Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Periampullary Adenocarcinoma
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Phase 2

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: Phase II Study to Evaluate Stereotactic Body Radiation Therapy For Palliative Management of Unresectable Recurrent or Residual Pancreatic or Periampullary Adenocarcinoma Adenocarcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Late GI toxicity [ Time Frame: greater than 3 months after treatment ] [ Designated as safety issue: Yes ]
    grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity


Secondary Outcome Measures:
  • Acute GI toxicity [ Time Frame: within 3 months of treatment ] [ Designated as safety issue: Yes ]
    Any gastrointestinal (GI) toxicities grade 3 or greater.

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

  • Linac based SBRT pain control [ Time Frame: 3, 6, and 12 months after treatment ] [ Designated as safety issue: No ]
    To evaluate the ability of Linac based SBRT to provide pain control among symptomatic patients as measured by pain medication requirement at 3, 6 and 12 months after treatment.

  • FDG-PET use for planning and estimation of survival [ Time Frame: 3, 6, and 12 months after treatment and then annually thereafter ] [ Designated as safety issue: Yes ]
    To evaluate the utility of FDG-PET for treatment planning and estimation of progression-free survival.

  • Linac based SBRT standardization [ Time Frame: 3, 6, and 12 months after treatment ] [ Designated as safety issue: No ]
    To develop and standardize Linac based SBRT delivery and dosimetric parameters

  • Toxicity and outcomes for patients with chemotherapy, with or without surgery and radiation for tumor assessments [ Time Frame: 3, 6, and 12 months after treatment and then annually thereafter ] [ Designated as safety issue: Yes ]
    To evaluate toxicity and outcomes among patients with recurrent or residual disease after previous chemoradiation therapy, with or without surgery, who will be treated with 5 Gy x 5.

  • Toxicity and outcomes for chemotherapy only and radiation [ Time Frame: 3, 6, and 12 months after treatment and then annually thereafter ] [ Designated as safety issue: Yes ]
    To evaluate toxicity and outcomes among patients with recurrent or residual disease after chemotherapy only, (with or without surgery), who will be treated with 6.6 Gy x 5.

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


Estimated Enrollment: 120
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 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.

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Christopher Wolfgang, M.D., Ph.D.         
Sub-Investigator: Luis Diaz, M.D.         
Sub-Investigator: Daniel Laheru, M.D.         
Sub-Investigator: Dung Le, M.D.         
Sub-Investigator: Elizabeth Jaffee, M.D.         
Sub-Investigator: Susannah Ellsworth, M.D.         
Sub-Investigator: Fariba Asrari, M.D.         
Sub-Investigator: John Cameron, M.D.         
Sub-Investigator: David Cosgrove, M.D.         
Sub-Investigator: Ralph Hruban, M.D.         
Sub-Investigator: Lei Zheng, M.D., Ph.D.         
Sub-Investigator: Martin Makary, M.D.         
Sub-Investigator: Matthew Weiss, 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: August 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
recurrent
unresectable
residual
stereotactic body radiation therapy (SBRT)
palliative management

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

ClinicalTrials.gov processed this record on October 02, 2014