ClinicalTrials.gov
ClinicalTrials.gov Menu

Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01781728
Recruitment Status : Recruiting
First Posted : February 1, 2013
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Late GI toxicity [ Time Frame: greater than 3 months after treatment ]
    grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity


Secondary Outcome Measures :
  1. Acute GI toxicity [ Time Frame: within 3 months of treatment ]
    Any gastrointestinal (GI) toxicities grade 3 or greater.

  2. Local progression free survival [ Time Frame: 3, 6, and 12 months after treatment ]
    Local progression free survival rate at 3, 6, and 12 months..

  3. Linac based SBRT pain control [ Time Frame: 3, 6, and 12 months after treatment ]
    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.

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

  5. Linac based SBRT standardization [ Time Frame: 3, 6, and 12 months after treatment ]
    To develop and standardize Linac based SBRT delivery and dosimetric parameters

  6. 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 ]
    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.

  7. Toxicity and outcomes for chemotherapy only and radiation [ Time Frame: 3, 6, and 12 months after treatment and then annually thereafter ]
    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.

  8. Health related Quality of Life (QoL) [ Time Frame: 3, 6 and 12 months after treatment then annually thereafter ]
    To evaluate health-related quality of life (QoL) before and after SBRT.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781728


Contacts
Contact: Amol Narang, M.D. 410-502-3823 anarang2@jhmi.edu
Contact: Ella-Mae Shupe, R.N. B.S.N 410-502-9243 eburke4@jhmi.edu

Locations
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Amol Narang, M.D.    410-502-3823    anarang2@jhmi.edu   
Contact: Ella-Mae Shupe, R.N. B.S.N    410-502-9243    eburke4@jhmi.edu   
Sub-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.         
Principal Investigator: Amol Narang, M.D.         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
Principal Investigator: Amol Narang, M.D. Johns Hopkins University

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01781728     History of Changes
Other Study ID Numbers: J1273
NA_00070233 ( Other Identifier: JHMIRB )
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

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

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