Clinical Trial: Phase II Study of Proton Radiation Therapy for Neuroblastoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Study of Proton Radiation Therapy for Neuroblastoma

Brief Summary:

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.


Detailed Summary:

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.

The radiation therapy will be outpatient at Massachusetts General Hospital.

During radiation therapy, the participant will have the following weekly assessments and procedures:

  • Physical Exam
  • Assess for any side effects
  • Routine blood tests (weekly or at least every other week)

Post-treatment Follow Up Visit (s):

The participant will be asked to return to the clinic 3-6 months after their last dose of radiation therapy and then annually for up to 5 years for the following procedures:

  • Medical History
  • Physical Exam
  • Diagnostic Imaging
  • Assess for side effects
  • Lung Function Tests (if required)
  • MUGA or ECHO (if required)

Sponsor: Massachusetts General Hospital

Current Primary Outcome:

  • Describe late complications of radiation therapy delivered with proton radiotherapy in place of photon radiation for patients with neuroblastoma [ Time Frame: 5 years ]
    To describe late complications of radiation therapy delivered with proton radiotherapy in place of photon radiation for patients with neuroblastoma. Specifically, cardiac, pulmonary, gastrointestinal, endocrine, growth and second malignancies will be described.
  • To evaluate acute and subacute toxicities of proton radiotherapy in place of photon radiation for patients with neuroblastoma. [ Time Frame: 5 years ]
    To evaluate acute and subacute toxicities of proton radiotherapy in place of photon radiation for patients with neuroblastoma. Specifically, nausea, vomiting, diarrhea, radiation pneumonitis and skin toxicity will be described.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression free survival [ Time Frame: 10 years ]
  • Overall survival rates [ Time Frame: 10 Years ]


Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: April 10, 2014
Date Started: June 2014
Date Completion: March 2028
Last Updated: April 14, 2017
Last Verified: April 2017