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Chemotherapy and Radiation Following Pancreatic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00660270
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : April 23, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

To describe the overall survival and disease-free survival in pancreatic cancer patients treated with adjuvant chemoradiation with cisplatin, continuous infusion 5FU and interferon alpha followed by gemcitabine.

To describe the toxicities associated with adjuvant chemoradiation with cisplatin. 5FU and interferon alfa followed by gemcitabine in patients with pancreatic cancers.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: Pancreatic Surgery Radiation: Radiation therapy Drug: Cisplatin Drug: 5-FU Drug: Alpha-interferon Drug: Gemcitabine Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Adjuvant Chemoradiation Following Pancreatic Resection For Adenocarcinomas Of The Pancreas Using 3-D Conformal Radiation With Cisplatin, 5FU, And Alpha-Interferon As Radiosensitizing Agents Followed By Gemcitabine
Study Start Date : May 2002
Primary Completion Date : November 2006
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1

Surgery (pancreaticoduodenectomy, either standard or pylorus-preserving, with either standard or extended lymph node dissection, with or without portal vein resection) should occur at 8 weeks (plus or minus 2, not to exceed 10)

Radiation therapy will occur 8 weeks (plus or minus 2, not to exceed 10) postoperatively. Daily dose of 1.8 Gy five days per week. The first 45 Gy will be given to planning target volume 1. After 45 Gy, portals will be reduced to encompass planning target volume 2. The boost dose will be 5.4 Gy.

Cisplatin IV 25 mg/m2 on days 1, 8, 15, 22, 29, and 36 during radiation.

5-FU CIVI at 175 mg/m2/d on days 1-38 without interruption during radiation.

Alpha-interferon SQ 3,000,000 units on Mondays, Wednesdays, and Fridays during radiation therapy.

Gemcitabine IV 1000 mg/m2 4 weeks after conclusion of radiation (on a 3 weeks on/1 week off schedule) on days 71, 78, 85, 99, 106, and 113.

Procedure: Pancreatic Surgery Radiation: Radiation therapy Drug: Cisplatin
Other Names:
  • CDDP
  • Platin
Drug: 5-FU
Other Names:
  • Fluorouracil
  • Efudex
Drug: Alpha-interferon Drug: Gemcitabine
Other Name: Gemzar


Outcome Measures

Primary Outcome Measures :
  1. To describe the overall survival and disease-free survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To describe the toxicities associated with adjuvant chemoradiation with cisplatin, 5FU and interferon alfa followed by gemcitabine in patients with pancreatic cancers. [ Time Frame: Week 15 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Resected adenocarcinoma of the pancreas
  • ECOG performance status 0 or 1
  • No prior chemotherapy or radiation therapy for cancer within the last five years.
  • Prior history of other malignancies allowable, if stable or requiring no active therapy.
  • Absolute neutrophil count >/= 1,500/mm3, platelet count >/= 100,000/mm3, and hemoglobin >/= 9 g/dL.
  • Serum creatinine </= 2 mg/dL.
  • Serum bilirubin </= 3.0 mg/dL.
  • Serum transaminases ( SGOT and SGPT) </= 5-fold the institutional upper limits.
  • No co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.
  • Able to sign an informed consent.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660270


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63119
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: David Linehan, MD Washington University School of Medicine
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00660270     History of Changes
Other Study ID Numbers: 02-0307
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013

Keywords provided by Washington University School of Medicine:
Chemotherapy
Radiation

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Cisplatin
Interferons
Interferon-alpha
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs