Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

Johns Hopkins Medicine

Status and phase: Active, not recruiting; Phase 2

Conditions: Periampullary Adenocarcinoma; Pancreatic Cancer

Treatments: Radiation: Stereotactic Body Radiation Therapy (SBRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01781728

NA_00070233 (Other Identifier)

J1273

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

RT naive

Active Comparator group

Treatment:

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Previous RT

Active Comparator group

Treatment:

Radiation: Stereotactic Body Radiation Therapy (SBRT)