Radiotherapy With Chemotherapy As Neoadjuvant Therapy Of Resectable And Borderline Resectable Pancreas Cancer

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-03-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-04-08
First Submitted that Met QC Criteria 2011-04-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-04-11
First Posted (ESTIMATED) 2011-04-11	Results First Posted N/A	Last Verified 2011-04

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Capecitabine, Radiation

DRUG: Capecitabine

Capecitabine

RADIATION: Standard Dose Acclerated Fraction Radiotherapy

Standard dose accelerated fraction radiotherapy

Primary Outcome Measures	Measure Description	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Collaborators and Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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Resources

PatientS

Caregivers

Clinical Trial Record