Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	18 and over	NCI	ECOG-E4201 RTOG-ECOG-E4201, E4201, NCT00057876

Special Category: CTSU trial

Objectives

1. Compare the progression-free and overall survival of patients with locally advanced, unresectable pancreatic cancer treated with gemcitabine with or without radiotherapy.
2. Compare the objective response rate in patients treated with these regimens.
3. Compare the toxicity of these regimens in these patients.
4. Compare the quality of life (QOL) of patients treated with these regimens.
5. Determine the effect of gemcitabine and radiotherapy on the QOL of patients with improved objective response rate and progression-free and overall survival.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Locally advanced or regional (encompassable within the same radiotherapy portals) disease
  • No M1 disease
  • Adenosquamous cancers are allowed



• The following cellular types are not allowed:
  • Small cell
  • Mucinous cystadenocarcinoma
  • Islet cell
  • Papillary cystic neoplasms



• Unresectable disease, defined as a tumor causing superior mesenteric vein or portal vein occlusion OR superior mesenteric artery or hepatic artery encasement



• Must not be a candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0)



• Measurable and/or nonmeasurable disease by CT scan or MRI

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for pancreatic cancer

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy
• No concurrent intensity modulated radiotherapy

Surgery

• See Disease Characteristics

Other

• More than 4 weeks since prior investigational agents

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute granulocyte count at least 2,000/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or cholangitis)
• AST less than 5 times upper limit of normal (ULN)
• Albumin greater than 2.5 g/dL

Renal

• Creatinine no greater than 1.5 times ULN

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Willing and able to attend follow-up visits
• Concurrent enrollment on protocol ECOG-E1Y03 allowed
• No active infection within the past 4 weeks
• No other 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)
• No history of active collagen vascular disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma)
• No signs or symptoms of peptic or duodenal ulcer disease
• No concurrent serious systemic disorders that are incompatible with study participation

Expected Enrollment

Approximately 332 patients will be accrued for this study within 2 years.

Outcomes

Overall survival at 13, 20, 26, and 36 months

Objective response rate
Progression-free survival
Toxicity as measured by NCI CTC v2.0
Quality of life as measured by Functional Assessment of Cancer Treatment-Hepatobiliary Symptom Index at baseline, 6, 15, and 16 weeks, and at 9 months

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 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.

Loehrer PJ, Powell ME, Cardenes HR, et al.: A randomized phase III study of gemcitabine in combination with radiation therapy versus gemcitabine alone in patients with localized, unresectable pancreatic cancer: E4201. [Abstract] J Clin Oncol 26 (Suppl 15): A-4506, 2008.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Patrick Loehrer, MD, Protocol chair		Ph: 317-278-7418; 888-600-4822

Radiation Therapy Oncology Group

Christopher Crane, MD, Protocol chair		Ph: 713-563-2340; 800-392-1611

Registry Information
Official Title		A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer
Trial Start Date		2003-04-10
Trial Completion Date		2009-05-18
Registered in ClinicalTrials.gov		NCT00057876
Date Submitted to PDQ		2003-01-21
Information Last Verified		2006-01-04
NCI Grant/Contract Number		CA21115

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