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Proton Beam Therapy

Reduced-dose Radiotherapy for Neuroblastoma

N/A

Waitlist Available

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

Must not have

Patients with gross residual tumor after surgical resection

Patients who have received prior radiotherapy at or adjacent to the primary tumor bed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I still have visible tumor after surgery.

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

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

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

Primary study objectives

assess local control rates treatment response

Secondary study objectives

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%

Libido decreased

20%

Fatigue

20%

Rectal hemorrhage

19%

Urogenital hemorrhage

18%

Renal/genitourinary - Other

17%

Urethral pain

12%

Hot flushes NOS

10%

Cystitis NOS

10%

Proctitis NOS

Bladder pain

Hemoglobin

Urethral obstruction

Penile pain

Urethral stricture

Ejaculatory disorder NOS

Constipation

Pain - Other

Urinary bladder hemorrhage

Fanconi syndrome acquired

Fecal incontinence

Arthritis NOS

Depression

Infection - Other

Blood creatinine increased

Hyponatremia

Ureteric obstruction

Gastrointestinal - Other

Hypertension NOS

Musculoskeletal/soft tissue - Other

Flushing

100%

80%

60%

40%

20%

Study treatment Arm

EBRT and HDR Brachytherapy Boost

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: 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 / 10Eligibility criteria met