Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression
- 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, such as fluorouracil, leucovorin, cisplatin, and gemcitabine, 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) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- LV5FU2 simplifié + cisplatine puis gemcitabine si progression
- description
- LV5FU2 simplifié + cisplatine puis gemcitabine si progression
- interventionNames
- Drug: cisplatin
- Drug: fluorouracil
- Drug: gemcitabine hydrochloride
- Drug: leucovorin calcium
- type
- EXPERIMENTAL
- label
- gemcitabine puis LV5FU2 simplifié + cisplatine si progression
- description
- gemcitabine puis LV5FU2 simplifié + cisplatine si progression
- interventionNames
- Drug: cisplatin
- Drug: fluorouracil
- Drug: gemcitabine hydrochloride
- Drug: leucovorin calcium
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the pancreas or ampulla * Metastatic disease * Unresectable disease * Measurable disease, meeting the following criteria: * No prior radiotherapy to the only site of measurable disease * Diameter \> 10 mm by spiral CT scan or MRI OR \> 20 mm by conventional methods * No brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 2 months * No contraindication to chemotherapy * Creatinine clearance \> 60 mL/min * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Alkaline phosphatase \< 5 times normal * Bilirubin ≤ 3 mg/dL * No coronary insufficiency * No symptomatic cardiac disease * Good hydration possible * No Child-Pugh class B or C cirrhosis * No other malignancy except for basal cell skin cancer or carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior palliative or adjuvant chemotherapy * At least 4 weeks since prior radiotherapy * No radiotherapy during or for 4 weeks after study therapy * No other concurrent anticancer therapy
References
Publications (1)
- RESULTDahan L, Bonnetain F, Ychou M, Mitry E, Gasmi M, Raoul JL, Cattan S, Phelip JM, Hammel P, Chauffert B, Michel P, Legoux JL, Rougier P, Bedenne L, Seitz JF; Federation Francophone de Cancerologie Digestive. Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2-CDDP) followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: final results of a randomised strategic phase III trial (FFCD 0301). Gut. 2010 Nov;59(11):1527-34. doi: 10.1136/gut.2010.216135. PMID 20947887