Phase II Study of Proton Radiation Therapy for Neuroblastoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT02112617
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Proton Beam Radiation Therapy — RADIATION
    Proton radiation will be delivered daily for 3-4 weeks, depending on the dose prescribed by study doctor. Treatment is delivered (Monday - Friday) for 5 days (no weekends or holidays). Each treatment the participant will lie on a table for 30-45 minutes.

Study Details

This research study is evaluating a therapy called proton beam radiation therapy (PBRT) as a possible treatment for neuroblastoma. Neuroblastoma most commonly occurs in and around the adrenal glands, which are located at the top of the kidneys. However, it can also occur in other areas where groups of nerve cells exist, such as other areas of the abdomen, neck and near the spine. Conventional radiation therapy with photons is used as standard treatment for many patients with neuroblastic tumors. In this research study, the investigators are looking at another type of radiation called proton radiation which is known to spare surrounding tissues and organs from unnecessary radiation. Proton radiation delivers radiation to the area requiring radiation. This may reduce side effects that patients would normally experience with standard radiation therapy or other means of delivering proton radiation therapy. In this research study, the investigators are evaluating the effectiveness of using proton radiation delivered to reduce side effects associated with radiation treatment. The investigators will also be assessing the late side effects experienced by participants in each treatment group.

Key Dates

Start date
Jun 30, 2014
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Mar 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Proton Beam Radiation Therapy (PBRT)
    Proton radiation will be delivered daily for 3-4 weeks, depending on the dose prescribed by study doctor. Treatment is delivered (Monday - Friday) for 5 days (no weekends or holidays). Each treatment the participant will lie on a table for 30-45 minutes.

Primary Outcome Measure

Describe late complications of radiation therapy delivered with proton radiotherapy in place of photon radiation for patients with neuroblastoma [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Shannon M. MacDonald, MD
[email protected]
617-643-7250
Shannon M. MacDonald, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Massachusetts General Hospital· Boston, MA

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