Clinical Trials (PDQ®) - National Cancer Institute

Page Options

	Quick Links


	Director's Corner Dictionary of Cancer Terms NCI Drug Dictionary Funding Opportunities NCI Publications Advisory Boards and Groups Science Serving People Español

Questions about cancer?


	1-800-4-CANCER

	LiveHelp online chat

	NCI Highlights


	Maintenance Rituximab for Follicular Lymphoma Azacitidine Improves Survival in MDS Second Stem Cell Transplant Not Helpful in Myeloma

Phase III Radiotherapy with vs without Radiation Sensitizers (5-FU/MITO) for Locally Unresectable Stage I/II/III Pancreatic Carcinoma

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Closed any age NCI EST-8282

Objectives

I.  Test the feasibility and efficacy (relapse-free survival rates, length of 
remission, relapse patterns, survival) of radiation with or without radiation 
sensitizers (5-fluorouracil/mitomycin-C) as a therapeutic modality for 
unresected carcinoma of the pancreas.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients of any age with Stage I, II, 
or III pancreatic carcinoma or with biopsy-proven ductal adenocarcinoma Grades 
1-3, provided they have had an exploratory laparotomy.  Tumors must not be 
larger than 15 cm in any dimension.  The tumor must be unresectable.  Patients 
must have a performance status of 0, 1, or 2 and adequate bone marrow function 
and oral nutrition (at least 1,200 calories/day).  Prior abdominal 
radiotherapy and prior systemic therapy are not allowed.  Patients must be at 
least 10 days but no more than 6 weeks past major abdominal surgery.  The 
lesion should be outlined with clips if possible (relaparotomy to place clips 
is permissible).  Patients without clips are eligible provided the CT scan 
permits adequate tumor definition for precision high-dose radiotherapy.  
Patients with active infections, concurrent cancer (except skin cancer), or 
other disease processes that would prohibit protocol treatment are not 
eligible.

Expected Enrollment

A minimum of 105 evaluable patients is required.

Outline

Randomized study.
Arm I:  Radiotherapy.  Irradiation of the pancreas using megavoltage equipment.
Arm II:  Radiotherapy plus Sensitizers.  Pancreatic irradiation plus 
5-Fluorouracil, 5-FU, NSC-19893; Mitomycin-C, MITO, NSC-26980.

Published Results

Cohen SJ, Dobelbower R Jr, Lipsitz S, et al.: A randomized phase III study of radiotherapy alone or with 5-fluorouracil and mitomycin-C in patients with locally advanced adenocarcinoma of the pancreas: Eastern Cooperative Oncology Group study E8282. Int J Radiat Oncol Biol Phys 62 (5): 1345-50, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Ralph Dobelbower, MD, PhD, FACRO, FACR, Protocol chair
Ph: 419-383-5114
Email: rdobelbower@mco.edu

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.