ClinicalTrialsFinder
RecruitingPhase 3NCT06457906

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

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)

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

340 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Brain MetastasesStereotactic RadiotherapySmall Cell Lung CancerSRSWhole Brain RadiotherpayHippocampal-avoidance

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of radiation therapy for people with small cell lung cancer (SCLC) who have up to 10 brain metastases (spots where cancer has spread to the brain). The comparison is between precise, targeted radiation (SRS/SRT/Hypo-RT) versus whole-brain radiation that protects the memory centers (HA-WBRT). **You may be eligible if...** - You are between 18 and 80 years old - You have small cell lung cancer with no more than 10 brain metastases - You are in reasonably good functional health (ECOG 0–2 or Karnofsky score ≥ 70) - Your expected survival is more than 6 months **You may NOT be eligible if...** - You have more than 10 brain metastases - Your performance status or expected survival does not meet the criteria - Other conditions make radiation therapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTExperimental 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.

RADIATIONControled group (HA-WBRT)

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

Locations(1)

Nan Bi

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06457906

Related Trials

A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer

NCT0715517442 locations

Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases

NCT0355039186 locations

A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors

NCT0625726424 locations

Tissue Procurement and Natural History Study of People With Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Extrapulmonary Small Cell Cancer, Pulmonary Neuroendocrine Tumors, and Thymic Epithelial Tumors

NCT021461701 location

MeDex: No Perioperative Dexamethasone in Brain Metastases

NCT070445571 location