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Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube 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 Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer Clinical research trials and Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube 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 Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer. Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube 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 Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer clinical trial. Participants frequently get the best healthcare available for their Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube 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 Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer  Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer
Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer
For Condition: stage 4 ovarian epithelial cancer,stage 3 ovarian epithelial cancer,peritoneal cavity cancer,Fallopian Tube Cancer
Status: 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. Combining surgery with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy before surgery is more effective than chemotherapy after surgery in treating ovarian, peritoneal, or fallopian tube cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of chemotherapy before surgery with that of chemotherapy after surgery, with or without additional surgery, in treating patients who have stage III or stage IV ovarian cancer, peritoneal cancer, or fallopian tube cancer.
Details: OBJECTIVES: - Compare the overall survival and progression-free survival in patients with stage IIIC or IV ovarian epithelial, peritoneal, or fallopian tube carcinoma treated with neoadjuvant chemotherapy followed by interval debulking surgery versus upfront cytoreductive surgery followed by chemotherapy with or without interval debulking surgery. - Compare the quality of life of patients treated with these regimens. - Compare the different treatment complications in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, method of biopsy, stage, largest tumor size before surgery, and intent to also randomize on EORTC-55012. Patients are randomized to one of two treatment arms. - Arm I: Patients undergo upfront maximal cytoreductive surgery followed by cisplatin or carboplatin IV every 3 weeks for 3 courses. Patients with non-optimal primary debulking may undergo interval debulking surgery at the physician's discretion. All patients then receive an additional 3 courses of the same regimen of chemotherapy. - Arm II: Patients receive chemotherapy as in arm I. Patients with stable or responding disease undergo interval debulking surgery followed by an additional 3 courses of the same regimen of chemotherapy. Second-look surgery is allowed for both arms if clinically indicated. Quality of life (QOL) is assessed prior to treatment, after the third and sixth course of chemotherapy, and at 6 and 12 months after study. Patients who are also randomized on EORTC-55012 follow the QOL assessment schedule for EORTC-55012 only. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 704 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven stage IIIC or IV ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma - If biopsy is not available, evidence of adenocarcinoma by fine needle aspiration allowed if all of the following are true: - Presence of pelvic ovarian mass - Omental cake or other metastasis larger than 2 cm in the upper abdomen and/or regional lymph node metastasis - CA 125/carcinoembryonic antigen ratio greater than 25 (if ratio less than 25, barium enema or colonoscopy AND gastroscopy or radiological examination of the stomach must be negative for primary tumor) - Normal mammography (if CA 125/carcinoembryonic antigen ratio less than 25) - Tumor greater than 2 cm, excluding ovaries, on laparoscopy or CT scan - No brain or leptomeningeal metastases PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 1.25 times upper limit of normal (ULN) Renal: - Creatinine less than 1.25 times ULN Other: - No other serious disabling diseases contraindicating primary cytoreductive surgery or primary platin-based chemotherapy - No other prior primary malignancies except carcinoma in situ of the cervix or basal cell carcinoma of the skin - No psychological, familial, sociological, or geographical condition potentially preventing protocol compliance or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - No other prior procedures except diagnostic biopsy by laparotomy or laparoscopy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IgnaceVergote, , U.Z. Gasthuisberg
Mount Vernon Hospital *Recruiting*
Northwood, England, HA6 2RN
United Kingdom
Recruiting Contact Person 44-1923-826-111
James Cook University Hospital *Recruiting*
Middlesbrough, England, TS4 3BW
United Kingdom
Recruiting Contact Person 44-1642-854-736
Queen Elizabeth The Queen Mother Hospital *Recruiting*
Margate, , CT9 4AN
United Kingdom
Recruiting Contact Person 44-1843-225-544
Royal United Hospital *Recruiting*
Bath, England, BA1 3NG
United Kingdom
Recruiting Contact Person 44-255-824-317
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Contact Person 47-22-93-4000
Martin Luther Universitaet *Recruiting*
Halle, , D-06112
