Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: November 9, 2001
Last updated: September 26, 2013
Last verified: September 2013

RATIONALE: Drugs used in chemotherapy use 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. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced pancreatic cancer.

Condition Intervention Phase
Pancreatic Cancer
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 9 months up to 3 years post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: After 2 cycles of tx, then q 2 mon for 1 yr then q 3 mon for 2 yrs ] [ Designated as safety issue: No ]
  • Clinical Response [ Time Frame: q 2 mon for Yr 1 post Tx, then q 3 mon for 2 yrs ] [ Designated as safety issue: No ]
  • CA19-9 Levels [ Time Frame: q cycle, then q 2 mon for 1 yr, then q 3 mon for 2 yrs ] [ Designated as safety issue: No ]
    Biomarker response

  • Toxicity [ Time Frame: q cycle ] [ Designated as safety issue: Yes ]

Enrollment: 81
Study Start Date: September 2001
Study Completion Date: June 2010
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine + 5FU + XRT
Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer
Drug: fluorouracil
200mg/sq m/d CIVI 5/7 days during radiation therapy (wks 1-6)
Other Name: 5FU
Drug: gemcitabine hydrochloride
200mg/sq m IV infusion over 30 min wkly (on d 1, 2, OR 3) during radiation tx (wks 1-6) 1000mg/sq m IV infusion over 30 min wkly for 3 weeks during ea chemotherapy cycle
Radiation: radiation therapy
4500cGy total in 25 fractions M-F followed by 540cGy in 3 fractions (Total dose 5040cGy)during radiation tx (wks 1-6)

Detailed Description:


  • Determine the overall survival of patients with locally advanced non-metastatic pancreatic adenocarcinoma treated with gemcitabine, fluorouracil, and radiotherapy.
  • Determine the time to progression in patients treated with this regimen.
  • Determine the overall clinical response in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes once weekly and fluorouracil IV continuously on days 1-5 weekly for 6 weeks. Patients concurrently undergo radiotherapy 5 days a week for 6 weeks.

Three weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 24 months.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed pancreatic adenocarcinoma

    • Non-metastatic disease that is unresectable due to any of the following:

      • Tumor greater than 5 cm
      • Bulky lymph nodes greater than 2 cm, but within the radiation port
      • Vascular involvement or impingement of major vessels
      • Involvement of colon, adrenal glands, or kidney
  • Measurable or evaluable disease
  • No prior therapy for pancreatic adenocarcinoma
  • No peritoneal seeding or other evidence of metastatic disease by laparotomy or laparoscopy



  • 18 and over

Performance status:

  • CTC 0-2

Life expectancy:

  • Not specified


  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2.0 mg/dL
  • AST no greater than 3 times upper limit of normal


  • Creatinine no greater than 2.0 mg/dL


  • No myocardial infarction within the past 6 months


  • No other uncontrolled serious medical or psychiatric illness that would preclude study compliance
  • No other malignancy within the past 5 years except limited or curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • See Disease Characteristics


  • See Disease Characteristics

Endocrine therapy:

  • See Disease Characteristics


  • No prior abdominal radiotherapy


  • At least 2 weeks since prior major surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00026130

  Show 77 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Harvey J. Mamon, MD, PhD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Mamon HJ, Niedzwiecki D, Hollis DR, et al.: Preliminary analysis of Cancer and Leukemia Group B (CALGB) 80003: a phase II trial of gemcitabine, 5-fluorouracil (5FU), and radiation therapy (RT) in locally advanced non-metastatic pancreatic adenocarcinoma. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-22, S13, 2005.

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00026130     History of Changes
Other Study ID Numbers: CDR0000068988  U10CA031946  CALGB-80003 
Study First Received: November 9, 2001
Last Updated: September 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on April 27, 2016