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Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer Clinical research trials and Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer. Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer clinical trial. Participants frequently get the best healthcare available for their Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer  Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer
Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer
For Condition: stage 2 ovarian epithelial cancer,stage 3 ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): Medical Research Council ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with surgery may kill more tumor cells. It is not yet known whether chemotherapy plus surgery is more effective than chemotherapy alone in treating patients with stage II or stage III ovarian cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without surgery in treating patients with stage II or stage III ovarian cancer.
Details: OBJECTIVES: I. Determine the impact of interval debulking surgery, in terms of survival, disease-free survival, and quality of life, in patients with newly diagnosed stage II or III ovarian cancer and residual macroscopic disease greater than 1 cm after primary surgery. PROTOCOL OUTLINE: This is a randomized study of debulking surgery with concurrent chemotherapy. Patients are randomized to receive chemotherapy alone (arm I) or chemotherapy and interval debulking surgery (arm II). Arm I: Patients receive six courses of platinum-based chemotherapy at intervals of 3 weeks. Arm II: Patients receive three courses of platinum-based chemotherapy at intervals of 3 weeks. In the absence of disease progression, patients undergo interval debulking surgery approximately 21 days after initiation of the third course of chemotherapy. Surgery is then immediately followed by three additional courses of platinum-based chemotherapy. Patients are followed at 6 months after randomization, then every 3 months for the remainder of the first 2 years, then every 6 months for the following 3 years, and then annually thereafter. Quality of life is assessed prior to randomization and before the fourth course of chemotherapy, and then at follow-up visits at 6 months and 1, 2, and 3 years. PROJECTED ACCRUAL: There will be 1,000 patients accrued into this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed newly diagnosed stage II or III ovarian epithelial cancer - Must be planning to receive platinum-based chemotherapy - Must be fit for interval debulking surgery - Residual macroscopic disease with longest dimension of largest tumor mass greater than 1 cm in diameter documented at primary surgery or postoperatively by imaging --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: Not specified - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Other: No concurrent or prior malignancy likely to interfere with protocol treatments or comparison
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IanJacobs, Study Chair, Medical Research Council
Saint Bartholomew's Hospital
London, England, EC1A 7BE
United Kingdom
Additional Information:
Study ID Numbers: CDR0000066799; MRC-OV06,EU-98063
Study Start Date: May 1998
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003695
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. Combination Chemotherapy in Treating Women With Stage III Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
2. Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
3. Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors
4. Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
5. Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
Related Studies:
Other stage 3 ovarian epithelial cancer Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer
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