NCT05651802 PCI and Brain MRI Follow-up vs Brain MRI Follow-up Alone in Limited-stage SCLC Patients
| NCT ID | NCT05651802 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhejiang Cancer Hospital |
| Condition | Small Cell Lung Cancer Limited Stage |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2023-01-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 Criteria
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.
Contact & Investigator
Xiao Hu, MD, PhD
PRINCIPAL INVESTIGATOR
Zhejiang Cancer Hospital
Frequently Asked Questions
Who can join the NCT05651802 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Small Cell Lung Cancer Limited Stage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05651802 currently recruiting?
Yes, NCT05651802 is actively recruiting participants. Contact the research team at huxiao@zjcc.org.cn for enrollment information.
Where is the NCT05651802 trial being conducted?
This trial is being conducted at Guangzhou, China, Hangzhou, China.
Who is sponsoring the NCT05651802 clinical trial?
NCT05651802 is sponsored by Zhejiang Cancer Hospital. The principal investigator is Xiao Hu, MD, PhD at Zhejiang Cancer Hospital. The trial plans to enroll 220 participants.
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