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WBRT With Hippocampal-avoidance Technique Followed by SRT for Extensive-stage SCLC With Baseline Brain Metastases

ConditionsSCLC,Extensive StageBrain Metastases
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

This study aims to evaluate the safety and efficacy of hippocampal-sparing WBRT combined with SRS as first-line treatment for SCLC patients with brain metastases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group(ECOG) performance status score 0-2;

Small cell lung cancer confirmed by histopathology or cytology;

Complete baseline imaging data (including brain enhanced MRI/CT, positron emission tomography(PET/CT) or chest enhanced CT+ bone scan + neck and abdomen B ultrasound /CT) should be obtained before first-line treatment;

Patients with initial diagnosis of ES-SCLC with brain metastases who planned to receive at least 4 cycles of standard platinum-based doublet chemotherapy combined with immunotherapy (PD-1 or PD-L1 monoclonal antibody) as first-line treatment, and who met the organ function requirements as judged by the investigator;

Disqualifiers

Patients with non-small cell lung cancer (NSCLC) components on baseline pathological examination;

Patients who had received any antitumor therapy prior to ES-SCLC diagnosis;

Patients with imaging evidence of leptomeningeal metastasis or suspected leptomeningeal metastasis with symptoms and signs;

patients unable to undergo contrast-enhanced MRI;

Trial design

Design model

Single group

Treatments tested in this trial

  • HA-WBRT plus SBRT

    Radiation

    hippocampal-avoidance whole brain radiotherapy (WBRT) followed by stereotactic body radiotherapy (SBRT)

Treatment groups

56 Participants
are divided into 1 treatment group
Group A: HA-WBRT with SRSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

dose-limiting toxicities rate

dose-limiting toxicities(DLTs) were assessed according to CTCAE 5.0 criteria and included the following three conditions, with the exception of asymptomatic biochemical abnormalities: (1) grade 3 toxicity lasting for more than 7 consecutive days; (2) Grade 4 toxicity excluding neutropenia and thrombocytopenia; (3) Treatment-related grade 5 adverse events could not be excluded.

Time frame
30 days since the final day of radiotherapy
2

1-year intracranial progression-free survival rate

1-year intracranial progression-free survival (iPFS) rate was defined as proportion of patients without intracranial disease progression or death at 1 year of follow-up

Time frame
one year

Secondary outcomes

1

overall survival

overall survival(OS) was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.

Time frame
one year
2

time to intracranial progression

Time to intracranial progression was defined as the time from enrollment for treatment to the observation of progression of intracranial disease.

Time frame
one year
3

Changes in learning and memory function

learning and memory function was assessed at 2, 4, 6, and 12 months from the first day of radiotherapy using the Hopkins Verbal Learning Test (HVLT-R)

Time frame
one year
4

processing speed and executive function

processing speed and executive function was assessed at 2, 4, 6, and 12 months from the first day of radiotherapy using the trail making test (TMT-Part A, to assess processing speed, and TMT-Part B, to assess executive function).

Time frame
one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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