Clinical trial · Interventional
Oxaliplatin in Rectal Cancer
Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer
NCT00259363CI-TRIAL-00002851terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study cancelled because recruitment rate was too slow
Summary
Brief summary (as posted)
* 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Phase I : Maximum Tolerated Dose & Recommended Dose
- timeFrame
- Days 1, 15, 29
- measure
- Phase II : Response and resectability rate.
- timeFrame
- 6 cycles in 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.