Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT00189657
Eligibility Criteria:
Inclusion Criteria:
* rectal adenocarcinoma
* R0 surgery
* T3, N0, M0 or T4, N0, M0 or N1,2, M0
* chemotherapy can be started within 8 weeks after surgery
* Age \> 18
* Performance status ECOG \< 3
* preoperative radiotherapy allowed
* preoperative chemotherapy with 5FU +/- LV allowed
* Neutrophiles \> 1 500/mm3; Pl. \> 100 000/mm3
* Transaminases \< 2 x UNL; Alcalines Phosphatases \< 2 x UNL; Bili \< 1.1 UNL
* creatininemia \< 120 µmol/l and/or clearance of creatininemia \> 60 ml/mn
* Written informed consent before inclusion
Exclusion Criteria:
* postoperative radiotherapy
* Distant metastases
* Contraindication to any drug contained in the chemotherapy regimens
* Any serious active disease or co-morbid medical condition including digestive inflammatory disease
* Gilbert disease
* severe toxicity of radiotherapy
* Pregnancy or breast feeding
* Absence of contraception in non menopausal women
* Adult patient unable to give informed consent because of intellectual impairment
* Concomitant participation to another trial
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00189657
Study Brief:
Protocol Section:
NCT00189657