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

NCT05651802 | Recruiting DMC

• 1 other identifier: PCI+MRI vs. MRI
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief 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. 1.Whether the 2-year brain metastasis-free survival rate of the study group is not inferior to that of the control group.
2. 2.The difference of 2-year overall survival rate between the control group and the study group.
3. 3.Whether the patients in the study group have better overall quality of life than those in the control group.

Conditions

Small Cell Lung Cancer Limited Stage

Keywords

prophylactic cranial irradiation; brain MRI follow-up; prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 2-year overall survival estimated with kaplan-Meier method

  Up to 2 years

• Intra-cranial progressive patterns

  Up to 2 years

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Patients who are randomized to control arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive PCI and regular brain MRI follow-up.

Radiation: Prophylactic cranial irradiation; Radiation: Thoracic radiotherapy; Drug: Chemotherapy

Study arm

EXPERIMENTAL

Patients who are randomized to study arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive regular brain MRI follow-up alone.

Radiation: Thoracic radiotherapy; Drug: Chemotherapy

Interventions

Prophylactic cranial irradiation RADIATION

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.

Control arm

Thoracic radiotherapy RADIATION

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

Control arm; Study arm

Chemotherapy DRUG

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.

Control arm; Study arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead
• Sun Yat-sen University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (2)

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xiao Hu, MD, PhD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Hu, MD, PhD

CONTACT

+86-571-88128172; huxiao@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 15, 2022
• Study Start: January 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)