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

NCT06243003 | Recruiting Phase 1

• 1 other identifier: SCLC-BRT
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SCLC,Extensive Stage; Brain Metastases

Keywords

whole brain radiotherapy (WBRT); stereotactic body radiotherapy (SBRT)

Outcome Measures

Primary Outcomes (2)

• 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.

  30 days since the final day of radiotherapy

• 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

  one year

Secondary Outcomes (4)

• overall survival

  one year

• time to intracranial progression

  one year

• Changes in learning and memory function

  one year

• processing speed and executive function

  one year

Study Arms (1)

HA-WBRT with SRS

EXPERIMENTAL

hippocampal-sparing WBRT combined with SRS will be used to treat SCLC patients with baseline brain metastases during standard first-line chemotherapy combined with immunotherapy.

Radiation: HA-WBRT plus SBRT

Interventions

HA-WBRT plus SBRT RADIATION

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

HA-WBRT with SRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• Symptomatic interstitial lung disease or active infectious/noninfectious pneumonia;
• Patients requiring long-term corticosteroid or immunosuppressive therapy;
• Patients who are allergic to PD-1 or PD-L1 monoclonal antibody immunotherapy or unable to receive immune maintenance therapy for other reasons;
• Lactating or pregnant women;
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

zhengfei zhu

CONTACT

+8618017312901; fuscczzf@163.com

Xiao Chu

CONTACT

+8618017317922; chuxiao@sibs.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: For ES-SCLC patients with baseline brain metastasis enrolled in this study, standard chemo-immunotherapy will be delivered every 3 weeks. Simulation for radiotherapy should be performed at baseline, and WBRT should be completed no later than the start of the third course of systemic treatment. The WBRT dose is 30Gy/10Fx. For patients without brain metastases within 1cm of the hippocampus, hippocampal avoidance technology should be employed. After WBRT, the treating physician will perform another simulation for subsequent SRS treatment to the brain lesions. SRS should be completed no later than the start of the fourth course of drug treatment. Specific SRS dose should be as follows: 16Gy for tumors with a diameter ≤ 2cm; 12Gy for tumors with a diameter of between 2cm and 3cm. WBRT and SRS should be performed during the interval between two systemic drug treatments, concurrent (on the same day) brain radiotherapy with chemo-immunotherapy treatment should be avoided.

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 5, 2024
• Study Start: January 15, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)