Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer

Phase 3

Completed

Conditions: Pancreatic Cancer

Interventions: Radiation: radiation therapy
Drug: Gemcitabine

Registration Number: NCT00057876

Lead Sponsor: Eastern Cooperative Oncology Group

Brief 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.

Detailed Description: OBJECTIVES:

* Compare the overall survival and progression-free of patients with locally advanced, unresectable pancreatic cancer treated with gemcitabine with or without radiotherapy.

* Compare the objective response rate in patients treated with these regimens.

* Compare the toxicity of these regimens in these patients.

* Compare the quality of life (QOL) of patients treated with these regimens.

* Determine the effect of gemcitabine and radiotherapy on the QOL of patients with improved objective response rate and progression-free and overall survival.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs. 1) and weight loss within the past 6 months (less than 10% vs. 10% or more). Patients are randomized to 1 of 2 treatment arms.

Arm I (Gemcitabine alone):

* Induction: Patients receive gemcitabine intravenously (IV) over 30-60 minutes once weekly for 6 weeks followed by 1 week of rest.

* Consolidation: After the 1 week of rest, patients receive gemcitabine IV once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Arm II (Gemcitabine with radiotherapy):

* Induction: Patients receive gemcitabine IV over 30-60 minutes once weekly for 6 weeks beginning on day 1. Patients also undergo concurrent radiotherapy 5 days a week for 5.5 weeks beginning on day 1.

* Consolidation: Approximately 4 weeks after completion of radiotherapy, patients receive gemcitabine IV over 30-60 minutes once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, week 6, week 15 (for arm II), week 16 (for arm I), and 9 months.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year. Patients who receive treatment beyond 3 years are followed for survival.

ACCRUAL: 74 patients were accrued for this study.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 74

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine + Radiation	radiation therapy	-
Gemcitabine	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Overall Survival Time	assessed every 3 months for 2 years, then every 6 months for year 3	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival Time	assessed every 3 months for 2 years, then every 6 months for year 3	Time from randomization (registration) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the baseline sum longest diameter), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients who received treatment beyond 3 years were also followed for survival.
Overall Response	assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3	Response was assessed per Response Evaluation Criteria In Solid Tumors (RECIST) by CT. Overall response included complete response (CR) and partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as CR of target lesions and persistence of one or more non-target lesions or at least a 30% decrease in the sum of the longest diameters of target lesions and non-progressive disease in the non-target lesions. The 71 eligible, treated participants were included in the analysis.

Trial Locations

Locations (227): Banner Good Samaritan Medical Center
🇺🇸
Phoenix, Arizona, United States
Saint Joseph's Mercy Cancer Center
🇺🇸
Hot Springs, Arkansas, United States
California Cancer Center - Woodward Park Office
🇺🇸
Fresno, California, United States
Doctors Medical Center
🇺🇸
Modesto, California, United States
Memorial Medical Center Cancer Services
🇺🇸
Modesto, California, United States
North Colorado Medical Center
🇺🇸
Greeley, Colorado, United States
McKee Medical Center
🇺🇸
Loveland, Colorado, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
🇺🇸
Farmington, Connecticut, United States
New Britain General Hospital
🇺🇸
New Britain, Connecticut, United States
Yale Comprehensive Cancer Center at Yale University School of Medicine
🇺🇸
New Haven, Connecticut, United States
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Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States