, MD | The Netherlands Cancer Institute |
Study ID Numbers: | M06OVH-OVHIPEC, eudract 2006-003466-34, CKTO 2006 16 |
Study First Received: | January 23, 2007 |
Last Updated: | February 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00426257 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Ovarian Cancer stage III hyperthermic intraperitoneal chemotherapy debulking surgery |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer |
Carcinoma Fever Genital Diseases, Female Signs and Symptoms Neoplasm Metastasis Endocrinopathy Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Body Temperature Changes Adnexal Diseases |