A Phase I Study Evaluating the Safety of Stereotactic Central Ablative Radiation Therapy (SCART) for Bulky Metastatic or Recurrent Cancer

Status unconfirmed · Phase 1

Conditions studied: Malignant Neoplasms

In brief

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 a single-arm phase I clinical trial. The primary endpoint of the study was to determine dose-limiting toxicities (DLT)s and the Maximum Tolerated Dose (MTD) of SCART to bulky metastatic or recurrent cancers.

Key facts

Study ID

NCT04881981

Run by

Baptist Health, Louisville

People needed

12

Starts

2021-06-05

Expected to finish

2022-05-05

Last updated by the study team

2021-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Innovative Cancer Institute — Miami, Florida, United States
• Baptist health — Corbin, Kentucky, United States
• University of Kentucky Morehead Cancer Treatment Center — Morehead, Kentucky, United States
• Foshan Chancheng Hospital — Foshan, Guangdong, China

Full record on ClinicalTrials.gov

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