Reduced-dose Radiotherapy for Neuroblastoma

Overseen By Brian Kushner, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Residual tumor, Prior radiotherapy, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

78 Participants Needed

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.

Research Team

Suzanne Wolden, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

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.

My diagnosis of neuroblastoma has been confirmed by a specialist.

I am a woman who can have children and have a recent negative pregnancy test.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Patients undergo external beam radiation therapy using IMRT or proton beam RT twice daily for 5-6 weekdays (10-12 treatments)

1-2 weeks

10-12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at 6, 12, 18, and 24 months

24 months

4 visits (in-person)

Long-term follow-up

Event-free survival and assessment of toxicity will be monitored over 3 years

3 years

Treatment Details

Interventions

• External Beam Radiotherapy
• Proton Beam RT

Trial Overview 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.

Participant Groups

Group I: patients with high-risk neuroblastoma Experimental Treatment 2 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).

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+