Phase
Condition
Digestive System Neoplasms
Rectal Cancer
Colorectal Cancer
Treatment
N/AClinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adenocarcinoma of the rectum cT3 or cT4 or cN+, M0 and for which CPR recommendspreoperative radiochemotherapy
Tumor <15 cm of the anal margin in rigid or subperitoneal rectoscopy at the MRI
Tumor potentially resectable from the outset, or considered to be resectable afterradiochemotherapy
Operable Patient
Age between 18 and 75
OMS performance status 0-2
No co-morbidity likely to prevent the delivery of treatment
Adequate contraception for men, and for non-menopausal women
Neurotrophic neutrophils 1500 / mm3, platelets 100 000 / mm3, and hemoglobin 10 g / dL
Bilirubin ≤ 1.5 times the upper limit of normal (LNS), ASAT and ALAT ≤ 1.5LNS,Alkaline phosphatase ≤ 1.5 LNS
Creatinine clearance> 50 mL / min
Patient must have been informed and must have signed the specific informed consentform.
Patient must be affiliated to a Social Health Insurance.
Exclusion
Exclusion Criteria:
Remote metastasis
Cancer not resectable
Contraindication to capecitabine and its excipients
Previous history of pelvic radiotherapy or previous chemotherapy
History of inflammatory bowel or rectum disease
History of angina pectoris monitored or myocardial infarction or heart failure
Active active infection or other serious underlying condition that may prevent thepatient from receiving treatment
Other concomitant cancer, or history of cancer other than in situ cancer of thetreated cervix or basal cell carcinoma or squamous cell carcinoma
Patient already included in another therapeutic trial with an experimental molecule
Pregnant woman, likely to be pregnant or nursing
Persons deprived of their liberty or under guardianship
Patient unable to comply with the required medical follow-up for geographic, social orpsychological reasons
Study Design
Connect with a study center
CHRU de Besançon
Besançon, 25030
FranceSite Not Available
Centre Gf Leclerc
Dijon, 21000
FranceSite Not Available

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