Radiotherapy With Chemotherapy as Neoadjuvant Therapy of Resectable and Borderline Resectable Pancreas Cancer

Phase II Trial of Accelerated Fraction Radiotherapy With Concomitant Capecitabine as Neoadjuvant Therapy of Resectable and Borderline Resectable Pancreas Cancer

The purpose of this study is to determine safety and to obtain preliminary estimates of the rate of major pathologic response of neoadjuvant accelerated fraction, standard dose radiation given with chemotherapy in patients with locally advanced pancreas cancer.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Capecitabine; Radiation: Standard Dose Acclerated Fraction Radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
      • Contact: Erin Yarde, MS; Phone Number: 434-243-8588; Email: ery7b@virginia.edu
      • Principal Investigator: Hanna K. Sanoff, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion:

1. Clinically staged I-III, pathologically confirmed adenocarcinoma of the pancreas. Mixed (e.g. adeno-squamous, neuroendocrine features) and/or poorly differentiated carcinomas are eligible as long as the carcinoma is not a predominantly neuroendocrine carcinoma. Cancers must be deemed by multidisciplinary assessment at UVA to be either

   • Resectable

     • No overt evidence of vascular involvement
     • No overt metastatic disease

   • Borderline Resectable, meeting one of the following categories:

     • Local tumor characteristics:

       • Abutment of <180◦ of the superior mesenteric artery and/or celiac axis
       • Abutment or encasement of a short segment hepatic artery
       • Involvement of the portal vein or superior mesenteric vein amenable to vascular reconstruction

     • Concern for extra pancreatic metastatic disease

       • indeterminant nodule on imaging
       • Pathologically confirmed N1
     • Borderline performance status or medical comorbidities as determined by investigators to be concerning for patient's ability to tolerate pancreatic resection
   • Patients with overtly unresectable disease are ineligible
2. No prior therapy for pancreatic cancer, including surgery, radiation, or chemotherapy
3. ≥18 years of age
4. Able to provide informed consent and comply with study procedures
5. Concurrent therapy with warfarin is permitted, but INR must be checked weekly
6. Concurrent therapy with phenytoin is permitted, but phenytoin levels must be checked weekly.
7. Concurrent therapy with CYP2C9 substrates is permitted but discouraged. Patients taking fluoxetine, glipizide, losartan, voriconazole, or other CYP2C9 substrates should consider switching to an alternative medication if feasible. (see Appendix 11.3 for a list of CYP2C9 substrates).

8. Adequate organ function:

   • Hematologic

     • ANC ≥ 1.5 x 10^9 cells/liter
     • Plts ≥ 100,000 x 10^9 cells/liter

   • Hepatic

     • Total bilirubin ≤ 5 fold the upper limits of normal for laboratory if due to biliary obstruction secondary to disease. For patients with total bilirubin 3-5 times the upper limit, attempt to relieve biliary obstruction is required
     • AST/ALT ≤ 5 fold the upper limits of normal for laboratory

   • Renal

     • Creatinine clearance as measured by Cockcroft-Gault (APPENDIX) of >30 mL/min.
     • Patients with creatinine clearance of 30-50 mL/min require 25% reduction of capecitabine dose.

Exclusion:

1. No pregnant or lactating women. Women of child bearing age must have a negative pregnancy test within seven days of beginning therapy and agree to use reliable contraception for the duration of the study period.
2. No comorbid condition which is deemed by the investigator to have a life expectancy of less than 6 months
3. No other malignancy diagnosed within the past 5 years, excepting all in situ cancers and invasive nonmelanomatous skin cancers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capecitabine, Radiation	Drug: Capecitabine; Capecitabine; Radiation: Standard Dose Acclerated Fraction Radiotherapy; Standard dose accelerated fraction radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the safety of neoadjuvant accelerated fraction standard dose radiotherapy to 50 Gy with concomitant capecitabine in patients with resectable and borderline resectable pancreas cancer.	2 years

Collaborators and Investigators

• Sponsor: University of Virginia

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: March 4, 2011
• First Submitted That Met QC Criteria: April 8, 2011
• First Posted (Estimate): April 11, 2011

Study Record Updates

• Last Update Posted (Estimate): April 11, 2011
• Last Update Submitted That Met QC Criteria: April 8, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Pancreas; Radiation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: 15050