Palliative Stereotactic Radiation for Pancreatic or Adenocarcinoma
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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 |
- 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
- 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 |
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| Contact: Joseph Herman, M.D. | 410-502-3823 | jherma15@jhmi.edu |
| Contact: Beth Griffith, R.N. | 410-502-9243 | bgriffit@jhmi.edu |
| 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. | |
| 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