Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01358058
Other study ID # 10-439
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 2011
Est. completion date November 2025

Study information

Verified date March 2024
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this research study the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects that patients would normally experience with conventional radiation therapy. In this research study the investigators are looking to determine if proton radiation with a reduced field size will be as effective in controlling tumor growth as photon therapy, while reducing the treatment-related side effects observed in patients with brain tumors.


Description:

Proton radiation will be delivered daily for approximately 6 weeks. Subjects will be assessed weekly for side effects. Each visit will take about 15 minutes. Subjects will have follow-up visits at 3, 6, 12, 24, 36, 48, 60, 72, and 84 months after their last proton radiation treatment. They will receive a physical exam, MRI, have blood tests (about 4 teaspoons) and answer questionnaires regarding medical history, quality of life, and emotional well-being. Subjects will also receive a neurocognitive exam annually.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 63
Est. completion date November 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically confirmed low-grade gliomas OR Grade III anaplastic glioma with either or both IDH1 mutation or 1p/19q codeletion - Subject must be indicated for radiation therapy - Life expectancy greater than 5 years - Willing to participate in rigorous neurocognitive evaluations at baseline and serially following treatment - Able to speak and comprehend English - Recovered from adverse events due to agents administered more than 4 weeks before entering study - Able to undergo MRI scans Exclusion Criteria: - Prior cranial radiation therapy - Chemotherapy within 4 weeks prior to entering study - Pregnant or breastfeeding - Known brain metastases - Baseline neurocognitive or emotional disorders - Uncontrolled intercurrent illness - History of a different malignancy unless disease-free for at least 5 years - HIV positive on antiretroviral therapy

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Proton radiation
Total dose of 54-59.4 Gy(RBE) at 1.8 Gy(RBE) per daily fraction delivered 5 days per week on weekdays for 6-6.5 weeks.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy To assess progression free survival of this treatment program. 7 years
Secondary Safety and Tolerability To assess the number of participants with late effects from radiation therapy 7 years
Secondary Overall survival To assess overall survival of this treatment program. 7 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03233204 - Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial) Phase 2
Completed NCT04044937 - Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms Phase 2
Terminated NCT01452854 - Ovarian Aging in Low Grade Glioma (LGG) Treated With Temozolomide
Recruiting NCT03952598 - Studying the Biology of IDH-mutant Gliomas Via Longitudinal Observation of 2-hydroxyglutarate (2-HG) Using MR Spectroscopy N/A
Active, not recruiting NCT03213665 - Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Recruiting NCT05964569 - Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma Phase 2
Completed NCT02607397 - ROCOCO - Low Grade Glioma - Planning Study N/A
Recruiting NCT03718767 - Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype Phase 2
Recruiting NCT02455245 - A Study Comparing Two Carboplatin Containing Regimens for Children and Young Adults With Previously Untreated Low Grade Glioma Phase 3
Completed NCT02186262 - Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas
Terminated NCT02023905 - Everolimus With and Without Temozolomide in Adult Low Grade Glioma Phase 2
Recruiting NCT01386450 - AZD6244 in Children With Low-Grade Gliomas Phase 1/Phase 2
Completed NCT02286531 - Evaluation de O-(2-[18F]-Fluoroethyl)-L-Tyrosine, a New Tracer PET, in the Diagnosis of Low Grade Glioma N/A
Active, not recruiting NCT04553757 - Seizure Control as a New Metric in Assessing Efficacy of Tumor Treatment in Patients With Low Grade Glioma
Not yet recruiting NCT06132685 - Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial Phase 2
Recruiting NCT04166409 - A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma Phase 3
Recruiting NCT02358187 - A Vaccine Trial for Low Grade Gliomas Phase 2
Recruiting NCT03871257 - A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma Phase 3
Terminated NCT01281982 - (11C)dLop as a Marker of P-Glycoprotein Function in Patients With Gliomas
Active, not recruiting NCT01288235 - Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation Phase 2