Phase 3
Completed N=74
Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer
Source: ClinicalTrials.gov NCT00057876 ↗Enrolled (actual)
74
Serious AEs
81.2%
Results posted
Mar 2011
Primary outcomePrimary: Overall Survival Time — 9.2; 11.0 Months — p=0.017
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival Time |
9.2; 11.0 | 0.017 sig |
| SECONDARY Progression-free Survival Time |
6.7; 6.0 | 0.25 |
| SECONDARY Overall Response |
2; 2 | 0.99 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00057876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.