Comparing brain MRI follow-up with and without prophylactic cranial irradiation in small cell lung cancer patients
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
This study is testing whether adding a preventive brain treatment helps small cell lung cancer patients who are in remission live longer and stay free of brain tumors compared to just regular brain scans.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT05651802 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the effectiveness of prophylactic cranial irradiation (PCI) compared to regular brain MRI follow-up alone in patients with limited-stage small cell lung cancer (SCLC) who have achieved complete remission after definitive thoracic radiotherapy and chemotherapy. The study will assess whether the brain metastasis-free survival rate and overall survival rate differ between the two groups, as well as the quality of life of participants. By analyzing these outcomes, the study seeks to determine if PCI remains a necessary part of treatment in the current era of advanced MRI technology.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed limited-stage small cell lung cancer who have achieved complete remission after treatment.
Not a fit: Patients with advanced-stage small cell lung cancer or those who have not achieved complete remission may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help refine treatment protocols for small cell lung cancer, potentially reducing unnecessary radiation exposure for patients.
How similar studies have performed: While the use of MRI in monitoring brain metastasis is becoming more common, this specific comparison of PCI versus MRI follow-up alone is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- Sun Yat-sen University, Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Xiao Hu, MD, PhD — Zhejiang Cancer Hospital
- Study coordinator: Xiao Hu, MD, PhD
- Email: huxiao@zjcc.org.cn
- Phone: +86-571-88128172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.