Clinical trial · Interventional
Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
Infusional 5-Fluorouracil With or Without Cisplatin and With or Without Chronomodulation Against Locally-Advanced or Metastatic Pancreatic Cancer. A Multicenter Randomized Phase III Trial.
- 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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether fluorouracil plus cisplatin are more effective than fluorouracil alone in treating patients with metastatic cancer of the pancreas. PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil with or without cisplatin in treating patients who have advanced or metastatic cancer of the 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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologic or cytologic proof of adenocarcinoma of the exocrine pancreas or of a metastasis associated with a radiologically identified pancreatic tumor * Locally advanced and/or metastatic pancreatic cancer * No measurable or evaluable target lesion is required * No brain metastasis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 40%-100% Hematopoietic: * WBC at least 3,000/mm\^3 * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 3 times normal Renal: * Creatinine no greater than 1.24 mg/dL OR * Creatinine clearance at least 80 mL/min Cardiovascular: * No overt cardiac disease Other: * No peripheral neuropathy * No uncontrolled infectious or chronic disease * No second primary except in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunologic therapy Chemotherapy: * No prior chemotherapy allowed Endocrine therapy: * No concurrent hormonal therapy * At least 2 weeks since corticoid treatment Radiotherapy: * No prior radiotherapy allowed except as an analgesic treatment on metastasis Surgery: * Not specified
References
Publications (0)
Data not yet available