|
Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Chemotherapy With or Without Surgery in Treating Patients With Recurrent 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 Recurrent Ovarian Cancer Clinical research trials and Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer. Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer  Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer
Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer
For Condition: recurrent ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): EORTC Gynecological Cancer Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy with or without surgery in treating patients who have recurrent epithelial ovarian cancer.
Details: OBJECTIVES: - Compare survival and progression free survival in patients with ovarian epithelial cancer after receiving treatment with chemotherapy with or without secondary cytoreductive surgery. - Determine the toxicity of these treatment regimens in these patients. - Determine the complications related to surgical treatment in these patients. - Compare the quality of life in these patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage at initial diagnosis (early stage I-IIa vs advanced stage IIb-IV), length of interval from end of prior first line chemotherapy (1-2 years vs more than 2 years), response to first 3 courses of second line induction chemotherapy in this study (no change vs partial remission vs complete remission), number of measurable tumor lesions (1 vs more than 1), largest tumor size of recurrence (less than 5 cm vs 5 cm or more), and participating center. Patients receive second line induction chemotherapy with either 3 courses of a 3-4 week regimen or 6 courses of a weekly regimen of platinum based (cisplatin or carboplatin) therapy. Patients with no change, partial remission, or complete remission are randomized to one of two treatment arms. - Arm I: Patients undergo secondary cytoreductive surgery within 14 days of randomization. Within 8 weeks after the last preoperative chemotherapy course, patients continue platinum based chemotherapy every 3-4 weeks for at least 3 additional courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients continue platinum based chemotherapy for at least 3 additional courses as in arm I. Quality of life is assessed at baseline; before the 4th or 6th course of chemotherapy or 1 week before surgery; after the 6th course of chemotherapy in the chemotherapy only arm OR before the 4th or 6th course of chemotherapy in the surgery arm; 2 months after chemotherapy or after the 6th course of chemotherapy in the surgery arm; and then every 6 months for up to 5 years. Patients are followed every 3 months for 2 years, and then every 6 months for 3 years or until disease progression. PROJECTED ACCRUAL: Approximately 700 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed recurrent ovarian epithelial cancer after first line chemotherapy, unless clear evidence of clinically progressive disease - Must have received prior first line chemotherapy consisting of at least 4 courses of either cisplatin or carboplatin - At least 12 months since prior chemotherapy - Measurable disease by clinical exam or diagnostic laparoscopy - At least one lesion greater than 1 cm in diameter - No leptomeningeal or brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 1.25 times upper limit of normal (ULN) - SGPT less than 2 times ULN Renal: - Creatinine less than 1.6 mg/dL OR - Creatinine clearance greater than 40 mL/min Other: - No peripheral neurotoxicity greater than grade 2 - No psychological, familial, sociological, or geographical condition that would preclude study - No complete bowel obstruction - No other malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No more than 1 prior regimen of chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GiuseppeFavalli, Study Chair, Spedali Civili
Spedali Civili
Brescia, , 25123
Italy
Additional Information:
Study ID Numbers: CDR0000068224; EORTC-55963
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006356
Other Recurrent Ovarian Epithelial Cancer Studies:
1. Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
2. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Persistent or Platinum Refractory Stage III or IV Ovarian Cancer
3. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Advanced Ovarian Epithelial Cancer
4. Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
5. Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
Related Studies:
Other recurrent ovarian epithelial cancer Clinical Trials
Other Clinical Trials
Other Brescia Clinical Trials
Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer
|
|
|
|
|
|
|
|
