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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

ConditionLimited Stage Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Cancer Hospital and Institute

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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；

The ECOG PS score was 0~2；

Disqualifiers

Patients with extensive SCLC (Appendix 2)；

The subjects are confirmed to have brain or meningeal metastasis before they are randomly divided into groups；

During the 5 years before the start of the study, patients with malignant tumors other than SCLC, diseases with negligible risk of metastasis or death (such as expected 5-year OS > 90%) and malignant tumors expected to be cured (such as fully treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated by curable surgery, ductal carcinoma in situ treated by curable surgery)；

Previous head and neck radiation fields overlapped with PCI field；

Trial design

Design model

Parallel

Treatments tested in this trial

  • MRI Surveillance

    Other intervention

    Receive MRI surveillance

  • Prophylactic Cranial Irradiation

    Radiation

    Receive PCI

Treatment groups

534 Participants
are divided into 2 treatment groups
Group A: PCI ArmActive comparator 2 interventions
Group B: MRI ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival (OS)

To compare the efficacy of PCI and MRI surveillance in patients with LS-SCLC.

Time frame
From date of randomization until the date of death due to any cause, assessed up to 2 years.

Secondary outcomes

1

1-year overall survival rate (1y-OS%)

Rate of patients surviving at 1 year.

Time frame
1-year
2

3-year overall survival rate (3y-OS%)

Rate of patients surviving at 3 year.

Time frame
3-year
3

Progression-free survival (PFS)

Time frame
From the date of randomization until the date of the first onset of disease progression or the time to die of any cause, whichever occurs first, assessed up to 2 years.
4

Brain metastasis rate

To compare brain metastasis rate between the two arms.

Time frame
From the date of randomization until the date of occurrence of brain metastasis, assessed up to 2 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Cancer Hospital and Institute

Lead sponsor

Source ClinicalTrials.gov
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