Clinical trial NCT01781728: Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma
Official title: Phase II Study to Evaluate Stereotactic Body Radiation Therapy For Palliative Management of Unresectable Recurrent or Residual Pancreatic or Periampullary Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Periampullary Adenocarcinoma
Keywords: recurrent
unresectable
residual
stereotactic body radiation therapy (SBRT)
palliative management
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized, controlled Phase 2 trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Late Gastrointestinal Toxicities
timeFrame: 3 months post-treatment to date of first progression or date of death, whichever comes first assessed up to 36 months
Secondary outcomes:
measure: Acute Gastrointestinal Toxicity
timeFrame: within 3 months of treatment
measure: Local Progression Free Survival From SBRT
timeFrame: From date of randomization until the date of first documented progression or death from any cause (up to 36 months).
measure: Local Progression Free Survival From Diagnosis
timeFrame: From date documented diagnosis to date of first documented local disease progression.
measure: Change in Patient Reported Quality of Life (PR-QOL) Assessment at Baseline (Pre-treatment) and 3 Months (Post-Treatment)
timeFrame: Baseline (Pre-SBRT) and at 3 months (Post-SBRT)
measure: Linac Based SBRT Pain Control
timeFrame: 3, 6, and 12 months after treatment
measure: Linac Based SBRT Standardization
timeFrame: 3, 6, and 12 months after treatment
measure: FDG-PET Use for Planning and Estimation of Survival
timeFrame: 3, 6, and 12 months after treatment and then annually thereafter
measure: Toxicity and Outcomes for Patients With Chemotherapy, With or Without Surgery and Radiation for Tumor Assessments
timeFrame: 3, 6, and 12 months after treatment and then annually thereafter
measure: Toxicity and Outcomes for Chemotherapy Only and Radiation
timeFrame: 3, 6, and 12 months after treatment and then annually thereafter
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Amol Narang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: