NCT03808662

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

Precision Radiation for OligoMetastatIc and MetaStatic DiseasE (PROMISE)-004: Consolidative Use of Radiotherapy to Block (CURB) Oligoprogression

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-01-16
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2019-01-17
• Last updated: 2026-02-04

Locations

10 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study