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

Phase 2
3 Years
Open (Enrolling)
Germ Cell Tumor, Central Nervous System Germ Cell Tumor

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Trial Information

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

- 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

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 older a 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Shannon MacDonald, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

June 2010

Completion Date:

October 2015

Related Keywords:

  • Germ Cell Tumor
  • Central Nervous System Germ Cell Tumor
  • proton beam radiation
  • CNS germ cell tumor
  • Neoplasms, Germ Cell and Embryonal



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617