Clinical trial · Interventional
Induction Chemotherapy, FOLFIRINOX Followed With Concurrent Capecitabine and Radiation Therapy in Inoperable Locally Advanced Cancer of the Pancreas
Induction Chemotherapy, Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX) Followed With Concurrent Capecitabine and Radiation Therapy in Treatment of Patients With Inoperable Locally Advanced Cancer Pancreas
- 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)
This prospective cohort, phase II, trial is studying induction chemotherapy combination, FOLFIRINOX regimen, consisted of oxaliplatin, irinotecan, leucovorin and fluorouracil (5-FU), for 4 cycles, followed by consolidation concurrent radiotherapy with capecitabine in non-progressed cases, in treating patients with locally advanced cancer pancreas.
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 |
|---|---|---|---|
| Cancer of Pancreas | Malignant Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRINOX + CRT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFIRINOX + CRT
- description
- FOLFIRINOX regimen, consisted of oxaliplatin, irinotecan, leucovorin and fluorouracil (5-FU), for 4 cycles, followed by consolidation radiotherapy concurrent with capecitabine 625mg/m2 BID in non-progressed cases, in treating patients with locally advanced cancer pancreas.
- interventionNames
- Drug: FOLFIRINOX + CRT
Primary outcomes (1)
- measure
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability of FOLFIRINOX plus Concurrent Radiotherapy with Capecitabine
- timeFrame
- 6 months after enrolment
- description
- will be carried out, using (CTCAE) Common Terminology Criteria for Adverse Events, Version 4.0
Secondary outcomes (1)
- measure
- Tumor response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Disease characteristics: * Histological and radiological confirmation of locally advanced cancer pancreas * Inoperable disease * Disease must be able to be encompassed within a radical radiotherapy treatment volume * Not metastatic Patient characteristics: * ECOG performance status 0 or 1 * Life expectancy \> 3 months. * Glomerular filtration rate ≥ 60 mL/min. * WBC \> 3,000/mm³. * Absolute neutrophil count \> 1,500/mm³. * Hemoglobin \> 10.0 g/dL. * Platelet count \> 100,000/mm³. * Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN) * Gamma-glutamyl-transferase \< 1.5 times ULN. * Transaminases ≤ 1.5 times ULN. * Bilirubin ≤ 1.5 times ULN. * No medically unstable conditions (e.g., unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcemia, or ischemic heart disease) * Not pregnant or nursing. * No other previous or current malignant disease likely to interfere with protocol treatment or comparisons * No prior chemotherapy or radiotherapy. Exclusion Criteria: * ECOG performance status \> 2 * Life expectancy \< 3 months. * Glomerular filtration rate \< 30 mL/min. * Absolute neutrophil count \< 1,500/mm³. * Alkaline phosphatase \> 1.5 times upper limit of normal (ULN) * Gamma-glutamyl-transferase \> 1.5 times ULN. * Transaminases\>1.5 times ULN. * Bilirubin \>1.5 times ULN. * medically unstable conditions (e.g., unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcemia, or ischemic heart disease) * pregnant or nursing. * prior chemotherapy or radiotherapy.
References
Publications (0)
Data not yet available