RecruitingNot ApplicableNCT05651802

PCI and Brain MRI Follow-up vs Brain MRI Follow-up Alone in Limited-stage SCLC Patients

Prophylactic Cranial Irradiation and Brain MRI Follow-up Versus Brain MRI Follow-up Alone in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Complete Remission After Definitive Radio-chemotherapy: a Prospective Randomized Trial

Sponsor

Zhejiang Cancer Hospital

Enrollment

220 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Cancer Limited Stage

Summary

At present, prophylactic cranial irradiation (PCI) is part of standard care for patients with limited-stage small cell lung cancer (SCLC) who have achieved good response after definitive thoracic radiotherapy and chemotherapy. However, the value of PCI is being challenged in the era when MRI examination of brain has been popularized. The goal of this clinical study is to compare PCI and regular brain MRI follow-up (control arm) and regular brain MRI follow-up alone (study arm) in patients with limited-stage SCLC who have received definitive radiotherapy and chemotherapy and acheived complete remission (CR) of tumor. The main questions to answer are: 1. Whether the 2-year brain metastasis-free survival rate of the study group is not inferior to that of the control group. 2. The difference of 2-year overall survival rate between the control group and the study group. 3. Whether the patients in the study group have better overall quality of life than those in the control group. Participants will randomly receive either PCI and regular brain MRI follow-up or regular brain MRI follow-up alone.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches after treatment for limited-stage small cell lung cancer (SCLC): brain radiation (PCI) plus regular brain MRI monitoring versus brain MRI monitoring alone. It tests whether regular MRI alone is as good as preventive brain radiation at preventing brain recurrence. **You may be eligible if...** - You have small cell lung cancer confined to one side of the chest (limited stage), confirmed by biopsy - You are 18 or older in good health (Karnofsky score 80 or higher) - Your initial treatment (chemotherapy ± chest radiation) achieved a good response **You may NOT be eligible if...** - Your cancer has already spread to the brain or beyond the chest - Your performance status is poor - You have had prior brain radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONProphylactic cranial irradiation

Prophylactic cranial irradiation (PCI) is actually a habitual statement. It is a technique used to eliminate tiny metastatic lesions that have already existed in the brain, but can not be found by brain MRI and other inspection methods.

RADIATIONThoracic radiotherapy

Thoracic radiotherapy is a local treatment of tumors located in the chest using ionizing radiation.

DRUGChemotherapy

Chemotherapy is the abbreviation of chemical drug therapy. It is a treatment method that uses chemical drugs to prevent the proliferation, invasion and metastasis of cancer cells, and finally kill cancer cells.