Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

NCT ID: NCT01781728

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2024-06-01

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.

Conditions

Pancreatic Cancer; Periampullary Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Locally advanced pancreatic cancer or locally recurrent pancreatic ductal adenocarcinoma

Patients with pathologically confirmed, locally advanced pancreatic ductal adenocarcinoma (LAPC), unresectable at diagnosis, or local recurrence pancreatic ductal adenocarcinoma (PDAC) after prior surgical resection.

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: RADIATION

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

Interventions

Stereotactic Body Radiation Therapy (SBRT)

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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amol Narang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NA_00070233

Identifier Type: OTHER

Identifier Source: secondary_id

J1273

Identifier Type: -

Identifier Source: org_study_id