Back to results

Phase II Study of Proton Radiation Therapy for Neuroblastoma

Primary Purpose

Neuroblastoma, Ganglioneuroblastoma

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Proton Beam Radiation Therapy

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring Neuroblastoma, Childhood neuroblastoma, Ganglioneuroblastoma, Pediatric neuroblastoma

Eligibility Criteria

6 Months - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites. If tumor tissue was obtained, pathological review of surgical specimen at the Massachusetts General Hospital or other DF/HCC institution is required, but preliminary report only required prior to enrollment. If no tumor tissue was obtained, urinary catecholamine metabolites are required.
Participants do not need to have measurable disease at the time of radiation. Age ≥ 3 and ≤ 25 years at the time of diagnosis because this study evaluates this disease entity in the pediatric population which may differ from the adult population.
Life expectancy of greater than 12 months.
ECOG performance status ≤2 (Karnofsky ≥60%, Lansky ≥60%, see Appendix A).
Diagnostic Imaging MRI and/or CT of the area to be treated within 8 weeks of any treatment. Baseline bone marrow biopsy and bone scan (with 99mTc-diphosphonate or MIBG scan (131I-MIBG or 123I-MIBG) from time of original diagnosis is required.
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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability of the patient or the patient's legal guardian to understand and the willingness to sign a written informed consent document.
Participants or their legal guardian must sign consent prior to the initiation of radiation therapy.

Exclusion Criteria:

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.
Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
Pregnant females are excluded. Women of childbearing age/menstruating must have a negative pregnancy test prior to initiation of radiation therapy.

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton Beam Radiation Therapy (PBRT)

Arm Description

Outcomes

Primary Outcome Measures

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

To describe late complications of radiation therapy delivered with proton radiotherapy in place of photon radiation for patients with neuroblastoma. Specifically, cardiac, pulmonary, gastrointestinal, endocrine, growth and second malignancies will be described.

To evaluate acute and subacute toxicities of 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. Specifically, nausea, vomiting, diarrhea, radiation pneumonitis and skin toxicity will be described.

Secondary Outcome Measures

Progression free survival

Overall survival rates

Full Information

NCT ID

NCT02112617

First Posted

April 10, 2014

Last Updated

January 3, 2021

Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02112617

Brief Title

Phase II Study of Proton Radiation Therapy for Neuroblastoma

Official Title

Phase II Study of Proton Radiation Therapy for Neuroblastoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Recruiting

Study Start Date

June 2014 (undefined)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This research study is evaluating a therapy called proton beam radiation therapy (PBRT) as a possible treatment for neuroblastoma. Neuroblastoma most commonly occurs in and around the adrenal glands, which are located at the top of the kidneys. However, it can also occur in other areas where groups of nerve cells exist, such as other areas of the abdomen, neck and near the spine. Conventional radiation therapy with photons is used as standard treatment for many patients with neuroblastic tumors. In this research study, the investigators are looking at another type of radiation called proton radiation which is known to spare surrounding tissues and organs from unnecessary radiation. Proton radiation delivers radiation to the area requiring radiation. This may reduce side effects that patients would normally experience with standard radiation therapy or other means of delivering proton radiation therapy. In this research study, the investigators are evaluating the effectiveness of using proton radiation delivered to reduce side effects associated with radiation treatment. The investigators will also be assessing the late side effects experienced by participants in each treatment group.

Detailed Description

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. The radiation therapy will be outpatient at Massachusetts General Hospital. During radiation therapy, the participant will have the following weekly assessments and procedures: Physical Exam Assess for any side effects Routine blood tests (weekly or at least every other week) Post-treatment Follow Up Visit (s): The participant will be asked to return to the clinic 3-6 months after their last dose of radiation therapy and then annually for up to 5 years for the following procedures: Medical History Physical Exam Diagnostic Imaging Assess for side effects Lung Function Tests (if required) MUGA or ECHO (if required)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroblastoma, Ganglioneuroblastoma

Keywords

Neuroblastoma, Childhood neuroblastoma, Ganglioneuroblastoma, Pediatric neuroblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Proton Beam Radiation Therapy (PBRT)

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Proton Beam Radiation Therapy

Intervention Description

Primary Outcome Measure Information:

Title

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

Description

Time Frame

5 years

Title

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

Description

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Progression free survival

Time Frame

10 years

Title

Overall survival rates

Time Frame

10 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites. If tumor tissue was obtained, pathological review of surgical specimen at the Massachusetts General Hospital or other DF/HCC institution is required, but preliminary report only required prior to enrollment. If no tumor tissue was obtained, urinary catecholamine metabolites are required. Participants do not need to have measurable disease at the time of radiation. Age ≥ 3 and ≤ 25 years at the time of diagnosis because this study evaluates this disease entity in the pediatric population which may differ from the adult population. Life expectancy of greater than 12 months. ECOG performance status ≤2 (Karnofsky ≥60%, Lansky ≥60%, see Appendix A). Diagnostic Imaging MRI and/or CT of the area to be treated within 8 weeks of any treatment. Baseline bone marrow biopsy and bone scan (with 99mTc-diphosphonate or MIBG scan (131I-MIBG or 123I-MIBG) from time of original diagnosis is required. 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Ability of the patient or the patient's legal guardian to understand and the willingness to sign a written informed consent document. Participants or their legal guardian must sign consent prior to the initiation of radiation therapy. Exclusion Criteria: 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. Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin. Pregnant females are excluded. Women of childbearing age/menstruating must have a negative pregnancy test prior to initiation of radiation therapy.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shannon M MacDonald, MD

Phone

617-643-7250

smacdonald@partners.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shannon M. MacDonald, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shannon M. MacDonald, MD

Phone

617-643-7250

smacdonald@partners.org

First Name & Middle Initial & Last Name & Degree

Shannon M. MacDonald, MD

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of Proton Radiation Therapy for Neuroblastoma

We'll reach out to this number within 24 hrs