Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas

Study Overview
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Brief Summary
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The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having borderline resectable disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. It may be argued that intensification of local and regional therapy might 1.) Increase the share of patients able to undergo curative surgery and 2.) Improve the local disease control interval and extend survival for patients who remain unresectable. Therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).

Detailed Description
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Participants as part of this research study will receive Proton radiation over 6 weeks with oral chemotherapy (capecitabine) only taken on radiation days. In addition, If surgery is an option, then surgical resection will be performed at least 8 weeks after treatment with radiation and chemotherapy.

Official Title
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A Phase II Trial of Escalated Dose Proton Radiotherapy With Elective Nodal Irradiation and Concomitant Chemotherapy for Patients With Unresectable, Borderline Resectable or Medically Inoperable Pancreatic Adenocarcinoma

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Radiation: Proton Radiation
* Drug: Capecitabine
* Procedure: Surgical resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy proven unresectable adenocarcinoma of the pancreas. Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery. A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation, Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter. Required pretreatment laboratory parameters: Absolute granulocyte count (AGC/ANC) ≥ 1.8 thou/mm3 Platelet count ≥ 100,000/mm3 Bilirubin < 2 mg/dl ALT/SGPT < 3x upper limit of normal Creatinine < 3 mg/dl Exclusion Criteria: Evidence of distant metastasis. Prior surgical resection. Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the participant has been disease free for 5 years prior to registration. Active or untreated infection, Pregnant or breastfeeding women or subjects of child producing potential not willing to use medically acceptable contraception while on treatment and for at least 12 months thereafter. Previous Radiation to the abdomen.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proton Radiation with capecitabine<br>The following will be performed in this group: Proton Radiation Therapy with concomitant oral chemotherapy, capecitabine taken on radiation treatment days for 6 weeks. A surgical resection will be performed between 8 and 16 weeks if radiographic studies suggest operability. | Radiation: Proton Radiation<br>* Proton Radiation 40.50 Gy relative biological effectiveness (RBE) in 18 fractions to gross disease and elective nodal volume followed by a 22.50 Gy (RBE) in 10 fraction boost to gross disease. Total dose 63 Gy (RBE) in 28 fractions over 6 weeks.<br>* Other names: Proton Beam Radiation;Drug: Capecitabine<br>* Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.<br>* Other names: Xeloda;Procedure: Surgical resection<br>* Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival at 12 months after radiation therapy | The trial is designed to allow detection of an improvement in the 12 month overall survival rate to 75% compared to the expected historical rate of 50%. | Approximately 12 months after radiation therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical resection rate. | Increase share of marginally resectable and unresectable patients being converted to resectable. | 3 months following the completion of radiation therapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unresectable, Borderline resectable