Proton Radiation for Resectable Carcinoma of the Pancreas

A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00763516

Acronym

PC02

Enrollment

Registered

2008-10-01

Start date

2009-02-28

Completion date

2017-08-17

Last updated

2017-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer, Proton radiation, Chemotherapy, Xeloda, Gemzar, Resectable, Surgery

Brief summary

The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy and surgery has on you and your pancreatic cancer. This study will look at the side effects from the treatment and the quality of your life in relation to pain. It will also look at how the tumor responds to the combination of treatment with radiation, chemotherapy and surgery.

Detailed description

Chemotherapy capecitabine on radiation days Proton radiation over 6 weeks Surgery 6 weeks after radiation completion Adjuvant Chemotherapy starting 2-8 weeks after surgery with Gemzar

Interventions

RADIATIONProton radiation and chemotherapy

Neoadjuvant Chemotherapy Capecitabine (Xeloda®) 1,000 mg by mouth twice a day 5 days/week (M-F) on radiation days only Proton radiation 50.4 cobalt gray equivalent(CGE) in 28 fractions over 6 weeks Surgery: Gross total resection of primary tumor and regional lymph nodes done 6 weeks after completion of radiation Adjuvant Chemotherapy starting 2-8 weeks after surgery Suggested Regimen: Gemcitabine (Gemzar®) 1,000 mg/m2 IV total of 18 doses

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Pathologically confirmed adenocarcinoma of the pancreas. * Patients must have marginally resectable disease. * Patients with biliary obstruction must have adequate drainage prior to starting chemoradiation.

Exclusion criteria

* Evidence of distant metastasis including peritoneal seeding and/or ascites. * Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment. * Prior surgical resection. * Gastroduodenal obstruction

Design outcomes

Primary

Measure	Time frame
Cumulative incidence of grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ nonhematologic acute adverse events (occuring within 90 days of treatment start)	1 year following the completion of radiation therapy

Secondary

Measure	Time frame
Collect and analyze tumor control outcomes	1 year following the completion of radiation therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026