Reduced-dose Radiotherapy for Neuroblastoma

Recruiting in Palo Alto (17 mi)

Overseen bySuzanne Wolden, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to give 12T a smaller dose of radiation in order to decrease these late side effects.

Eligibility Criteria

This trial is for children and young adults (1 month to 18 years old) with high-risk neuroblastoma who've had chemotherapy and surgery. They must not be pregnant, breastfeeding, or have any leftover large tumors after surgery. If they can have children, they need to use birth control and have a negative pregnancy test before starting.

Inclusion Criteria

I have stage 3 neuroblastoma with MYCN amplification or I am over 18 months old with unfavorable pathology.

Patients with International agreement on staging (INSS) stage 4 are eligible with the following: MYCN amplification, regardless of age or additional biologic features; Age >18 months, regardless of biologic features OR Age 1-18 months, with any of the 3 following unfavorable biologic OR features: MYCN amplification, unfavorable pathology, and/or DNA index = 1; Patients with INSS stage 3 are eligible with the following: MYCN amplification, regardless of age or additional biologic features OR Age > 18 months with unfavorable pathology, regardless of MYCN status; Patients with INSS stage 2a or 2b are eligible with the following: MYCN amplification, regardless of age or additional biologic features; Patients with INSS stage 4s are eligible with the following: MYCN amplification, regardless of additional biologic features; Patients must have undergone chemotherapy and surgery for high-risk neuroblastoma prior to enrollment on trial; Age at time of enrollment of ≥1 month and ≤18 years; Female patients of childbearing potential must have a negative pregnancy test within 14 days of radiation start; Female patients who are lactating must agree to stop breast-feeding; Sexually active patients of childbearing potential must agree to use effective contraception.

My diagnosis of neuroblastoma has been confirmed by a specialist.

+9 more

Exclusion Criteria

I still have visible tumor after surgery.

Patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.

I have had radiation therapy on or near where my tumor was located.

Participant Groups

The study tests whether using a lower dose of radiation therapy (proton beam RT or external beam radiotherapy) can effectively treat neuroblastoma while reducing long-term side effects from the treatment.

1Treatment groups

Experimental Treatment

Group I: patients with high-risk neuroblastomaExperimental Treatment2 Interventions

Patients undergo external beam radiation therapy using IMRT or proton beam RT twice daily for 5-6 weekdays (10-12 treatments). Patients will be evaluated by physical exams, CT scan or MRI of the primary site, and MIBG at, 6, 12, 18 and 24 months (+/- 6 weeks).