Clinical trial · Interventional
Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
A Randomized Phase II Study Of Gemcitabine Plus Radiotherapy Vs. Gemcitabine, 5-Fluorouracil And Cisplatin Followed By Radiotherapy And 5-Fluoraracil For Patients With Locally Advanced, Potentially Resectable Pancreatic Adenocarcinoma
- 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens combining chemotherapy with radiation therapy in treating patients who are undergoing surgery for locally advanced 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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| epoetin alfa | Biological | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage of margin-free resections produced by each program
Secondary outcomes (7)
- measure
- Efficacy as measured by CT scan response
- measure
- Post-treatment fibrosis in the resected specimens
- measure
- Toxicity
- measure
- Duration of objective response
- measure
- Disease-free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the pancreas * No adenosquamous cancers or adenocarcinoma associated with cystic mucinous neoplasms * Locally advanced disease that is potentially resectable, previously explored and considered unresectable, or deemed to require preoperative treatment for other reasons * Primary cancer in the head, body, or tail of pancreas * Measurable disease * No 360 degree encirclement of the superior mesenteric artery, hepatic artery, or celiac axis * No metastases by CT scan and laparoscopy (if prior surgery, only CT scan required) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count greater than 2,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic * Bilirubin less than 2 mg/dL (unless secondary to bile duct blockage by tumor) * Biliary obstruction by tumor requires biliary stent at least 9 French or biliary bypass before therapy Renal * Creatinine less than 1.7 mg/dL OR * Creatinine clearance greater than 60 mL/min Other * No other malignancy within the past 3 years except nonmelanoma skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for this disease Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to pancreas Surgery * Not specified
References
Publications (1)
- RESULTLandry J, Catalano PJ, Staley C, Harris W, Hoffman J, Talamonti M, Xu N, Cooper H, Benson AB 3rd. Randomized phase II study of gemcitabine plus radiotherapy versus gemcitabine, 5-fluorouracil, and cisplatin followed by radiotherapy and 5-fluorouracil for patients with locally advanced, potentially resectable pancreatic adenocarcinoma. J Surg Oncol. 2010 Jun 1;101(7):587-92. doi: 10.1002/jso.21527. PMID 20461765