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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00049348
First received: November 12, 2002
Last updated: November 12, 2010
Last verified: June 2005
  Purpose

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 before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens combining chemotherapy with radiation therapy in treating patients who are undergoing surgery for locally advanced pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Biological: epoetin alfa
Biological: filgrastim
Drug: cisplatin
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Percentage of margin-free resections produced by each program [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy as measured by CT scan response [ Designated as safety issue: No ]
  • Post-treatment fibrosis in the resected specimens [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Duration of objective response [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Effect of therapy and recurrence on CA19-9 values [ Designated as safety issue: No ]

Study Start Date: May 2003
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.
  • Compare the efficacy of these regimens, as measured by CT scan response, in these patients.
  • Compare the posttreatment fibrosis in resected specimens of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the duration of objective response in patients treated with these regimens.
  • Compare the disease-free and overall survival of patients treated with these regimens.
  • Compare the effect of these regimens and disease recurrence on CA 19-9 values in these patients.

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.

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

  Eligibility

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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049348

  Show 137 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: John Parker Hoffman, MD Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
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.

Responsible Party: Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00049348     History of Changes
Other Study ID Numbers: CDR0000258056, E1200
Study First Received: November 12, 2002
Last Updated: November 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Eastern Cooperative Oncology Group:
adenocarcinoma of the pancreas
stage II pancreatic cancer
stage III pancreatic cancer

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Cisplatin
Fluorouracil
Epoetin Alfa
Lenograstim
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Hematinics
Hematologic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antiviral Agents

ClinicalTrials.gov processed this record on April 21, 2014