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Testing Whether the Use of Brain Scans Alone Instead of Brain Scans plus Preventive Brain Radiation Affects Lifespan in Patients with Small Cell Lung Cancer

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT04155034
Protocol IDs
S1827 (primary)
NCI-2019-05338
S1827
Study Sponsor
SWOG
NCI Full Details
http://clinicaltrials.gov/show/NCT04155034

Summary

This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain 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. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.

Objectives

PRIMARY OBJECTIVE:
I. To evaluate whether overall survival (OS) with magnetic resonance imaging (MRI) surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).

SECONDARY OBJECTIVES:
I. To compare cognitive failure free survival (CFFS) rate up to 12 months after randomization between the arms.
II. To compare brain-metastasis-free survival between the arms.
III. To compare OS between the arms within the subgroups of patients with limited-stage and extensive-stage disease.
IV. To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms.
V. To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms.
VI. To compare the frequency and severity of toxicities between the two arms.

ADDITIONAL OBJECTIVE:
I. To collect blood for banking.
II. To collect brain MRIs for National Cancer Institute (NCI) approved MRI Imaging Ancillary Study.

HEALTH-RELATED QUALITY OF LIFE OBJECTIVES:
I.To compare patient-reported cognitive functioning between arms at 6 months from randomization using the cognitive factor score of the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT).
II. To compare patient-reported cognitive functioning between arms at 6 months from randomization using the Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form 4A.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo conventional or hippocampal avoidance PCI over 20 minutes 5 days per week for 2 weeks. Patients also undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.

ARM II: Patients undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.

Patients undergo computed tomography (CT) scan, positron emission tomography (PET) scan and blood sample collection throughout the study.
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