Clinical trial NCT01358058: Proton Radiation Therapy for Gliomas
Official title: Phase II Study of Proton Radiation Therapy for Low Grade and Favorable Grade 3 Gliomas
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Grade Glioma
WHO Grade 3 Glioma With IDH1 Mutation
WHO Grade 3 Glioma With 1p/19q Codeletion
Keywords: Brain tumors
Radiation
Proton
Gliomas
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-05-23
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy
timeFrame: 7 years
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: 7 years
measure: Overall survival
timeFrame: 7 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Helen A Shih, MD
role: PRINCIPAL_INVESTIGATOR
References: