Phase 2
N=48
Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma
Pancreatic Cancer · Periampullary Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01781728 ↗Enrolled (actual)
48
Serious AEs
20.8%
Results posted
Oct 2024
Primary outcome: Primary: Late Gastrointestinal Toxicities — 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Stereotactic Body Radiation Therapy (SBRT) (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Late Gastrointestinal Toxicities |
13 | — |
| SECONDARY Acute Gastrointestinal Toxicity |
3 | — |
| SECONDARY Local Progression Free Survival From SBRT |
14.6 | — |
| SECONDARY Local Progression Free Survival From Diagnosis |
21.6 | — |
| SECONDARY Change in Patient Reported Quality of Life (PR-QOL) Assessment at Baseline (Pre-treatment) and 3 Months (Post-Treatment) |
— | — |
| SECONDARY Linear Accelerator (Linac) Based SBRT Pain Control |
— | — |
| SECONDARY Linac Based SBRT Standardization |
— | — |
| SECONDARY FDG-PET Use for Planning and Estimation of Survival |
— | — |
| SECONDARY Toxicity for Patients With Chemotherapy, Surgery (Resection) and Radiation for Tumor Assessments |
6 | — |
| SECONDARY Toxicity for Patients With Chemotherapy and Radiation (no Resection) |
7 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01781728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.