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Proton Beam Therapy

Reduced-dose Radiotherapy for Neuroblastoma

N/A

Recruiting

Led By Suzanne Wolden, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

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 must have a diagnosis of neuroblastoma (International Classification of Disease for Oncology [ICD-O] morphology 9500/3) confirmed by MSKCC pathologic review

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing a lower dose of radiation to see if it decreases side effects experienced years after treatment.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed here, reduced-dose radiation may still cause skin irritation, fatigue, changes in appetite, and potential risks to growth and development due to the patient's young age.

Eligibility Criteria

Inclusion Criteria

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

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

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My diagnosis of neuroblastoma has been confirmed by a specialist.

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My cancer is stage 2 with MYCN gene changes.

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I am between 1 month and 18 years old.

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I am willing to stop breast-feeding if I join the trial.

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I've had chemotherapy and surgery for advanced neuroblastoma.

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My neuroblastoma is classified as high-risk.

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My cancer is stage 4s with MYCN gene changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

assess local control rates treatment response

Secondary outcome measures

Assessment of toxicity

event-free survival

Side effects data

From 2016 Phase 2 trial • 129 Patients • NCT00091390

78%

Pollakiuria

57%

Erectile dysfunction NOS

40%

Urinary retention

26%

Diarrhea NOS

21%

Urinary incontinence

20%

Rectal hemorrhage

20%

Libido decreased

20%

Fatigue

19%

Urogenital hemorrhage

18%

Renal/genitourinary - Other

17%

Urethral pain

12%

Hot flushes NOS

10%

Proctitis NOS

10%

Cystitis NOS

Hemoglobin

Bladder pain

Urethral obstruction

Penile pain

Constipation

Urethral stricture

Ejaculatory disorder NOS

Pain - Other

Urinary bladder hemorrhage

Fanconi syndrome acquired

Hyponatremia

Arthritis NOS

Musculoskeletal/soft tissue - Other

Depression

Flushing

Hypertension NOS

Fecal incontinence

Gastrointestinal - Other

Infection - Other

Blood creatinine increased

Ureteric obstruction

100%

80%

60%

40%

20%

Study treatment Arm

EBRT and HDR Brachytherapy Boost

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

External beam radiotherapy

2004

Completed Phase 2

~130

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,814 Total Patients Enrolled

49 Trials studying Neuroblastoma

5,716 Patients Enrolled for Neuroblastoma

Suzanne Wolden, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

35 Total Patients Enrolled

Media Library

Proton Beam RT (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02245997 — N/A

Neuroblastoma Research Study Groups: patients with high-risk neuroblastoma

Neuroblastoma Clinical Trial 2023: Proton Beam RT Highlights & Side Effects. Trial Name: NCT02245997 — N/A

Proton Beam RT (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02245997 — N/A

Frequently Asked Questions

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

Am I eligible to participate in this experimental research?

"This clinical trial is actively recruiting 75 paediatric patients (ranging from 1 month to 18 years of age) with neuroblastoma. To qualify for this study, participants are expected to have already received chemotherapy and surgery for their high-risk condition. Additionally, female participants must be tested negative for pregnancy 14 days prior to the start of radiation treatment. Furthermore, enrolled children aged between 1 -18 months must possess MYCN amplification or an unfavorable pathology/DNA index =1; while those over 18 months need only present unfavorable pathology regardless ofMYCN status."

Answered by AI

Is eligibility for the trial limited to individuals below 80 years of age?

"As per the requirements of this clinical trial, participants need to be between 12 months and 18 years old."

Answered by AI

How many participants are being observed in this research trial?

"Affirmative, clinicaltrials.gov states that this scientific experiment is presently enrolling participants and was first advertised on September 1st 2014. The study requires 75 people to be recruited from a single location, with the most recent update being made on October 31st 2022."

Answered by AI

Is recruitment still underway for this clinical trial?

"The data hosted on clinicaltrials.gov reports that this medical trial is presently open to participants, with the experiment first posted on 9/1/2014 and most recently updated 10/31/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma

2014. "Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02245997.

All > Neuroblastoma