NeuroblastomaEarly Phase 1NCT02245997
Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
A Early Phase 1 study testing External beam radiotherapy and proton beam RT in people with Neuroblastoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to give 12T a smaller dose of radiation in order to decrease these late side effects. Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- External beam radiotherapy and proton beam RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 1 May 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must have a diagnosis of neuroblastoma (International Classification of Disease for Oncology [ICD-O] morphology 9500/3) confirmed by MSKCC pathologic review
- Patients must have high-risk neuroblastoma as defined by the COG Risk Stratification Schema
- o Patients with International agreement on staging (INSS) stage 4 are eligible with the following:
- MYCN amplification, regardless of age or additional biologic features
- Age >18 months, regardless of biologic features OR
- Age 1-18 months, with any of the 3 following unfavorable biologic OR features: MYCN amplification, unfavorable pathology, and/or DNA index = 1
Show all 17Show fewer
- o 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
- o Patients with INSS stage 2a or 2b are eligible with the following:
- MYCN amplification, regardless of age or additional biologic features
- o Patients with INSS stage 4s are eligible with the following:
- MYCN amplification, regardless of additional biologic features Patients must have undergone chemotherapy and surgery for high-risk neuroblastoma prior to enrollment on trial.
- Age at time of enrollment of ≥1 month and ≤18 years
- Female patients of childbearing potential must have a negative pregnancy test within 14 days of radiation start.
- Female patients who are lactating must agree to stop breast-feeding.
- Sexually active patients of childbearing potential must agree to use effective contraception.
Who cannot join
- Patients with gross residual tumor after surgical resection
- Patients who have received prior radiotherapy at or adjacent to the primary tumor bed
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to give 12T a smaller dose of radiation in order to decrease these late side effects.
- Conditions
- Neuroblastoma
- Being tested
- External beam radiotherapy, proton beam RT
- Keywords
- Reduced-dose Radiotherapy, 14-186
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External beam radiotherapyRadiation
Also called IMRT
proton beam RTRadiation
| Study group | Role | What they receive |
|---|---|---|
| patients with high-risk neuroblastoma | Experimental | 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). Receives: Radiation: External beam radiotherapy; Radiation: proton beam RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess local control rates treatment response
will be assessed via imaging (CT+/- MRI and MIBG) and clinical evidence at the primary site post completion of treatment. The baseline scan will be the pre-irradiation CT scan. Local failure is defined as a relapse in the primary tumor bed or adjacent lymph nodes.
Measured: 3 yeas
Secondary outcomes (2)
event-free survival
will be performed for each patient using clinical data and imaging. Events are defined as failure (loco-regional and/or distant), treatment-related malignancy, or death.
Measured: 3 years
Assessment of toxicity
will occur at the pre-specified follow-up time-points using the CTCAE version 4.0 grading system.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Wolden, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245997
- Sponsor's protocol ID
- 14-186
- Status last verified
- Jul 2025
- First submitted
- 17 Sep 2014
- Last updated
- 29 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
- ClinicalTrials.gov ID
- NCT02245997
- Acronym / sponsor ID
- 14-186
- Conditions
- Neuroblastoma
- Keywords
- Reduced-dose Radiotherapy, 14-186
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to give 12T a smaller dose of radiation in order to decrease these late side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with high-risk neuroblastoma | Experimental | Radiation: External beam radiotherapy, Radiation: proton beam RTPatients 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 may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- Patients must have a diagnosis of neuroblastoma (International Classification of Disease for Oncology [ICD-O] morphology 9500/3) confirmed by MSKCC pathologic review
- Patients must have high-risk neuroblastoma as defined by the COG Risk Stratification Schema
- o Patients with International agreement on staging (INSS) stage 4 are eligible with the following:
- MYCN amplification, regardless of age or additional biologic features
- Age >18 months, regardless of biologic features OR
Key exclusion criteria (3 listed)
- Patients with gross residual tumor after surgical resection
- Patients who have received prior radiotherapy at or adjacent to the primary tumor bed
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External beam radiotherapyAlso: IMRT | Radiation | patients with high-risk neuroblastoma |
| proton beam RT | Radiation | patients with high-risk neuroblastoma |
Primary outcome
assess local control rates treatment response
Time frame: 3 yeas
will be assessed via imaging (CT+/- MRI and MIBG) and clinical evidence at the primary site post completion of treatment. The baseline scan will be the pre-irradiation CT scan. Local failure is defined as a relapse in the primary tumor bed or adjacent lymph nodes.
2 secondary outcomes
event-free survival
Time frame: 3 years
Assessment of toxicity
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Wolden, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing External beam radiotherapy and proton beam RT in people with Neuroblastoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess local control rates treatment response (time frame: 3 yeas). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.