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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

2019-11-11 17:49:41 | BioPortfolio

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.

Description

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.

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.

Study Design

Conditions

Extensive Stage Lung Small Cell Carcinoma

Intervention

Magnetic Resonance Imaging, Prophylactic Cranial Irradiation

Status

Not yet recruiting

Source

Southwest Oncology Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-11T17:49:41-0500

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Medical and Biotech [MESH] Definitions

The use of molecularly targeted imaging probes to localize and/or monitor biochemical and cellular processes via various imaging modalities that include RADIONUCLIDE IMAGING; ULTRASONOGRAPHY; MAGNETIC RESONANCE IMAGING; fluorescence imaging; and MICROSCOPY.

A technique applicable to the wide variety of substances which exhibit paramagnetism because of the magnetic moments of unpaired electrons. The spectra are useful for detection and identification, for determination of electron structure, for study of interactions between molecules, and for measurement of nuclear spins and moments. (From McGraw-Hill Encyclopedia of Science and Technology, 7th edition) Electron nuclear double resonance (ENDOR) spectroscopy is a variant of the technique which can give enhanced resolution. Electron spin resonance analysis can now be used in vivo, including imaging applications such as MAGNETIC RESONANCE IMAGING.

Spectroscopic method of measuring the magnetic moment of elementary particles such as atomic nuclei, protons or electrons. It is employed in clinical applications such as NMR Tomography (MAGNETIC RESONANCE IMAGING).

A type of MAGNETIC RESONANCE IMAGING that uses only one nuclear spin excitation per image and therefore can obtain images in a fraction of a second rather than the minutes required in traditional MRI techniques. It is used in a variety of medical and scientific applications.

The creation of a visual display of the inside of the entire body of a human or animal for the purposes of diagnostic evaluation. This is most commonly achieved by using MAGNETIC RESONANCE IMAGING; or POSITRON EMISSION TOMOGRAPHY.

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