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Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung

NCT03808662 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2026-02-04

No results posted yet for this study

Summary

The purpose of this study is determine if receiving stereotactic body radiation(SBRT) when participants' metastatic tumors have just begun to grow increase the length of time before disease gets worse

Conditions

  • TNBC - Triple-Negative Breast Cancer
  • Triple Negative Breast Cancer
  • NSCLC
  • NSCLC Stage IV
  • Non Small Cell Lung Cancer
  • Non Small Cell Lung Cancer Metastatic
  • NSCLC Stage IV Without EGFR/ALK Mutation

Interventions

RADIATION

Sterotactic Body Radiotherapy/SBRT

In general, it is recommended using 9-10 Gy x 3 or 10 Gy x 5 fractions given every other day. Physicians should try to give the highest BED whenever possible while respecting normal tissue tolerance. All lesions are recommended to receive a biologically effective dose (BED) of 60 Gy or higher (BED10≥70), assuming α/β ratio of 10 and using the linear-quadratic model: BED = nd x \[1 + d/(α/β)\] where n is number of fractions and d is dose per fraction. Sometimes BED ≥80 Gy is preferred, with lower doses ≥50 Gy allowed at the discretion of the treating physician for concerns about normal tissue toxicity.

DRUG

Standard of care

Standard of care per physician discretion

Sponsors & Collaborators

Principal Investigators

  • Nadeem Riaz, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-16
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03808662 on ClinicalTrials.gov