Clinical trial · Interventional
Impact of FOLFIRINOX Chemotherapy in IV Stage Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin
Re-Play: Impact of FOLFIRINOX Chemotherapy in IV Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this work is to verify prospectively what the rate of response after triple chemotherapy with mFOLFIRINOX in patients in IV stage of Colorectal Cancer who have already failed after at least two lines of dual combinations with fluoropyrimidine, oxaliplatin, irinotecan and anti-EGFR if wild-type RAS. Currently at ICESP, patients are frequently re-exposed in third line to double combinations.
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 |
|---|---|---|---|
| Colorectal Cancer Stage IV | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mFOLFIRINOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- mFolfirinox
- interventionNames
- Drug: mFOLFIRINOX
Primary outcomes (1)
- measure
- Assess response rate after 4 cycles of FOLFIRINOX
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- Progression-free survival
- timeFrame
- 2 years
- measure
- Overall Survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of metastatic colon/rectal adenocarcinoma, with measurable by RECIST v. 1.1 * Disease progression to at least two lines of chemotherapy with chemotherapy regimens that contain fluoropyrimidine, irinotecan and oxaliplatin * Patients with RAS research in tumor sample with result wild animals must have previously received anti-EFGR therapy. * ECOG (Eastern Cooperative Oncology Group) 0 or 1 * Availability of tumor material for molecular analysis * Hb \> 8, neutrophils \> 1,500 and PLQ \> 100,000 * Adequate kidney and liver function Exclusion Criteria: * Active neoplasm with other primary site, except in situ tumors * Contraindication to treatment with fluoropyrimidine, oxaliplatin and irinotecan, including previous unmanageable G3 or greater toxicities, in previous exhibitions. * Presence of comorbidities that, according to the investigator's assessment, may compromise participant safety * Prior exposure to the FOLFIRINOX regimen * Pregnant or lactating women * Total bilirubin above 1.5mg/dL * Hepatic transaminases greater than 3 times the upper limit of normality
References
Publications (0)
Data not yet available