Clinical trial · Interventional
Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
NCT00112658CI-TRIAL-00050516completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer. PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Folfirinox
- interventionNames
- Drug: fluorouracil
- Drug: irinotecan hydrochloride
- Drug: leucovorin calcium
- Drug: oxaliplatin
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine
- interventionNames
- Drug: gemcitabine hydrochloride
Primary outcomes (2)
- measure
- Objective response rate (Phase II)
- measure
- Survival (Phase III)
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* No other pancreatic tumor type, including either of the following:
* Neuroendocrine tumor
* Acinar cell tumor
* Metastatic disease
* Measurable disease in an area not previously irradiated
* No cerebral metastases or meningeal involvement of the tumor
PATIENT CHARACTERISTICS:
Age
* 18 to 75
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (biliary drainage allowed)
Renal
* Creatinine \< 120 mmol/L
Cardiovascular
* No prior myocardial infarction
* No prior angina
* No uncompensated cardiac or coronary insufficiency
* No symptomatic arrhythmia
Gastrointestinal
* No prior inflammatory bowel disease
* No prior chronic diarrhea
* No unresolved symptomatic occlusion or subocclusion of the bowel
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No ongoing active infection
* No other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No contraindication to study treatment
* No other serious medical disorder that would preclude study treatment
* No psychiatric disorder or social or geographic situation that would preclude study participation
* Not detained or under the guardianship of another person
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy
Surgery
* Not specified
Other
* No concurrent participation in another clinical trial using therapeutic experimental agentsReferences
Publications (3)
- RESULTConroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923. PMID 21561347
- RESULTYchou M, Desseigne F, Guimbaud R, et al.: Randomized phase II trial comparing folfirinox (5FU/leucovorin [LV], irinotecan [I] and oxaliplatin [O]) vs gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma (MPA): first results of the ACCORD 11 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-4516, 2007.
- DERIVEDLambert A, Jarlier M, Gourgou Bourgade S, Conroy T. Response to FOLFIRINOX by gender in patients with metastatic pancreatic cancer: Results from the PRODIGE 4/ ACCORD 11 randomized trial. PLoS One. 2017 Sep 20;12(9):e0183288. doi: 10.1371/journal.pone.0183288. eCollection 2017. PMID 28931010