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Proton Beam Radiation Therapy for Central Nervous System (CNS) Germ Cell Tumors

Primary Purpose

Germ Cell Tumor, Central Nervous System Germ Cell Tumor

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Proton Beam radiation

About this trial

This is an interventional treatment trial for Germ Cell Tumor focused on measuring proton beam radiation, CNS germ cell tumor

Eligibility Criteria

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

Inclusion Criteria:

Histologically confirmed germ cell tumor or elevated AFP or B-HCG in the setting of radiographic disease consistent with a germ cell tumor. Disease must be confined to the central nervous system.
Participants do not need to have measurable disease. Most patients will not have measurable disease at the time of treatment.
3 years of age or older and 25 years of age or younger 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 of 0, 1 or 2
Baseline MRI of the brain and spinal axis with gadolinium and prior to any chemotherapy is required. If surgical resection is performed a post-operative MRI is required. If the patient receives chemotherapy prior to radiation, a post-chemotherapy MRI of the brain is required. If spinal involvement was seen on initial MRI and prior to chemotherapy, a MRI of the spine is required after chemotherapy and prior to radiation.
Serum and lumbar CSF must be obtained to evaluate for alpha fetoprotein (AFP) and beta human chorionic gonadotropin (HCG). This is needed to stratify patients into pure GCT and NGGCT.
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria:

Patients will be ineligible if any prior therapeutic radiation therapy > 200 cGy has been delivered to the central nervous system.
Patients will be ineligible if chemotherapy was completed greater than 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: Disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals diagnosed and treated within the past 5 years for cervical cancer in situ and basal cell or squamous cell carcinoma of the skin.
Pregnant females

Sites / Locations

Massachusetts General Hospital
Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton beam radiation

Arm Description

Radiation therapy with proton beam

Outcomes

Primary Outcome Measures

To describe late complications of craniospinal, whole ventricle, and involved field radiation therapy delivered with proton radiotherapy in place of photon radiation for this patient population.

To evaluate acute and subacute toxicities of craniospinal, whole ventricle, and involved field radiation therapy delivered with proton radiotherapy in place of photon radiation in this patient population.

Secondary Outcome Measures

To determine 3 year progression free survival rate of patients with pure germ cell tumors and non-germinomatous germ cell tumors treated with proton radiation.

Full Information

NCT ID

NCT01049230

First Posted

January 13, 2010

Last Updated

January 3, 2021

Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute, National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT01049230

Brief Title

Proton Beam Radiation Therapy for Central Nervous System (CNS) Germ Cell Tumors

Official Title

Phase II Study of Proton Radiation Therapy for CNS Germ Cell Tumors: Evaluation of Acute and Late Side Effects

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 2010 (undefined)

Primary Completion Date

August 2022 (Anticipated)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute, National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this research study is to determine if radiation using proton beam therapy will kill the germ cell tumor in the participant's central nervous system. This type of radiation has been used previously on many patients with different types of cancers. There are two types of external radiation treatments, proton beam and photon beam. In this study we will be examining the effects of proton beam radiation therapy. Studies have suggested that this kind of radiation can spare normal tissue more than photon radiation therapy. The physical characteristics of proton beam radiation let the doctor safely increase the amount of radiation delivered to the tumor. We believe that proton beam therapy will potentially reduce side effects that participants would normally experience with photon radiation therapy.

Detailed Description

Before participants begin radiation therapy they will have scans done to prepare them for radiation treatment. Doctors will use the information gathered from these scans to plan the best way to deliver radiation to the tumor. Participants will receive treatment as an outpatient at the Francis H. Burr Proton Center located at the Massachusetts General Hospital. Not everyone who participates in this study will receive the same amount of proton radiation therapy. The length of time and amount of radiation that the participant will receive will depend on the type of germ cell tumor they have and the stage of the their disease. Radiation treatment will be given once a day, 5 days a week (Monday-Friday), for 4-8 weeks depending on the condition of the participant's disease. During each week of proton radiation therapy, participants will have a physical exam and be asked questions about their general health and any problems they might be experiencing.

6. Conditions and Keywords

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

Germ Cell Tumor, Central Nervous System Germ Cell Tumor

Keywords

proton beam radiation, CNS germ cell tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Proton beam radiation

Arm Type

Experimental

Arm Description

Radiation therapy with proton beam

Intervention Type

Radiation

Intervention Name(s)

Proton Beam radiation

Intervention Description

Once a day, 5 days a week (Monday-Friday), for 4-8 weeks

Primary Outcome Measure Information:

Title

To describe late complications of craniospinal, whole ventricle, and involved field radiation therapy delivered with proton radiotherapy in place of photon radiation for this patient population.

Time Frame

2 years

Title

Time Frame

2 years

Secondary Outcome Measure Information:

Title

To determine 3 year progression free survival rate of patients with pure germ cell tumors and non-germinomatous germ cell tumors treated with proton radiation.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed germ cell tumor or elevated AFP or B-HCG in the setting of radiographic disease consistent with a germ cell tumor. Disease must be confined to the central nervous system. Participants do not need to have measurable disease. Most patients will not have measurable disease at the time of treatment. 3 years of age or older and 25 years of age or younger 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 of 0, 1 or 2 Baseline MRI of the brain and spinal axis with gadolinium and prior to any chemotherapy is required. If surgical resection is performed a post-operative MRI is required. If the patient receives chemotherapy prior to radiation, a post-chemotherapy MRI of the brain is required. If spinal involvement was seen on initial MRI and prior to chemotherapy, a MRI of the spine is required after chemotherapy and prior to radiation. Serum and lumbar CSF must be obtained to evaluate for alpha fetoprotein (AFP) and beta human chorionic gonadotropin (HCG). This is needed to stratify patients into pure GCT and NGGCT. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: Patients will be ineligible if any prior therapeutic radiation therapy > 200 cGy has been delivered to the central nervous system. Patients will be ineligible if chemotherapy was completed greater than 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: Disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals diagnosed and treated within the past 5 years for cervical cancer in situ and basal cell or squamous cell carcinoma of the skin. Pregnant females

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shannon 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

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Proton Beam Radiation Therapy for Central Nervous System (CNS) Germ Cell Tumors

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