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NCT06243003RecruitingPhase 1/2

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

A Phase I/II Study to Evaluate the Safety and Efficacy of Hippocampal-avoidance Whole Brain Radiotherapy Followed by Stereotactic Radiotherapy for Extensive-stage Small Cell Lung Cancer With Baseline Brain Metastases

Source: ClinicalTrials.gov · Last updated 7 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
56 (estimated)
First submitted
24 Jan 2024
Start date
15 Jan 2024
Primary completion date
31 Jul 2025
Lead sponsor
Fudan University
Diseases
Lung cancer
NCT number
NCT06243003

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 56
  • From 15 Jan 2024 to the primary completion date, 31 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who had received any antitumor therapy prior to ES-SCLC diagnosis;
  • Patients with severe symptoms of brain metastases requiring emergency surgery to reduce intracranial pressure;
  • Patients who could not complete immobilization for radiotherapy or tolerate radiotherapy;
  • Patients requiring long-term corticosteroid or immunosuppressive therapy;

Other illness

  • Patients with non-small cell lung cancer (NSCLC) components on baseline pathological examination;
  • Symptomatic interstitial lung disease or active infectious/noninfectious pneumonia;
  • Patients who are allergic to PD-1 or PD-L1 monoclonal antibody immunotherapy or unable to receive immune maintenance therapy for other reasons;
  • The patient had severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.
  • Medical examination or clinical findings or other uncontrollable conditions that the investigator considers may interfere with the results or increase the risk of treatment complications for the patient;
  • Patients with mental illness, substance abuse, or social problems that could affect adherence were excluded from enrollment after physician review.

Other

  • Patients with imaging evidence of leptomeningeal metastasis or suspected leptomeningeal metastasis with symptoms and signs;
  • patients unable to undergo contrast-enhanced MRI;
  • Lactating or pregnant women;

Who the study is looking for

  • 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;
  • Brain metastases assessed by contrast-enhanced MRI met the criteria for SRS (less than or equal to 10 brain metastases, maximum tumor volume less than 10ml, maximum tumor diameter less than 3cm, total tumor volume less than 15ml, and no evidence of leptomeningeal metastasis).
  • No history of other malignant tumors;
  • Male/female of childbearing age agreed to use contraception (surgical ligation or oral contraceptive/intrauterine device + condom) during the trial;
  • Life expectancy ≥3 months
  • Patients must be able to understand and voluntarily sign informed consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.