Clinical trial · Interventional
Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Non-Metastatic Pancreatic Cancer
A Phase I Study of Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Locally Unresectable Non-Metastatic Pancreatic Cancer
- 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 study is to test a new treatment of pancreatic cancer that cannot be removed by surgery. This treatment is a Phase I dose escalation research study which will combine one drug at increasing doses with a fixed dose of a second drug and radiation therapy. The drug that will be used at increasing doses is gemcitabine whereas 5-fluorouracil will remain the same for all patients.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Radiation Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-FU/gemcitabine/RT
- interventionNames
- Drug: Gemcitabine
- Drug: 5-Fluorouracil
- Procedure: Radiation Therapy
Primary outcomes (1)
- measure
- To assess the maximum tolerated dose of weekly gemcitabine when administered with continuous infusion 5-fluorouracil and external beam radiation.
- timeFrame
- phase 1
Secondary outcomes (2)
- measure
- To determine the safety if this regimen
- timeFrame
- phase 1
- measure
- to obtain a preliminary assessment of the efficacy of this regimen in this patient population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic confirmation of locally unresectable pancreatic adenocarcinoma. Patients with either measurable of evaluable disease are eligible. * Unresectable, non-metastatic tumors. Unresectable patients include those with local extension of the tumor into adjacent structures and/or nodal metastasis. * Total bilirubin \< 2.0 mg/dl * AST \< 3x ULN * Serum creatinine \< 2.0 mg/dl * WBC \> 3,000/mm3 * Platelets \> 100,000/mm3 * ECOG performance status \< or = to 2 * Life expectancy of greater than 12 weeks Exclusion Criteria: * Evidence of peritoneal seeding by malignancy * Prior radiation therapy or chemotherapy for pancreatic cancer * Myocardial infarction in the past 6 months * Major surgery in past two weeks * Uncontrolled serious medical or psychiatric illness * Pregnant or lactating women * Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
References
Publications (0)
Data not yet available