Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

Study Overview
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Brief Summary
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The investigators are looking to see if a certain dose of stereotactic body radiation therapy (SBRT) may be a viable treatment option for recurrent or residual pancreatic or periampullary adenocarcinoma.

Detailed Description
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No standard treatment option has yet been established for patients with recurrent or residual disease after definitive treatment of pancreatic or periampullary cancers (duodenal, ampullary, bile duct). Linac based stereotactic body radiation therapy (SBRT) administered in 1-3 fractions has been shown to be an effective treatment option for patients with unresectable, locally advanced pancreatic adenocarcinoma, achieving local control rates of 84-92% at one year. Associated late gastrointestinal toxicity rates have been reported to be 22-25% at 1 year. We hypothesize that similarly excellent local control rates (80-90% at one year) with a reasonable rate of toxicity (≤20%) can be achieved using Linac based SBRT delivered as 5 Gy x 5 for patients with local failure (remaining disease) after previous treatment with conventional chemoradiation therapy (CRT) with or without surgery and as 6.6 Gy x 5 for radiation-naïve patients with local failure (remaining disease) after previous treatment with surgery and/or chemotherapy. The toxicities of note for this trial are grade 2 and greater gastritis, fistula, enteritis, ulcer, or any other grade 3 or greater gastrointestinal toxicity.

Official Title
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Phase II Study to Evaluate Stereotactic Body Radiation Therapy For Palliative Management of Unresectable Recurrent or Residual Pancreatic or Periampullary Adenocarcinoma Adenocarcinoma

Conditions
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Pancreatic Cancer, Periampullary Adenocarcinoma

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation Therapy (SBRT)
* Radiation: Stereotactic Body Radiation Therapy (SBRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Karnofsky Performance Status greater than or equal to 70% confirmed pancreatic or periampullary adenocarcinoma pancreatic or periampullary tumor less than 8.0 cm in greatest axial dimension Either: standard of care treatment for pancreatic cancer that included radiation therapy * patients may be receiving continued chemotherapy post initial CRT. or standard of care treatment for pancreatic cancer that did not include radiation therapy * patients must have attempted chemotherapy upon initial diagnosis acceptable organ and marrow function as determined by blood tests ability to understand and give consent must be a patient to be treated with SBRT only at Johns Hopkins Hospital life expectancy of greater than 3 months Exclusion Criteria: extensive metastatic disease performance status of less than 70 children are excluded form the study no uncontrolled intercurrent illness no concurrent malignancy other than melanoma pregnant or breast feeding women are excluded women who are not post-menopausal and have a positive pregnancy test life expectancy of less than 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RT naive<br> | Radiation: Stereotactic Body Radiation Therapy (SBRT)<br>* SBRT 6.6 Gy x 5 (over 1-2 weeks)*<br>* Other names: SBRT;|
| Active Comparator: Previous RT<br> | Radiation: Stereotactic Body Radiation Therapy (SBRT)<br>* SBRT 5 Gy x 5 (over 1-2 weeks)*<br>* Other names: SBRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late GI toxicity | grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity | greater than 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute GI toxicity | Any gastrointestinal (GI) toxicities grade 3 or greater. | within 3 months of treatment | 
| Local progression free survival | Local progression free survival rate at 3, 6, and 12 months.. | 3, 6, and 12 months after treatment | 
| Linac based SBRT pain control | To evaluate the ability of Linac based SBRT to provide pain control among symptomatic patients as measured by pain medication requirement at 3, 6 and 12 months after treatment. | 3, 6, and 12 months after treatment | 
| FDG-PET use for planning and estimation of survival | To evaluate the utility of FDG-PET for treatment planning and estimation of progression-free survival. | 3, 6, and 12 months after treatment and then annually thereafter | 
| Linac based SBRT standardization | To develop and standardize Linac based SBRT delivery and dosimetric parameters | 3, 6, and 12 months after treatment | 
| Toxicity and outcomes for patients with chemotherapy, with or without surgery and radiation for tumor assessments | To evaluate toxicity and outcomes among patients with recurrent or residual disease after previous chemoradiation therapy, with or without surgery, who will be treated with 5 Gy x 5. | 3, 6, and 12 months after treatment and then annually thereafter | 
| Toxicity and outcomes for chemotherapy only and radiation | To evaluate toxicity and outcomes among patients with recurrent or residual disease after chemotherapy only, (with or without surgery), who will be treated with 6.6 Gy x 5. | 3, 6, and 12 months after treatment and then annually thereafter | 
| Health related Quality of Life (QoL) | To evaluate health-related quality of life (QoL) before and after SBRT. | 3, 6 and 12 months after treatment then annually thereafter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent, unresectable, residual, stereotactic body radiation therapy (SBRT), palliative management