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RECRUITING
NCT05651802
NA

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

Sponsor: Zhejiang Cancer Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2023-01-01

Completion Date

2026-06

Last Updated

2023-12-19

Healthy Volunteers

No

Interventions

RADIATION

Prophylactic 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.

RADIATION

Thoracic radiotherapy

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

DRUG

Chemotherapy

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.

Locations (2)

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China