Germany
Recruiting Contact Person 49-345-5570
Hospital Universitario San Carlos *Recruiting*
Madrid, , 28040
Spain
Recruiting Contact Person 34-913-330-3000
Hospital Central de Asturias *Recruiting*
Oviedo, , 33006
Spain
Recruiting Contact Person 34-98-510-6100
Onze Lieve Vrouwe Gasthuis *Recruiting*
Amsterdam, , 1091 HA
Netherlands
Recruiting Contact Person 31-20-599-9111
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting Contact Person 31-24-361-1111
Institut d'Oncologia Corachan *Recruiting*
Barcelona, , 08.017
Spain
Recruiting Contact Person 34-931-280-0022
Nova Scotia Cancer Centre *Recruiting*
Halifax, Nova Scotia, B3H 1V7
Canada
Recruiting Contact Person 902-473-6000
Hospital Universitario 12 de Octubre *Recruiting*
Madrid, , 28041
Spain
Recruiting Contact Person 34-913-390-8003
Innsbruck Universitaetsklinik *Recruiting*
Innsbruck, , A-6020
Austria
Recruiting Contact Person 43-5122-504-2970
Spedali Civili *Recruiting*
Brescia, , 25124
Italy
Recruiting Contact Person 39-30-399-5483
Clatterbridge Centre for Oncology NHS Trust *Recruiting*
Merseyside, England, CH63 4JY
United Kingdom
Recruiting Contact Person 44-151-334-1155
Newfoundland Cancer Treatment and Research Foundation *Recruiting*
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Recruiting Contact Person 709-777-6480
Centre Oscar Lambret *Recruiting*
Lille, , 59020
France
Recruiting Contact Person 33-320-295-959
Cazk Groeninghe - Campus Maria's Voorzienigheid *Recruiting*
Kortrijk, , B-8500
Belgium
Recruiting Contact Person 32-562-34-211
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-3-821-3000
CancerCare Manitoba *Recruiting*
Winnipeg, Manitoba, R3E 0V9
Canada
Recruiting Contact Person 204-787-2241
Kaiser Franz Josef Hospital *Recruiting*
Vienna, , A-1100
Austria
Recruiting Contact Person 43-1-601-9152
Shaare Zedek Medical Center *Recruiting*
Jerusalem, , 91031
Israel
Recruiting Contact Person 972-2-655-5111
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Contact Person 31-71-52-6911
CHUS-Hopital Fleurimont *Recruiting*
Fleurimont, Quebec, J1H 5N4
Canada
Recruiting Contact Person 819-346-1110
Hopital Charles Lemoyne *Recruiting*
Greenfield Park, Quebec, J4V 2H1
Canada
Recruiting Contact Person 514-466-5000
McGill University *Recruiting*
Montreal, Quebec, H2W 1S6
Canada
Recruiting Contact Person 514-398-1444
Meyerstein Institute of Oncology at Middlesex Hospital *Recruiting*
London, England, WIT 3AA
United Kingdom
Recruiting Contact Person 44-20-7436-6464
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa *Recruiting*
Lisbon, , 1099-023 Codex
Portugal
Recruiting Contact Person 351-21-722-9800
Vrije Universiteit Medisch Centrum *Recruiting*
Amsterdam, , 1007 MB
Netherlands
Recruiting Contact Person 31-20-444-4444
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting Contact Person 31-20-566-9111
British Columbia Cancer Agency *Recruiting*
Vancouver, British Columbia, V5Z 4E6
Canada
Recruiting Contact Person 604-877-6000
Hospitais da Universidade de Coimbra (HUC) *Recruiting*
Coimbra, , 3049
Portugal
Recruiting Contact Person 351-239-403-939
Hopital Notre- Dame du CHUM *Recruiting*
Montreal, Quebec, H4L 2M1
Canada
Recruiting Contact Person 514-890-8000
Mirano General Hospital *Recruiting*
Mirano-Venice, , 30035
Italy
Recruiting Contact Person 39-41-579-4111
Libero Istituto Universitario Campus Bio-Medico *Recruiting*
Rome, , 00155
Italy
Recruiting Contact Person 39-6-2254-1366
Fraser Valley Cancer Centre at British Columbia Cancer Agency *Recruiting*
Surrey, British Columbia, V3V 1Z2
Canada
Recruiting Contact Person 604-930-4060
Kingston Regional Cancer Centre *Recruiting*
Kingston, Ontario, K7L 5P9
Canada
Recruiting Contact Person 613-544-2630
Centre Hospitalier Universitaire de Quebec *Recruiting*
Quebec City, Quebec, G1R 2J6
Canada
Recruiting Contact 418-691-5257
Tom Baker Cancer Center - Calgary *Recruiting*
Calgary, Alberta, T2N 4N2
Canada
Recruiting Contact Person 403-270-1700
Cheltenham General Hospital *Recruiting*
Cheltenham, England, GL53 7AN
United Kingdom
Recruiting Contact Person 44-1242-222-222
City General Hospital *Recruiting*
Stoke on Trent, England, ST4 6QG
United Kingdom
Recruiting Contact Person 44-1782-715-444
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-33-2211
Saint John Regional Hospital *Recruiting*
Saint John, New Brunswick, E2L 4L2
Canada
Recruiting Contact 506-648-6884
Ospedale Mauriziano Umberto I *Recruiting*
Torino, , 10128
Italy
Recruiting Contact Person 39-11-508-1111
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-10-463-9222
Academisch Ziekenhuis der Vrije Universiteit Brussel *Recruiting*
Brussels, , 1090
Belgium
Recruiting Contact Person 32-2-477-6040
Additional Information:
Study ID Numbers: CDR0000066721; EORTC-55971
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003636
Other Peritoneal Cavity Cancer Studies:
1. Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer
2. Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
3. Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
4. Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
5. Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum
Related Studies:
Other peritoneal cavity cancer Clinical Trials
Other Clinical Trials
Other Amsterdam Clinical Trials
Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer
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