Clinical trial · Interventional
Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer
Feasibility of an Immediate Preoperative Chemotherapy Before Resection of Colorectal Cancer and Research of Gene Expressions Changes Induced in the Tumor, Predictive of Chemotherapy Efficiency
NCT01715363CI-TRIAL-00020873PRIMMterminatedPhase 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): Recruitment difficulties
Summary
Brief summary (as posted)
The purpose of this study is to analyze the clinical tolerance of immediate preoperative chemotherapy in terms of toxicity and perioperative morbidity and mortality
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 |
|---|---|---|---|
| Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorouracile | Drug | — | UNRESOLVED |
| Folinic Acid | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFOX + surgery + FOLFOX
- description
- * Systemic chemotherapy (modified FOLFOX 4) 48 hours before surgery * resection of the colorectal tumor during surgery * Resumption of FOLFOX within the month after surgery (post operative administration of 4 course of treatment and assessment of the response)
- interventionNames
- Drug: Oxaliplatin
- Drug: Folinic Acid
- Drug: Fluorouracile
Primary outcomes (1)
- measure
- Clinical tolerance of immediate preoperative chemotherapy
- timeFrame
- Assess up to 30 days after surgery
- description
- Clinical tolerance of immediate preoperative chemotherapy assessment is based on the post-operative complication rate in terms of morbidity and mortality. All the post-operative complications arising within 30 days after surgery will be registered and classified using the Clavien Dindo classification
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * colorectal metastatic adenocarcinoma (stage IV) with unresectables, measurables and visibles secondary lesions * primitive tumor must be operate * patient age between 18 and 70 * OMS status performance \< 2 * life expectancy \> 12 weeks * hematologic function : PNN \>/= 1.5x10\^9/L, platelets \>/= 100x10\^9/L * hepatic function : bilirubin \</= 1.5xLSN, AST and ALT \</= 3xLSN, alcalin phosphatasis \</= 3xLSN * plasmatimic creatin \</= 1.25xLSN * No previous chemotherapy or pelvic radiotherapy * men and women in age of procreate agreeing to use a contraception until 4 months after the end of treatment for women and until 6 months for men Exclusion Criteria: * nonmetastatic forms * Colorectal tumor which requires preoperative radiotherapy * nonmeasurable metastasis based on RECIST criteria * previous chemotherapy for colorectal cancer * previous irradiation of the primitive tumour * specific indication against the treatment studied * Patient considered as inoperable for physiological or carcinologic reasons * Pregnant or breast feeding women
References
Publications (0)
Data not yet available
No reference posted for this study.