CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 340 target
Drug / intervention
Experimental group (SRS/SRT/Hypo-RT) +1 morecombination
Likely dose
Not stated in record
Key inclusion· 14
  • ✓Adult patients aged 18-80 years
  • ✓ECOG performance status 0-2 or Karnofsky ≥70
  • ✓Expected lifetime more than 6 months
  • ✓Pathologically proven small cell lung cancer within 5 years; recent confirmation required if original diagnosis >5 years ago
Key exclusion· 9
  • ✕Clinical or radiologic evidence of new, untreated, and/or progressive brain metastases prior to registration
  • ✕Previous radiotherapy of the brain
  • ✕Cannot tolerate immobilization or MRI contraindications (cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants)
  • ✕Radiographic evidence of hydrocephalus, ventricular system distortion, leptomeningeal metastases, or increased intracranial pressure requiring immediate decompression surgery

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06457906
NCT06457906Phase 3RecruitingOn TrackUpdated 11mo ago
CompareCT.gov

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)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences·interventional·Posted Jun 13, 2024·Updated Jul 16, 2025

In Brief

A Phase 3 clinical trial evaluating Experimental group (SRS/SRT/Hypo-RT) and Controled group (HA-WBRT) for Small-cell Lung Cancer and 5 related conditions. Currently recruiting, targeting 340 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall-cell Lung Cancer, Brain Metastases, SRS, Stereotactic Radiotherapy, Whole Brain Radiotherpay, Hippocampal-avoidance
CountriesChina
Collaborators--

Timeline

Phase 3Recruiting
20242025202620272028
First PostedJun 13, 2024
Enrollment StartSep 1, 2023
Primary CompletionAug 30, 2027
Study CompletionFeb 28, 2028
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 2.1 years agoPrimary completion in 1.2 years

Interventions

Experimental group (SRS/SRT/Hypo-RT)combination

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.

Controled group (HA-WBRT)radiation

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