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
Study ID
NCT06457906
Phase
PHASE3
Status
Recruiting
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Conditions

  • Brain Metastases
  • Hippocampal-avoidance
  • SRS
  • Small-cell Lung Cancer
  • Stereotactic Radiotherapy
  • Whole Brain Radiotherpay

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Experimental group (SRS/SRT/Hypo-RT) — COMBINATION_PRODUCT
    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.

Study Details

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.

Key Dates

First listed
Jun 13, 2024
Start date
Sep 1, 2023
Status verified
Jul 2025
Primary completion
Aug 30, 2027
Completion
Feb 28, 2028

Study Design

Enrollment
340 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SRS/SRT/Hypo-RT group
    The patients in this group will receive local treatment for BM.
  • Active Comparator: HA-WBRT group
    The patients in this group will receive HA-WBRT.

Primary Outcome Measure

Cognitive function scores [ Time Frame: At 6 months after radiotherapy. ]

Central Contacts

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