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A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer

Phase 3
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer


- 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.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the pancreas

- Locally advanced or regional (encompassable within the same radiotherapy

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival Time

Outcome 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.

Outcome Time Frame:

assessed every 3 months for 2 years, then every 6 months for year 3

Safety Issue:


Principal Investigator

Patrick J. Loehrer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2003

Completion Date:

May 2009

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • Pancreatic Neoplasms



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