Clinical trial · Interventional
Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer
A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic 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 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine + 5FU + XRT
- description
- Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer
- interventionNames
- Drug: fluorouracil
- Drug: gemcitabine hydrochloride
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 9 months up to 3 years post treatment
Secondary outcomes (4)
- measure
- Time to progression
- timeFrame
- After 2 cycles of tx, then q 2 mon for 1 yr then q 3 mon for 2 yrs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed pancreatic adenocarcinoma
* Non-metastatic disease that is unresectable due to any of the following:
* Tumor greater than 5 cm
* Bulky lymph nodes greater than 2 cm, but within the radiation port
* Vascular involvement or impingement of major vessels
* Involvement of colon, adrenal glands, or kidney
* Measurable or evaluable disease
* No prior therapy for pancreatic adenocarcinoma
* No peritoneal seeding or other evidence of metastatic disease by laparotomy or laparoscopy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* CTC 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* AST no greater than 3 times upper limit of normal
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No myocardial infarction within the past 6 months
Other:
* No other uncontrolled serious medical or psychiatric illness that would preclude study compliance
* No other malignancy within the past 5 years except limited or curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* No prior abdominal radiotherapy
Surgery:
* At least 2 weeks since prior major surgeryReferences
Publications (1)
- RESULTMamon HJ, Niedzwiecki D, Hollis DR, et al.: Preliminary analysis of Cancer and Leukemia Group B (CALGB) 80003: a phase II trial of gemcitabine, 5-fluorouracil (5FU), and radiation therapy (RT) in locally advanced non-metastatic pancreatic adenocarcinoma. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-22, S13, 2005.