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Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed Clinical research trials and Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed. Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed clinical trial. Human subjects often get the best healthcare possible for their Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed  Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed
Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed
For Condition: stage 2 rectal cancer,stage 3 rectal cancer,adenocarcinoma of the rectum
Status: No longer recruiting
Sponsor(s): EORTC Radiotherapy Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining radiation therapy and surgery with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare radiation therapy alone before surgery with radiation therapy plus fluorouracil and leucovorin before surgery, with and without fluorouracil and leucovorin after surgery in patients with rectal cancer that can be surgically removed.
Details: OBJECTIVES: - Compare the disease-free and overall survival in patients with resectable adenocarcinoma of the rectum treated with preoperative radiotherapy with or without preoperative fluorouracil (5-FU) combined with leucovorin calcium (CF) and/or postoperative 5-FU/CF. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, sex, tumor location (0-5 vs 6-10 vs 11-15 cm from anal margin), and stage (T3 vs T4). Patients are randomized to 1 of 4 treatment arms. - Arm I: Patients undergo involved-field radiotherapy 5 days a week for 5 weeks followed 3-10 weeks later by abdominoperineal resection or anal-sparing resection according to local practice in the absence of disease progression or unacceptable toxicity. - Arm II: Patients undergo radiotherapy as in arm I beginning on day 1 and leucovorin calcium (CF) IV followed by fluorouracil (5-FU) IV (1 hour before radiotherapy) on days 1-5 and 29-33, followed 3-10 weeks later by resection as in arm I in the absence of disease progression or unacceptable toxicity. - Arm III: Patients undergo radiotherapy followed 3-10 weeks later by resection as in arm I. Within 3-10 weeks after resection, patients receive CF followed by 5-FU on days 1-5. Chemotherapy continues every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. - Arm IV: Patients undergo preoperative radiotherapy with concurrent chemotherapy followed by resection as in arm II and postoperative chemotherapy as in arm III. Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 992 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed resectable adenocarcinoma of the rectum - Any grade - Tumor macroscopically within 15 cm of anal margin on rigid rectoscopy - Tumor tethered or partially fixed on digital rectal exam and/or T3-4 on rectal ultrasound - No acute or subacute bowel obstruction without colostomy diversion - No chronic inflammatory disease of the ileum and/or colon - No primary adenocarcinoma of the anal canal - No distant metastasis PATIENT CHARACTERISTICS: Age: - 80 and under Performance status: - WHO 0-1 Life expectancy: - Not specified Hematopoietic: - Granulocyte count greater than 2,000/mm^3 - Platelet count greater than 130,000/mm^3 Hepatic: - Not specified Renal: - Creatinine less than 1.36 mg/dL Cardiovascular: - No angina pectoris Other: - No other prior malignancy except basal cell skin cancer or carcinoma in situ of the uterine cervix PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic therapy for adenocarcinoma of the rectum Chemotherapy - No prior chemotherapy for adenocarcinoma of the rectum Endocrine therapy - No prior endocrine therapy for adenocarcinoma of the rectum Radiotherapy - No prior radiotherapy for adenocarcinoma of the rectum Surgery - No prior surgery for adenocarcinoma of the rectum
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeanBosset, Study Chair, CHR de Besancon - Hopital Jean Minjoz
Centre Paul Strauss
Strasbourg, , 67085
France
CHR de Besancon - Hopital Jean Minjoz
Besancon, , 25030
France
C.H.U. de Brest
Brest, , 29200
France
Clinique De Valdegour
Nimes, , 30900
France
Institut Catala d'Oncologia - Hospital Duran i Reynals
Barcelona, , 08907
Spain
Centre Hospitalier General
Belfort, , 90000
France
Kantonsspital Basel
Basel, , CH-4000
Switzerland
Centre Hospital Regional Universitaire de Limoges
Limoges, , 87042
France
Hospital General Gregorio Maranon
Madrid, , 28007
Spain
Institut Jules Bordet
Brussels, , 1000
Belgium
Medical University of Gdansk
Gdansk, , 80-211
Poland
Hopital Universitaire Erasme
Brussels, , 1070
Belgium
Centre Hospitalier Universitaire de Tivoli
La Louviere, , 7100
Belgium
Rambam Medical Center
Haifa, , 31096
Israel
UniversitaetsSpital
Zurich, , CH-8091
Switzerland
Institute of Oncology and Radiology of Serbia
Belgrade, , 11000
Yugoslavia
CHR de Grenoble - La Tronche
Grenoble, , 38043
France
Centre Paul Papin
Angers, , 49036
France
Hospital General Universitari Vall d'Hebron
Barcelona, , 08035
Spain
Centre Oscar Lambret
Lille, , 59020
France
Hopital Jean Bernard
Poitiers, , 86021
France
Dr. Bernard Verbeeten Instituut
Tilburg, , 5042 SB
Netherlands
Clinique Sainte Elisabeth
Namur, , 5000
Belgium
Hopital Civil de Charleroi
Charleroi, , 6000
Belgium
Institut Sainte Catherine
Avignon, , 84082
France
Service Cancerologie Polyclinique Clairval
Marseille, , 13009
France
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, , 21079
France
Centre Hospitalier Universitaire Henri Mondor
Creteil, , 94010
France
Centre Saint-Yves
Vannes, , 56001
France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
Krankenhaus des Kreises Hameln-Pyrmont
Hameln, , 31785
Germany
Dokuz Eylul University School of Medicine
Izmir, , 35340
Turkey
Clinique Sainte Clotilde
Sainte Clotilde, , 97492
France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , 37044
France
Additional Information:
Study ID Numbers: CDR0000078308; EORTC-22921
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002523
Other Stage 3 Rectal Cancer Studies:
1. Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer
2. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
3. Combination Chemotherapy With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
4. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer
5. Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed
Related Studies:
Other stage 3 rectal cancer Clinical Trials
Other Clinical Trials
Other Angers Clinical Trials
Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed
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