Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins48 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer Periampullary Adenocarcinoma

Interventions

Stereotactic Body Radiation Therapy (SBRT)RADIATION

Stereotactic Body Radiation Therapy (SBRT) which included 5 consecutive fractions of 25 to 33 Gy, following 3 months of multiagent chemotherapy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Late Gastrointestinal Toxicities

Late (Up to 3 months post-treatment to date of first progression or date of death, (whichever comes first-up to 36 months) Grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity attributable to Stereotactic Body Radiation Therapy (SBRT). Toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria.

Time frame: 3 months post-treatment to date of first progression or date of death, whichever comes first assessed up to 36 months

Secondary Outcomes

Acute Gastrointestinal Toxicity

Any acute gastrointestinal (GI) toxicities grade 3 or greater.

Time frame: within 3 months of treatment

Local Progression Free Survival From SBRT

Local progression free survival defined as the length of time (months) during and after the treatment of a disease that a patient lives with cancer, but the disease does not worsen.

Time frame: From date of randomization until the date of first documented progression or death from any cause (up to 36 months).

Local Progression Free Survival From Diagnosis

Local progression free survival defined as the length of time (months) during and after the treatment of a disease that a patient lives with cancer, but the disease does not worsen.

Time frame: From date documented diagnosis to date of first documented local disease progression.

Change in Patient Reported Quality of Life (PR-QOL) Assessment at Baseline (Pre-treatment) and 3 Months (Post-Treatment)

To evaluate whether a change in patient reported quality of life (QoL) occurred between baseline (pre-SBRT) and at 3 months (post-SBRT) using the European Organization for Research and Treatment in Cancer quality of life core cancer questionnaire with the pancreatic cancer module (EORTC QLQ-C30/Pan26). This assessment is a multi-dimensional, 30-item questionnaire which assesses 5 functional scales (physical, role, cognitive, emotional and social), 3 symptom scales ( fatigue, pain and nausea/vomiting), a global health/QoL scale as well as 6 single items. There are also 26 questions specific to patients with pancreatic cancer. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.

Data from ClinicalTrials.gov

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