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

Small Cell Lung Cancer Limited Stage Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05651802
• Other study ID #: PCI+MRI vs. MRI
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 2026

Study information

• Verified date: December 2023
• Source: Zhejiang Cancer Hospital
• Contact: Xiao Hu, MD, PhD
• Phone: +86-571-88128172
• Email: huxiao[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically/cytologically proven diagnosis of SCLC.

• Age = 18 years.

• Karnofsky performance status ( KPS) =80.

• The limited-stage is defined as the tumor confined to one side of the chest, including ipsilateral hilar, bilateral mediastinum, and bilateral supraclavicular lymph nodes. (The definition of metastatic lymph nodes is that the short diameter = 1cm or PET-CT shows increased metabolism with SUV=2.5, or proved by mediastinoscopy/EBUS/TBNA biopsy. The thickness of pleural effusion on chest CT is less than 1cm (unless cytology proves to be malignant pleural effusion). According to 8th AJCC/UICC TNM staging system, it is the I-IIIC without intrapulmonary metastasis.

• Patients who have received definitive chest radiotherapy and chemotherapy and achieved complete remission of tumor within 4-6 weeks after the end of radio-chemotherapy (in accordance with the Response Evaluation Criteria in Solid Tumors v.1.1 including enhanced CT scan of chest and abdomen, enhanced brain MRI, bone scan and tumor markers).

• Good follow-up compliance;

• Fully understand this study, and voluntarily sign the informed consent form.

Exclusion Criteria:

• Patients with a history of malignant tumors (past or concurrent) within 5 years, excluding papillary thyroid cancer, non-malignant melanoma skin cancer and cervical carcinoma in situ.

• Patients who have received radical surgery (excluding biopsy).

• Patients with psychiatric history, pregnancy and lactation.

• Uncontrolled diabetes, hypertension, severe active infection.

• Patients with chronic diseases of central nervous system.

• Patients with contraindications of brain MRI examination.

• Other situations deemed unsuitable by the doctor in charge.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer Limited Stage
• Small Cell Lung Carcinoma

Intervention

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.
• 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

Country	Name	City	State
China	Sun Yat-sen University, Cancer Center	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital	First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year brain metastasis-free survival estimated with kaplan-Meier method	To test with a one-sided significance of 5% whether for the treatment of limited-stage SCLC patients, brain MRI follow-up alone is non-inferior in terms of 2-year brain metastasis-free survival compared to PCI and brain MRI follow-up. Participants were monitored for up to 2 years. The brain metastasis-free survival time is defined as the time between the date of the first treatment until the date of first documented diagnosis of brain metastasis or the date of death from any cause.	Up to 2 years
Secondary	2-year overall survival estimated with kaplan-Meier method	To compare 2-year overall survival between patients who receive brain MRI follow-up alone and those who receive both PCI and brain MRI follow-up, with kaplan-Meier estimates. Participants were monitored for up to 2 years. The overall survival time is defined as the time between the date of the first treatment until the date of death from any cause.	Up to 2 years
Secondary	Intra-cranial progressive patterns	To compare the intra-cranial progressive patterns between patients who receive brain MRI follow-up alone and those who receive both PCI and brain MRI follow-up within 2 years. Intra-cranial progression is evaluated via the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. In this study, Intra-cranial progressive disease is defined as the new lesions developed in the brain.	Up to 2 years