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Home > "N" Clinical Trials Conditions > Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma  Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma
Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma
For Condition: stage 3 colon cancer,adenocarcinoma of the rectum,Stage 4 rectal cancer,adenocarcinoma of the colon,stage 3 rectal cancer,stage 4 colon cancer
Status: Recruiting
Sponsor(s): GERCOR ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so that it can be removed. PURPOSE: Phase II trial to study the effectiveness of neoadjuvant radiation therapy combined with capecitabine in treating patients who are undergoing surgery for stage III or stage IV colorectaladenocarcinoma.
Details: OBJECTIVES: Primary - Determine the objective tumor response rate in patients with stage III or IV colorectal adenocarcinoma treated with neoadjuvant radiotherapy and capecitabine. Secondary - Determine the tolerance profile of this regimen in these patients. - Determine the rate of preservation of functional integrity of the anal sphincter in patients treated with this regimen. - Compare the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily and undergo concurrent radiotherapy 5 days a week on weeks 1-5. Patients undergo surgery on week 6. Patients are followed every 4 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed colorectal adenocarcinoma - Clinical stage T3, T4, N+ - Measurable disease - Awaiting surgery and likely to benefit from neoadjuvant radiotherapy PATIENT CHARACTERISTICS: Age - 18 to 80 Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN - No hepatic condition that would interfere with study medication Renal - Creatinine clearance at least 80 mL/min - No renal condition that would interfere with study medication Cardiovascular - No serious cardiac failure with the past year - No myocardial infarction within the past year - No cardiac insufficiency - No angina - No uncontrolled arrhythmia - No uncontrolled hypertension Gastrointestinal - No superior intestinal tract malfunction - No malabsorption syndrome Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No concurrent serious infection - No other serious illness - No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix - No metabolic condition that would interfere with study medication - No dementia or altered mental status - No psychiatric illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for colorectal cancer Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for colorectal cancer Surgery - Not specified Other - More than 30 days since prior participation in another clinical study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
OlivierDupuis, , Centre Jean Bernard
Centre Hospitalier de Mulhouse *Recruiting*
Mulhouse, , 68051
France
Recruiting M. Noirclerc 33-89-647-221
Hopital Drevon *Recruiting*
Dijon, , 21000
France
Recruiting Michel Flesch 33-380-364-822
Centre Jean Bernard *Recruiting*
Le Mans, , 72000
France
Recruiting Olivier Dupuis 33-2-4339-1300
Centre Regional Francois Baclesse *Recruiting*
Caen, , 14076
France
Recruiting Brigitte Vie 33-02-31-455-020
Hopital Saint - Louis *Recruiting*
La Rochelle, , 17000
France
Recruiting Paitel 33-546-455321
Centre Medico-Chirurgical Foch *Recruiting*
Suresnes, , 92151
France
Recruiting May Mabro 33-1-4625-2168
Hopital Notre-Dame de Bon Secours *Recruiting*
Metz, , 57038
France
Recruiting Sabine Walter 33-387-553-554
C.H. Senlis *Recruiting*
Senlis, , 60309
France
Recruiting Elisabeth Carola 33-3-4421-7000
Hopital Saint-Louis *Recruiting*
Paris, , 75475
France
Recruiting Christophe Hennequin 33-1-4249-4949
Hopital Tenon *Recruiting*
Paris, , 75970
France
Recruiting Thierry Andre 33-1-6177-0708
Intercommunal Hospital *Recruiting*
Montfermeil, , 93370
France
Recruiting Mostefa Bennamoun 33-1-4850-1808
Clinique Saint Jean *Recruiting*
Lyon, , 69008
France
Recruiting Gerard Gledo 33-4-7878-1010
Additional Information:
Study ID Numbers: CDR0000346895; EU-20329,FRE-GERCOR-R01-01
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075556
Other Stage 3 Colon Cancer Studies:
1. Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
2. Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
3. Capecitabine in Treating Older Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed
4. Tocladesine in Treating Patients With Recurrent or Progressive Metastatic Colorectal Cancer
5. Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Related Studies:
Other stage 3 colon cancer Clinical Trials
Other Clinical Trials
Other La Rochelle Clinical Trials
Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma
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