Optimal Planning Target Volume With Stereotactic Radiosurgery

Status Completed

Clinical Trial Summary

The purpose of this study is to estimate the rate of local control at the treated site of the metastasis as a function of 1mm versus 3mm expansion about the gross tumor volume (GTV). Each lesion, not each patient will be ranndomized to either the 1mm or 3mm margin with 40 lesions randomized to each arm.

Clinical Trial Description

Stereotactic radiosurgery (SRS) is used either as definitive treatment alone or as a "boost" in combination with whole-brain radiotherapy (WBRT) for the treatment of brain metastases. To establish a target for SRS, the gross tumor volume (GTV) is typically defined as the contrast-enhancing volume on T1-weighted axial MRI images. In turn, the volume chosen for treatment (the planning target volume or PTV) is generated by expanding the GTV to account for microscopic extension of tumor beyond the MRI-visualized volume and deviations in patient positioning at the time of treatment., However, the optimal PTV in patients undergoing SRS of brain metastases has not been established.

This pilot randomized study of approximately 49 patients (representing a total of 80 brain lesions) should be sufficient to explore the effect of margin expansion around the GTV for brain metastases. The patients enrolled in this study will undergo radiosurgery to a planning treatment volume generated by expanding the GTV of each lesion by either a 1mm or 3mm margin. Each lesion, not each patient, will be randomized to receive either the 1mm or 3mm margin with 40 lesions randomized to each arm (a patient with multiple lesions potentially could have a lesion randomized to the 1mm arm and a different lesion randomized to the 3mm arm). The primary outcome of 12-month local recurrence and the secondary outcome of the rate of radionecrosis at the SRS treatment site will be lesion-specific outcomes. All other secondary outcomes will be patient-specific outcomes. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01017497
Study type	Interventional
Source	Duke University
Contact
Status	Completed
Phase	N/A
Start date	December 2009
Completion date	December 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05023434` - A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
Terminated	`NCT01902771` - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors	Phase 1
Completed	`NCT04114786` - 3D Printed Mask for GBM and Brain Mets	N/A
Recruiting	`NCT04367779` - Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
Recruiting	`NCT06058988` - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer	Phase 2
Completed	`NCT02911155` - Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
Completed	`NCT02852655` - A Pilot Surgical Trial To Evaluate Early Immunologic Pharmacodynamic Parameters For The PD-1 Checkpoint Inhibitor, Pembrolizumab (MK-3475), In Patients With Surgically Accessible Recurrent/Progressive Glioblastoma	Phase 1
Completed	`NCT01650922` - Molecular Genetic Studies of Childhood Brain Tumors and Blood Samples	N/A
Completed	`NCT00329589` - A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients	Phase 1
Completed	`NCT00505141` - Urban Environmental Exposures and Childhood Cancer	N/A
Completed	`NCT00504660` - 6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients	Phase 2
Completed	`NCT00979810` - Image-Guided Stereotactic Biopsy of High Grade Gliomas	N/A
Recruiting	`NCT04899908` - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases	Phase 2
Active, not recruiting	`NCT02851706` - Natural History of and Specimen Banking for People With Tumors of the Central Nervous System
Completed	`NCT02798406` - Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects	Phase 2
Completed	`NCT01012609` - External Beam Radiation Therapy and Cetuximab Followed by Irinotecan and Cetuximab for Children and Young Adults With Newly Diagnosed Diffuse Pontine Tumors and High-Grade Astrocytomas	Phase 2
Completed	`NCT00782756` - Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma	Phase 2
Terminated	`NCT03149575` - VAL-083 Phase 3 Study in Temozolomide-Avastin (Bevacizumab) Recurrent GBM	Phase 3
Completed	`NCT01974804` - Assessment of Early Treatment Response by Diffusion and Perfusion MRI in Patients With Brain Metastasis
Withdrawn	`NCT01320787` - 18-F-Fluoroacetate as PET Imaging Agent	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.