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NRG-BN013 Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases

Clinical Trial Details

This study is being done to evaluate if a type of SRS radiation treatment called fractionated SRS (or FSRS) completed over 3 treatments to the areas of cancer in the brain delay the time until the cancer worsens or returns compared to the usual SRS given in 1 treatment.

Participants will be randomized into one of two treatment groups. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Group one will receive the usual SRS treatment and group two will receive FSRS. Image-Guided Radiation Therapy (IGRT) will be included no matter the group assignment.

After completing radiation treatment, participants will have follow-up visits in either the clinic or via telephone every 3 months for 1 year, then every 4 months for 1 year, and after 2 years, the study doctor will check in approximately every 6 months for the next 3 years.

Key Eligibility: 

1. Open to men and women above the age of 18 who have been diagnosed with one of the following malignancies
   • Non-small cell lung cancer
   • Melanoma
   • Breast Cancer
   • Renal cell carcinoma
   • Gastrointestinal cancer 
2. Participant must not have received prior radiotherapy to the brain, or have Leptomeningeal Disease (LMD) 

Detailed eligibility will be reviewed when contacting the study team.

Study contact by location

Queens

Contact(s)

Charlotte Fong
718-660-1716
ccf4001@med.cornell.edu

Brooklyn

Contact(s)

Roan Raymundo
929-470-9507
ror7059@med.cornell.edu

Protocol ID(s)

Weill Cornell Medicine IRB #:

2510029444

ClinicalTrials.gov:

NCT06500455

Sponsor:

NRG-BN013

Status

Not Yet Recruiting

Age Group

Adult

Sponsor