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

NCT04881981 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-05-11

No results posted yet for this study

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 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.

Conditions

  • Malignant Neoplasms

Interventions

RADIATION

SCART radiation therapy

We will deliver high dose radiation therapy using SCART method. Beam energies of 6Mv will be used. The high dose SCART therapy will be delivered using LINAC systems, as available and appropriate for each patient. The treatment plan used for each patient will be based on an analysis of the volumetric dose including DVH analyses of the PTV and critical normal structures.

Sponsors & Collaborators

  • Drexel University

    collaborator OTHER

  • Innovative Institute

    collaborator UNKNOWN

  • University of Kentucky

    collaborator OTHER

  • Foshan Chancheng Hospital

    collaborator UNKNOWN

  • Baptist Health, Louisville

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-05
Primary Completion
2022-05-05
Completion
2022-05-05
FDA Device
Yes

Countries

  • United States
  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881981 on ClinicalTrials.gov