5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer
NCT00189657
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- 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
- 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
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| Descriptive Information | |||||||||||||||||||
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| Brief Title ICMJE | 5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer | ||||||||||||||||||
| Official Title ICMJE | Not Provided | ||||||||||||||||||
| Brief Summary | The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative radiotherapy is recommended but not mandatory. Main endpoint is disease free survival. Secondary endpoint are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 600 patients will be included in the trial. | ||||||||||||||||||
| Detailed Description | Not Provided | ||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||
| Study Phase ICMJE | Phase 3 | ||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||||||||||||
| Condition ICMJE | Cancer of the Rectum | ||||||||||||||||||
| Intervention ICMJE |
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| Study Arms ICMJE | Not Provided | ||||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||||||||
| Recruitment Information | |||||||||||||||||||
| Recruitment Status ICMJE | Unknown status | ||||||||||||||||||
| Enrollment ICMJE | Not Provided | ||||||||||||||||||
| Original Enrollment ICMJE | Not Provided | ||||||||||||||||||
| Study Completion Date ICMJE | Not Provided | ||||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||||
| Accepts Healthy Volunteers ICMJE | Not Provided | ||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
| Listed Location Countries ICMJE | France | ||||||||||||||||||
| Removed Location Countries | |||||||||||||||||||
| Administrative Information | |||||||||||||||||||
| NCT Number ICMJE | NCT00189657 | ||||||||||||||||||
| Other Study ID Numbers ICMJE | AERO-R98 | ||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||||||||||||||
| Responsible Party | Not Provided | ||||||||||||||||||
| Study Sponsor ICMJE | Association Européenne de Recherche en Oncologie | ||||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Association Européenne de Recherche en Oncologie | ||||||||||||||||||
| Verification Date | September 2005 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||||||||||||||