Postoperative Proton Radiotherapy With Chemo for Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Radiation: Proton radiation; Drug: Gemcitabine

• Registration Number: NCT01553019
• Lead Sponsor: University of Florida

Brief Summary

The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy has on resected pancreatic cancer.

Detailed Description

Proton radiation with concomitant chemotherapy

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-21
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-01
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection
• Post resection CA19-9 tumor marker baseline

Exclusion Criteria

• Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the patient has been disease free for at least 5 years prior to study consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1- R(0) negative	Proton radiation	50.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
3- R(2) gross positive	Proton radiation	59.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
2- R(1) micro-positive	Proton radiation	54.00 cobalt gray equivalent(CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
3- R(2) gross positive	Gemcitabine	59.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
2- R(1) micro-positive	Gemcitabine	54.00 cobalt gray equivalent(CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
1- R(0) negative	Gemcitabine	50.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine

Primary Outcome Measures

Name	Time	Method
Radiation Toxicity	90 days after completion of RT	Assessment of acute/late severe (defined as grade 3-5) radiation toxicity at the completion of therapy. Acute toxicity will be defined to be toxicity occurring within 90 days from the start of radiation treatment, and late toxicity will be defined as toxicity occurring more than 90 days from the start of radiation treatment.

Secondary Outcome Measures

Name	Time	Method
Survival Rate	1 year after completion of RT	One year overall survival rate
Response rate via CA 19-9	Every 3 months for 2 years, then every 6 months for 3-5 years then annually thereafter

Trial Locations

Locations (2)

University of Florida Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States

Provision Proton Therapy Center; 🇺🇸 Knoxville, Tennessee, United States