Palliative Stereotactic Radiation for Pancreatic or Adenocarcinoma

This study is currently recruiting participants.
Verified February 2013 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01781728
First received: August 8, 2012
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

The investigators are looking to see if a certain dose of stereotactic body radiation therapy (SBRT) may be a viable treatment option for patients previously treated patients with recurrent pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Pancreatic Adenocarcinoma
Periampullary Cancer
Periampullary Adenocarcinoma
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pilot Study To Evaluate Stereotactic Body Radiation Therapy For Palliative Management Of Unresectable, Locally Recurrent Pancreatic Or Periampullary Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • GI toxicity [ Time Frame: 1 year from treatment start ] [ Designated as safety issue: Yes ]
    Grade 2 or greater late gastritis, fistula, enteritis, ulcer, or late grade 3-4 gastrointestinal toxicity at one year


Secondary Outcome Measures:
  • Acute GI toxicity [ Time Frame: 1 year from start of treatment ] [ Designated as safety issue: Yes ]
    Acute grade 2 or greater gastritis, fistula, enteritis, or ulcer or any other grade 3-4 gastrointestinal toxicity within 3 months of treatment.

  • Local progression free survival [ Time Frame: 3, 6, and 12 months after start of treatment ] [ Designated as safety issue: Yes ]
    Local progression free survival rate at 3, 6, and 12 months..

  • Metastasis free and overall survival. [ Time Frame: 3, 6, and 12 months after start of treatment and then annually thereafter ] [ Designated as safety issue: Yes ]
    Metastasis free and overall survival

  • Tumor size imaging [ Time Frame: 3, 6, and 12 months after start of treatment and then annually thereafter ] [ Designated as safety issue: No ]
    Change in pancreatic or periampullary tumor volume with FDG-PET (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) compared to CT

  • Quality of Life (QoL) [ Time Frame: 3, 6, and 12 months after start of treatment ] [ Designated as safety issue: No ]
    Health-related quality of life (QoL) before and after SBRT.

  • Utility of FDG-PET/CT (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) for tumor assessments [ Time Frame: 3, 6, and 12 months after start of treatment ] [ Designated as safety issue: No ]
    Utility of FDG-PET/CT (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose)scans for assessment of tumor response and progression.


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RT naive Radiation: Stereotactic Body Radiation Therapy (SBRT)
SBRT 6.6 Gy x 5 (over 1-2 weeks)*
Other Name: SBRT
Active Comparator: Previous RT Radiation: Stereotactic Body Radiation Therapy (SBRT)
SBRT 5 Gy x 5 (over 1-2 weeks)*
Other Name: SBRT

Detailed Description:

No standard treatment option has yet been established for patients who develop locally progressive disease after definitive treatment of pancreatic cancer or periampullary cancers (duodenal, ampullary, bile duct) with standard of care or protocol combined modality therapy. 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. The investigators hypothesize that similarly excellent local control rates (80-90% at one year) with a reasonable rate of toxicity (≤ 20%) can be achieved using SBRT delivered as 5 Gy x 5 for patients with local failure 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 after previous treatment with surgery and/or chemotherapy. The toxicities of note for this trial are grade 2 and greater gastritis, fistula, enteritis, or ulcer and any grade 3-4 GI toxicity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Karnofsky Performance Status greater than 70%
  • confirmed adenocarcinoma of the pancreas
  • pancreatic pr periampullary tumor less than 8.0 cm in greatest axial dimension
  • Either:

    • standard of care treatment for pancreatic cancer that included radiation therapy or
    • standard of care treatment for pancreatic cancer that did not include radiation therapy
  • disease progression
  • normal blood values
  • ability to understand and give consent
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781728

Contacts
Contact: Joseph Herman, M.D. 410-502-3823 jherma15@jhmi.edu
Contact: Beth Griffith, R.N. 410-502-9243 bgriffit@jhmi.edu

Locations
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Joseph Herman, M.D.     410-502-3823     jherma15@jhmi.edu    
Contact: Beth Griffith, R.N.     410-502-9243     bgriffit@jhmi.edu    
Principal Investigator: Joseph Herman, M.D.            
Sub-Investigator: Ross Donehower, M.D.            
Sub-Investigator: Timnothy Pawlik, M.D.            
Sub-Investigator: Nilofer Azad, M.D.            
Sub-Investigator: Richard Schulick, M.D            
Sub-Investigator: Christopher Wolfgang, M.D.            
Sub-Investigator: Luis Diaz, M.D.            
Sub-Investigator: Daniel Laheru, M.D.            
Sub-Investigator: Barish Edil, M.D.            
Sub-Investigator: Dung Le, M.D.            
Sub-Investigator: Elizabeth Jaffee, M.D.            
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Joseph Herman, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01781728     History of Changes
Other Study ID Numbers: J1273, NA_00070233
Study First Received: August 8, 2012
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
recurrent
unresectable

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013