Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

Johns Hopkins Medicine logo

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)

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)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems