Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT06457906

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

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-07-16

340

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 80 years with performance status 0-2 or Karnofsky score 70 or higher and expected lifetime over 6 months
  • Pathologically confirmed small cell lung cancer diagnosed within 5 years (or more recent confirmation if original diagnosis was over 5 years ago)
  • No more than 10 brain metastases, each 5 cm or smaller and 150 ml or less in treated volume, confirmed by MRI within 2 weeks before study
  • All brain metastases must be located outside a 5-mm margin around the hippocampus or optic pathways
  • Patients not suitable for surgical removal of all brain lesions; partial resection allowed if at least 2 weeks have passed since surgery
  • Ability to complete study assessments (cognitive tests, questionnaires) and follow-up for at least 6 months
  • At least one measurable brain metastasis according to RECIST 1.1 criteria
  • Women of childbearing potential and sexually active men willing to use contraception during treatment and for 180 days after
  • Written informed consent provided before enrollment
Not Eligible

You will not qualify if you...

  • Evidence of new, untreated, or progressing brain metastases before registration
  • Previous brain radiotherapy
  • Unable to tolerate immobilization or contraindications for MRI (e.g., pacemaker, defibrillator, certain implants)
  • Hydrocephalus, ventricular system distortion, leptomeningeal metastases, or increased intracranial pressure needing urgent surgery
  • Unrecovered severe toxicities (grade 3 or higher) from prior treatments
  • Serious illnesses such as recent heart attack, severe arrhythmia, or psychiatric disorders within past 6 months
  • Other active cancers diagnosed within 5 years requiring treatment (excluding certain skin and cervical cancers)
  • Pregnant or breastfeeding women
  • Participation in another clinical trial or competing study at the same time

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nan Bi

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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Research Team

N

Nan Bi, M.D

CONTACT

J

Jianyang Wang, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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