Rectal Neoplasms
Conditions
Brief summary
* Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study * Phase II: To determine the treatment efficacy according to response rates from phase I.
Interventions
DRUGOxaliplatin
oxaliplatin 60/mg/m2/15 days, 5-FU 225 mg/m2/day 5 weeks during radiotherapy (RT) 45 Gys/25 days
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. Main criteria are listed hereafter: Inclusion Criteria: * ECOG: 0-2 * Histological proved rectal adenocarcinoma * No chemotherapy treatment on the previous 6 months before inclusion. * No previous pelvic radiotherapy treatment
Exclusion criteria
* Important Biological abnormality (renal, hepatic and/or hematological) * Intestinal occlusion or subocclusion * Peripheral neuropathy * Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test. * Participation in other trials on the previous 4 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I : Maximum Tolerated Dose & Recommended Dose | Days 1, 15, 29 |
| Phase II : Response and resectability rate. | 6 cycles in 6 months |
Countries
Spain
Outcome results
None listed