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

NCT03808662 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 18-431
• Study Type: interventional
• Target: 107
• Locations: 2 countries
• Sites: 10

Brief 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

Keywords

SBRT; Stereotactic Body Radiotherapy; Non-hematology metatstatic cancer; non-CNS oligo-progressive disease; intracranial metastatic disease; Memorial Sloan Kettering Cancer Center; 18-431

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  To study if the addition of early SBRT to extra-cranial oligo-progressive metastatic disease could prolong PFS compared to no SBRT. PFS is defined as the time from randomization to disease progression or death.

  Up to 52 weeks after final participant is enrolled

Secondary Outcomes (1)

• Overall survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Study Arms (2)

Arm 1: Early Stereotactic Body Radiotherapy/SBRT

EXPERIMENTAL

SBRT to all oligoprogressive sites

Radiation: Sterotactic Body Radiotherapy/SBRT

Arm 2:Standard of Care

ACTIVE COMPARATOR

Drug: Standard of care

Interventions

Sterotactic Body Radiotherapy/SBRT RADIATION

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.

Arm 1: Early Stereotactic Body Radiotherapy/SBRT

Standard of care DRUG

Standard of care per physician discretion

Arm 2:Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Willing and able to provide informed consent
• Metastatic disease detected on imaging and histologically confirmed:
• Triple negative breast cancer TNBC (ER \<1%, PR \<1%, her-2-neu 0- 1+ by IHC or FISH-negative or as determined by MD discretion)
• OR NSCLC (without known EGFR mutation or ALK/ROS1 rearrangement)
• OR Other high-risk breast cancer (per physician's discretion) progressed on hormone or systemic therapy, regardless of ER/HER2 status
• OR NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations with disease progression on first-line tyrosine kinase inhibitor
• Note:
• Biopsy of metastasis prior to enrollment is per treating physician's discretion per standard of care. It is preferred but not required.
• These patients are selected for the study given the similar survival outcomes when given standard of care therapies
• Patient has received at least first-line prior treatment with systemic therapy (either cytotoxic or targeted, including maintenance therapies).
• Patients who received prior immunotherapy are allowed.
• Patients who had any prior radiation therapy near or overlapping with the oligoprogressive sites are allowed to enroll.
• Patients with the following medical conditions precluding them from participating in other systemic therapy or drug trials are allowed:
• active liver disease, including viral or other hepatitis, or cirrhosis

You may not qualify if:

• Pregnancy.
• Leptomeningeal disease.
• Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma.
• Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (10)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Fred Hutchinson Cancer Research Center (Data Analysis Only)

Seattle, Washington, 98109, United States

Location

Princess Margaret Hospital/Ontario Cancer Institute (Data Analysis Only)

Toronto, Ontario, Canada

Location

Related Publications (2)

• Tsai CJ, Yang JT, Shaverdian N, Patel J, Shepherd AF, Eng J, Guttmann D, Yeh R, Gelblum DY, Namakydoust A, Preeshagul I, Modi S, Seidman A, Traina T, Drullinsky P, Flynn J, Zhang Z, Rimner A, Gillespie EF, Gomez DR, Lee NY, Berger M, Robson ME, Reis-Filho JS, Riaz N, Rudin CM, Powell SN; CURB Study Group. Standard-of-care systemic therapy with or without stereotactic body radiotherapy in patients with oligoprogressive breast cancer or non-small-cell lung cancer (Consolidative Use of Radiotherapy to Block [CURB] oligoprogression): an open-label, randomised, controlled, phase 2 study. Lancet. 2024 Jan 13;403(10422):171-182. doi: 10.1016/S0140-6736(23)01857-3. Epub 2023 Dec 14.

  PMID: 38104577 DERIVED

• Lee J, Koom WS, Byun HK, Yang G, Kim MS, Park EJ, Ahn JB, Beom SH, Kim HS, Shin SJ, Kim K, Chang JS. Metastasis-Directed Radiotherapy for Oligoprogressive or Oligopersistent Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2022 Jun;21(2):e78-e86. doi: 10.1016/j.clcc.2021.10.009. Epub 2021 Nov 18.

  PMID: 34903471 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nadeem Riaz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 17, 2019
• Study Start: January 16, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (1); US (9)