Chemotherapy and Radiation Following Pancreatic Surgery

NCT00660270 | Completed Phase 2

• 1 other identifier: 02-0307
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Chemotherapy; Radiation

Outcome Measures

Primary Outcomes (1)

• To describe the overall survival and disease-free survival

  2 years

Secondary Outcomes (1)

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

  Week 15

Study Arms (1)

Arm 1

EXPERIMENTAL

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; Drug: 5-FU; Drug: Alpha-interferon; Drug: Gemcitabine

Interventions

Pancreatic Surgery PROCEDURE

Arm 1

Radiation therapy RADIATION

Arm 1

Cisplatin DRUG

Also known as: CDDP, Platin

Arm 1

5-FU DRUG

Also known as: Fluorouracil, Efudex

Arm 1

Alpha-interferon DRUG

Arm 1

Gemcitabine DRUG

Also known as: Gemzar

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63119, United States

Location

Related Publications (1)

• Linehan DC, Tan MC, Strasberg SM, Drebin JA, Hawkins WG, Picus J, Myerson RJ, Malyapa RS, Hull M, Trinkaus K, Tan BR Jr. Adjuvant interferon-based chemoradiation followed by gemcitabine for resected pancreatic adenocarcinoma: a single-institution phase II study. Ann Surg. 2008 Aug;248(2):145-51. doi: 10.1097/SLA.0b013e318181e4e9.

  PMID: 18650621 DERIVED

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiotherapy; Cisplatin; Fluorouracil; Interferon-alpha; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Deoxycytidine; Cytidine; Pyrimidine Nucleosides

Study Officials

• David Linehan, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 17, 2008
• Study Start: May 1, 2002
• Primary Completion: November 1, 2006
• Study Completion: February 1, 2009
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

US (1)