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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Secondary outcome measures

Overall survival rates

Progression free survival

Side effects data

From 2020 Phase 2 trial • 35 Patients • NCT02073968

71%

Cough

69%

Dysphagia

54%

Dermatitis

40%

Anorexia

23%

Constipation

11%

Dehydration

Fatigue

Pneumonitis

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel)

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,703 Previous Clinical Trials

40,931,720 Total Patients Enrolled

205 Trials studying Neuroblastoma

53,654 Patients Enrolled for Neuroblastoma

Massachusetts General HospitalLead Sponsor

2,941 Previous Clinical Trials

13,200,638 Total Patients Enrolled

Shannon M. MacDonald, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Proton Beam Radiation Therapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02112617 — N/A

Neuroblastoma Research Study Groups: Proton Beam Radiation Therapy (PBRT)

Neuroblastoma Clinical Trial 2023: Proton Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT02112617 — N/A

Proton Beam Radiation Therapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02112617 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria need to be met for individuals to qualify as participants in this research?

"This trial is recruiting 30 children and adolescents with neuroblastoma, aged between 6 months and 25 years. Those interested should meet the following prerequisites: no demonstrable disease at radiation commencement; age within 3-25 years of diagnosis as this investigation focuses on pediatric patients; predicted life expectancy surpassing 12 months; ECOG performance status not exceeding 2 (Karnofsky ≥60%, Lansky ≥60%); agreement signed by participants or their legal guardians before radiotherapy commences."

Answered by AI

Would persons over the age of twenty be accepted into this research trial?

"This clinical examination is open to individuals between 6 months and 25 years old. There are 160 studies for minors, and 43 studies available for seniors over 65."

Answered by AI

Are there opportunities for people to participate in this research project at present?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical study is actively recruiting participants. Initially posted on June 1st 2014 and most recently updated on January 3rd 2021, the trial requires 30 patients to be enrolled at one site of operation."

Answered by AI

What is the total capacity for participants in this clinical research?

"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical study, inaugurated June 1st 2014, is actively searching for participants. The team behind the trial must recruit around 30 patients from a single site in order to reach their quota."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Study of Proton Radiation Therapy for Neuroblastoma

Shannon MacDonald, MD 2014. "Phase II Study of Proton Radiation Therapy for Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02112617.

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