A Phase II Trial of Postoperative Proton Radiotherapy With Concomitant Chemotherapy for Patients With Resected Pancreatic Adenocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- Proton radiation
- Conditions
- Pancreatic Cancer
- Sponsor
- University of Florida
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Radiation Toxicity
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
1- R(0) negative
50.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
Intervention: Proton radiation
1- R(0) negative
50.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
Intervention: Gemcitabine
2- R(1) micro-positive
54.00 cobalt gray equivalent(CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
Intervention: Proton radiation
2- R(1) micro-positive
54.00 cobalt gray equivalent(CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
Intervention: Gemcitabine
3- R(2) gross positive
59.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
Intervention: Proton radiation
3- R(2) gross positive
59.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
Intervention: Gemcitabine
Outcomes
Primary Outcomes
Radiation Toxicity
Time Frame: 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 Outcomes
- Survival Rate(1 year after completion of RT)
- Response rate via CA 19-9(Every 3 months for 2 years, then every 6 months for 3-5 years then annually thereafter)