Clinical trial · Interventional
Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer
A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable 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)
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer. PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine
- interventionNames
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Gemcitabine + Radiation
- interventionNames
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Overall Survival Time
- timeFrame
- assessed every 3 months for 2 years, then every 6 months for year 3
- description
- Overall survival was defined as the time from randomization (registration) to death from any cause. Patients alive at last follow-up were censored. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients received treatment beyond 3 years were also followed for survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the pancreas * Locally advanced or regional (encompassable within the same radiotherapy portals) * Adenosquamous cancers are allowed * Unresectable disease * Measurable and/or non-measurable disease as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI), which must be performed within 4 weeks prior to randomization. * Age\>=18 * ECOG Performance status of 0-1 * Life expectancy \>= 12 weeks * Adequate bone marrow reserve,liver and renal function within 2 weeks of randomization: * Absolute granulocyte count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or cholangitis) * Serum glutamic-oxaloacetic (AST) less than 5 times upper limit of normal (ULN) * Albumin greater than 2.5 g/dL * Creatinine no greater than 1.5 times ULN * Fertile patients must use effective contraception * Willing and able to attend follow-up visits * Concurrent enrollment on protocol ECOG-E1Y03 allowed * More than 4 weeks since prior investigational agents Exclusion Criteria: * Candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0) * Stage M1 disease * Small cell, mucinous cystadenocarcinoma, islet cell or papillary cystic histology * Pregnant or nursing * Active infection within within 4 weeks of randomization * Malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score no greater than 7) * History of active collagen vascular disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma) * Signs or symptoms of peptic or duodenal ulcer disease * Concurrent serious systemic disorders that are incompatible with study participation * Prior chemotherapy for pancreatic cancer * Prior radiotherapy * Concurrent intensity modulated radiotherapy
References
Publications (1)
- RESULTLoehrer PJ, Powell ME, Cardenes HR, et al.: A randomized phase III study of gemcitabine in combination with radiation therapy versus gemcitabine alone in patients with localized, unresectable pancreatic cancer: E4201. [Abstract] J Clin Oncol 26 (Suppl 15): A-4506, 2008.