Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

NCT01781728 | Completed Phase 2 Results DMC

• 2 other identifiers: J1273NA_00070233
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Periampullary Adenocarcinoma

Keywords

recurrent; unresectable; residual; stereotactic body radiation therapy (SBRT); palliative management

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (9)

• Acute Gastrointestinal Toxicity

  within 3 months of treatment

• Local Progression Free Survival From SBRT

  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

  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)

  Baseline (Pre-SBRT) and at 3 months (Post-SBRT)

• Linear Accelerator (Linac) Based SBRT Pain Control

  3, 6, and 12 months after treatment

Study Arms (1)

Locally advanced pancreatic cancer or locally recurrent pancreatic ductal adenocarcinoma

EXPERIMENTAL

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

Radiation: Stereotactic Body Radiation Therapy (SBRT)

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.

Locally advanced pancreatic cancer or locally recurrent pancreatic ductal adenocarcinoma

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Recurrence

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Amol Narang
• Organization: Johns Hopkins University, Department of Radiation Oncology

anarang2@jhmi.edu

410-913-3559

Study Officials

• Amol Narang, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized, controlled Phase 2 trial

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: February 1, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2024
• Last Updated: July 20, 2025
• Results First Posted: October 10, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)