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RECRUITING
NCT06457906
PHASE3

SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

This phase III trial compares the effect of stereotactic radiosurgery and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain.

Official title: SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in Patients With Small-Cell Lung Cancer: A Prospective, Randomized, Multicenter Phase III Trial (SHARP Trial)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

340

Start Date

2023-09-01

Completion Date

2028-02-28

Last Updated

2025-07-16

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Experimental group (SRS/SRT/Hypo-RT)

The prescription dose of SRS/SRT is 18-22Gy in 1 fraction, 27Gy in 3 fractions and 30Gy in 5 fractions. The prescription dose of Hypo-RT is 40Gy in 8 fraction. The prescription dose could be adjusted if lesions are located in brain stem when treat with SRS/SRT/Hypo-RT.

RADIATION

Controled group (HA-WBRT)

The prescription dose of HA-WBRT is 30Gy in 10 fraction.

Locations (1)

Nan Bi

Beijing, Beijing Municipality, China