Status:
UNKNOWN
A Phase I Study Evaluating the Safety of Stereotactic Central Ablative Radiation Therapy (SCART) for Bulky Metastatic or Recurrent Cancer
Lead Sponsor:
Baptist Health, Louisville
Collaborating Sponsors:
Drexel University
Innovative Institute
Conditions:
Malignant Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
We aim to evaluate the feasibility and toxicity of testing the tolerance and immunogenic effects of high-dose SCART radiotherapy in patients with bulky metastatic or recurrent cancer in the setting of...
Detailed Description
Despite advances in screening and surveillance, patients continue to present with both bulky primary and metastatic tumors. Some patients presented with recurrent bulky cancer in prior treated radiati...
Eligibility Criteria
Inclusion
- 1.1 Patients must have a history of histologically confirmed metastatic or recurrent cancers.
- 1.2 Patients must have measurable disease documented by CT and/or PET that is amenable for SCART radiation with the shortest axis of 3 cm or longer.
- 1.3 Patients must be 18 years of age or older, as this is not a pediatric protocol. There is no maximum age restriction.
- 1.4 Patients must have a life expectancy of at least 6 months in order for the study endpoints to be evaluable.
- 1.5 Patients must have a Zubrod/GOG performance status of 0 or 1.
- 1.6 Patients must have normal organ and marrow function as defined below: leukocyte\>3,000/m l absolute neutrophil count \>1,500/m l platelets \>100,000/m l bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT) 2.5 X institutional upper limit of normal Creatinine within normal institutional limits OR; Creatinine clearance \> 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- 1.7 Women of child-bearing potential will be asked to use adequate contraception.
- 1.8 Patients must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion
- 2.1 Women who are pregnant or breastfeeding will be excluded.
- 2.2 Patients must not have any co-morbidity with life expectancy ≤ 6 months, or any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- 2.3 Patients must not have active Crohn's disease or inflammatory bowel disease (IBD).
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Key Trial Info
Start Date :
June 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 5 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04881981
Start Date
June 5 2021
End Date
May 5 2022
Last Update
May 11 2021
Active Locations (4)
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1
Innovative Cancer Institute
Miami, Florida, United States, 33143
2
Baptist health
Corbin, Kentucky, United States, 40701
3
University of Kentucky Morehead Cancer Treatment Center
Morehead, Kentucky, United States, 40351
4
Foshan Chancheng Hospital
Foshan, Guangdong, China