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

Launched by ZHEJIANG CANCER HOSPITAL · Dec 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different approaches for patients with limited-stage small cell lung cancer (SCLC) who have responded well to treatment. The researchers want to find out if adding a treatment called prophylactic cranial irradiation (PCI) to regular brain MRI follow-ups helps improve patients' chances of staying free from brain metastases (cancer spreading to the brain) compared to just having regular brain MRI follow-ups alone. They will also look at overall survival rates and the quality of life for patients in both groups.

To be eligible for this study, participants must be at least 18 years old and have a confirmed diagnosis of limited-stage SCLC. They should have received definitive treatment, including chemotherapy and radiation, and achieved complete remission of their tumor within the past 4-6 weeks. Participants will be randomly assigned to one of the two groups: one will receive PCI along with regular brain MRI follow-ups, while the other will only receive the MRI follow-ups. Throughout the trial, participants can expect regular check-ups and monitoring to assess their health and quality of life. The trial is currently recruiting participants and aims to provide important insights into the best care for patients with this type of lung cancer.

Gender

ALL

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.

Trial Officials