Chemotherapy and Radiation Following Pancreatic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00660270
First received: April 11, 2008
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Pancreatic Cancer
Procedure: Pancreatic Surgery
Radiation: Radiation therapy
Drug: Cisplatin
Drug: 5-FU
Drug: Alpha-interferon
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To describe the overall survival and disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 53
Study Start Date: May 2002
Study Completion Date: February 2009
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Washington University School of Medicine

Additional 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
Study First Received: April 11, 2008
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

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
Interferon-alpha
Interferons
Gemcitabine
Fluorouracil
Cisplatin
Radiation-Sensitizing Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014