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

August 8, 2012
August 11, 2014
January 2013
June 2017   (final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT01781728 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma
Phase II Study to Evaluate Stereotactic Body Radiation Therapy For Palliative Management of Unresectable Recurrent or Residual Pancreatic or Periampullary Adenocarcinoma Adenocarcinoma

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Pancreatic Cancer
  • Periampullary Adenocarcinoma
  • Radiation: Stereotactic Body Radiation Therapy (SBRT)
    SBRT 5 Gy x 5 (over 1-2 weeks)*
    Other Name: SBRT
  • Radiation: Stereotactic Body Radiation Therapy (SBRT)
    SBRT 6.6 Gy x 5 (over 1-2 weeks)*
    Other Name: SBRT
  • Active Comparator: RT naive
    Intervention: Radiation: Stereotactic Body Radiation Therapy (SBRT)
  • Active Comparator: Previous RT
    Intervention: Radiation: Stereotactic Body Radiation Therapy (SBRT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
June 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Joseph Herman, M.D. 410-502-3823 jherma15@jhmi.edu
Contact: Beth Griffith, R.N. 410-502-9243 bgriffit@jhmi.edu
United States
 
NCT01781728
J1273, NA_00070233
Yes
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Not Provided
Principal Investigator: Joseph Herman, M.D. Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP