Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy

Recruiting at1 trial location

Overseen by Jinming Yu, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Shandong Cancer Hospital and Institute

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a prospective, open,multicenter, randomized controlled phase III clinical trial. In patients with LS-SCLC who achieve remission after first-line chemoradiotherapy, the efficacy and safety of PCI or MRI surveillance is evaluated and analyzed. PCI is performed in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. MRI surveillance alone (delaying radiation until the actual brain metastasis) may be not inferior to PCI.

Research Team

Jinming Yu, PhD

Principal Investigator

Shandong Cancer Hospital and Institute

Eligibility Criteria

Inclusion Criteria

Histological or cytological confirmation of LS-SCLC before first-line chemoradiotherapy (according to the staging system of the Veterans' Affairs Lung Study Group (VALSG), Appendix 2)；

Remission is achieved after first-line chemoradiotherapy (CR or PR determined by RECIST v1.1)；

Brain MRI examination should be performed to exclude metastatic lesions of brain parenchyma and meninges within four weeks before enrollment；

Treatment Details

Interventions

• MRI Surveillance (Procedure)
• Prophylactic Cranial Irradiation (Radiation)

Participant Groups

Group I: MRI Arm Experimental Treatment 1 Intervention

Patients undergo enhancement MRI examination every 3 months in first two years, and then performed every 6 months until the brain metastasis occur. Once brain metastases occur, brain radiotherapy and systemic treatment should be conducted with the follow-up observation of brain enhancement MRI continuing.

Group II: PCI Arm Active Control 2 Interventions

Patients received PCI (recommended hippocampal protection) within 6 weeks after first-line treatment, with a total dose of 25 Gy, 2.5 Gy each time, once a day, 5 times a week, a total of 10 times. Brain enhancement MRI examination is performed every 3 months in first two years, and then performed every 6 months until the brain metastasis occur.

Prophylactic Cranial Irradiation is already approved in Canada, Japan for the following indications:

Approved in Canada as Prophylactic Cranial Irradiation for:

• Small cell lung cancer
• Limited stage small cell lung cancer
• Extensive stage small cell lung cancer

Approved in Japan as Prophylactic Cranial Irradiation for:

• Small cell lung cancer
• Limited stage small cell lung cancer
• Extensive stage small cell lung cancer

Who Is Running the Clinical Trial?

Shandong Cancer Hospital and Institute

Lead Sponsor

Trials

125

Recruited

225,000+

Dr. Yuping Sun

Shandong Cancer Hospital and Institute

Chief Medical Officer since 2022

MD from Shandong Medical University

Prof. Yu

Shandong Cancer Hospital and Institute

Chief Executive Officer

MD from Shandong Medical University