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Proton Beam Therapy

Proton Radiation Therapy for Neuroblastoma

N/A

Recruiting

Led By Shannon M. MacDonald, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Because radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

ECOG performance status ≤2 (Karnofsky ≥60%, Lansky ≥60%, see Appendix A)

Must not have

Patients will be ineligible if any prior therapeutic radiation therapy > 500 cGy has been delivered

Patients will be ineligible if chemotherapy was completed ≥ 1 year from the planned start date of radiation therapy or if the patient is referred for radiation therapy after a relapse following a regimen with chemotherapy alone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at proton beam radiation therapy (PBRT) as a possible treatment for neuroblastoma. Neuroblastoma is a cancer that most commonly occurs in and around the adrenal glands, but can also occur in other areas where groups of nerve cells exist. Standard radiation therapy with photons is used as standard treatment for many patients with neuroblastic tumors, but proton radiation is known to spare surrounding tissues and organs from unnecessary radiation. The trial will assess the effectiveness of PBRT in reducing side effects associated with radiation treatment and the late side effects experienced by participants.

Who is the study for?

This trial is for children and young adults aged 3 to 25 with neuroblastoma or ganglioneuroblastoma. Participants must have confirmed diagnosis, agree to use contraception if of child-bearing age, and have a life expectancy over 12 months. Excluded are those who've had certain prior treatments or cancers, except specific low-risk cases.

What is being tested?

The study tests proton beam radiation therapy (PBRT) as a treatment for neuroblastoma, aiming to reduce side effects compared to standard photon radiation by sparing surrounding tissues from unnecessary exposure.

What are the potential side effects?

While PBRT aims to minimize side effects by targeting the tumor more precisely than traditional radiation therapy, potential side effects may include skin reactions at the site of treatment, fatigue, hair loss in the treated area, and possible damage to nearby organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use effective birth control or abstain from sex during the study.

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I can take care of myself but might not be able to do active work.

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I have a confirmed diagnosis of neuroblastoma or ganglioneuroblastoma.

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I was diagnosed with my condition between the ages of 3 and 25.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received radiation therapy above 500 cGy.

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I haven't completed chemotherapy more than a year ago or had a relapse after chemotherapy alone before radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Describe late complications of radiation therapy delivered with proton radiotherapy in place of photon radiation for patients with neuroblastoma

To evaluate acute and subacute toxicities of proton radiotherapy in place of photon radiation for patients with neuroblastoma.

Side effects data

From 2020 Phase 2 trial • 35 Patients • NCT02073968

71%

Cough

69%

Dysphagia

54%

Dermatitis

40%

Anorexia

23%

Constipation

11%

Dehydration

Pneumonitis

Fatigue

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Proton Beam Radiation Therapy (PBRT)Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Proton Beam Radiation Therapy

2013

Completed Phase 2

~110

0 / 6Eligibility criteria met