Germ Cell TumorNCT01049230
Proton Beam Radiation Therapy for Central Nervous System (CNS) Germ Cell Tumors
A study testing Proton Beam radiation in people with Germ Cell Tumor and Central Nervous System Germ Cell Tumor, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 25 years
- Conditions the study is for
- Germ Cell Tumor, Central Nervous System Germ Cell Tumor
- What is being tested?
- Proton Beam radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase II Study of Proton Radiation Therapy for CNS Germ Cell Tumors: Evaluation of Acute and Late Side Effects
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.
Read the 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.
- Being tested
- Proton Beam radiation
- Keywords
- proton beam radiation, CNS germ cell tumor
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Beam radiationRadiation
Once a day, 5 days a week (Monday-Friday), for 4-8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Proton beam radiation | Experimental | Radiation therapy with proton beam Receives: Radiation: Proton Beam radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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.
Measured: 2 years
Secondary outcomes (1)
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.
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 posted14 Jan 2010 (estimated)
- Study startJun 2010
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Kevin X. Liu, MD, DPHIL, Massachusetts General Hospital
- Investigators
- Shannon MacDonald, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049230
- Sponsor's protocol ID
- 09-263
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2010
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Proton Radiation Therapy for CNS Germ Cell Tumors: Evaluation of Acute and Late Side Effects
- ClinicalTrials.gov ID
- NCT01049230
- Acronym / sponsor ID
- 09-263
- Keywords
- proton beam radiation, CNS germ cell tumor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, National Institutes of Health (NIH)
- Study start
- Jun 2010
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Jan 2010 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton beam radiation | Experimental | Radiation: Proton Beam radiationRadiation therapy with proton beam |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Proton Beam radiationOnce a day, 5 days a week (Monday-Friday), for 4-8 weeks | Radiation | Proton beam radiation |
Primary outcome
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
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.
Time frame: 2 years
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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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.
Shannon MacDonald, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton Beam radiation in people with Germ Cell Tumor and Central Nervous System Germ Cell Tumor, run by Massachusetts General Hospital at 2 sites 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 8 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
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). The study lists 2 primary outcomes in all. 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 Oct 2026.