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

Alternate Title

Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	ECOG-E1200 E1200, NCT00049348

Objectives

1. Compare the percentage of margin-free resections in patients with locally advanced, potentially resectable adenocarcinoma of the pancreas treated with gemcitabine and radiotherapy vs gemcitabine, fluorouracil, and cisplatin followed by radiotherapy and fluorouracil.
2. Compare the efficacy of these regimens, as measured by CT scan response, in these patients.
3. Compare the posttreatment fibrosis in resected specimens of patients treated with these regimens.
4. Compare the toxicity of these regimens in these patients.
5. Compare the duration of objective response in patients treated with these regimens.
6. Compare the disease-free and overall survival of patients treated with these regimens.
7. Compare the effect of these regimens and disease recurrence on CA 19-9 values in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the pancreas
  • No adenosquamous cancers or adenocarcinoma associated with cystic mucinous neoplasms
  • Locally advanced disease that is potentially resectable, previously explored and considered unresectable, or deemed to require preoperative treatment for other reasons
  • Primary cancer in the head, body, or tail of pancreas



• Measurable disease



• No 360 degree encirclement of the superior mesenteric artery, hepatic artery, or celiac axis



• No metastases by CT scan and laparoscopy (if prior surgery, only CT scan required)

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for this disease

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to pancreas

Surgery

• Not specified

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count greater than 2,000/mm³
• Platelet count greater than 100,000/mm³

Hepatic

• Bilirubin less than 2 mg/dL (unless secondary to bile duct blockage by tumor)
• Biliary obstruction by tumor requires biliary stent at least 9 French or biliary bypass before therapy

Renal

• Creatinine less than 1.7 mg/dL

  OR

• Creatinine clearance greater than 60 mL/min

Other

• No other malignancy within the past 3 years except nonmelanoma skin cancer
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 80-160 patients (40-80 per treatment arm) will be accrued for this study.

Outcomes

Percentage of margin-free resections produced by each program

Efficacy as measured by CT scan response
Post-treatment fibrosis in the resected specimens
Toxicity
Duration of objective response
Disease-free survival
Overall survival
Effect of therapy and recurrence on CA19-9 values

Outline

This is a randomized, multicenter study. Patients are stratified according to superior mesenteric vein (SMV)/portal vein (PV) occlusion (yes vs no), SMV/PV/superior mesenteric artery/hepatic artery abutment or narrowing (yes vs no), prior exploration (yes vs no), and whether deemed to require preoperative therapy due to other factors (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients receive gemcitabine IV over 50 minutes once weekly for 6 weeks during radiotherapy. Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy.

  Maintenance therapy (4-8 weeks after completion of surgery): Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.




• Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 5, 29, and 33; cisplatin IV over 60 minutes on days 1-5 and 29-33; and fluorouracil IV continuously on days 1-4 and 29-32. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily on days 6-15 and 34-43 and epoetin alfa SC weekly on weeks 1-9. After completion of chemotherapy, patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients receive fluorouracil IV continuously daily during radiotherapy. Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy.

  Maintenance therapy (4-8 weeks after completion of surgery): Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 2 years.

Landry JC, Catalano P, Hoffman J, et al.: ECOG 1200: a randomized phase II trial of gemcitabine plus radiotherapy vs gemcitabine, 5-fluorouracil and cisplatin followed by radiotherapy and 5-fluorouracil in patients with locally advanced, potentially resectable pancreatic adenocarcinoma. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2111, S272, 2006.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

John Parker Hoffman, MD, Protocol chair		Ph: 215-728-3518; 888-369-2427 Email: JP_Hoffman@fccc.edu

Registry Information
Official Title		A Randomized Phase II Study Of Gemcitabine Plus Radiotherapy Vs. Gemcitabine, 5-Fluorouracil And Cisplatin Followed By Radiotherapy And 5-Fluoraracil For Patients With Locally Advanced, Potentially Resectable Pancreatic Adenocarcinoma
Trial Start Date		2003-05-21
Trial Completion Date		2009-05-18
Registered in ClinicalTrials.gov		NCT00049348
Date Submitted to PDQ		2002-09-11
Information Last Verified		2005-06-11
NCI Grant/Contract Number		U10-CA21115

Back to Top