MedTrace Logo

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

NCT05651802 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2023-12-19

No results posted yet for this study

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.

Conditions

  • Small Cell Lung Cancer Limited Stage

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    collaborator OTHER

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Xiao Hu, MD, PhD · Zhejiang Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05651802 on ClinicalTrials.gov