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

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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

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.
    


Study Type

Interventional


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.

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.

Condition

Germ Cell Tumor

Intervention

Proton Beam radiation

Study Arms / Comparison Groups

 Proton beam radiation
Description:  Radiation therapy with proton beam

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

45

Start Date

June 2010

Completion Date

August 2022

Primary Completion Date

August 2022

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
      

Gender

All

Ages

3 Years - 25 Years

Accepts Healthy Volunteers

No

Contacts

Shannon MacDonald, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01049230

Organization ID

09-263


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital

Collaborators

 Dana-Farber Cancer Institute

Study Sponsor

Shannon MacDonald, MD, Principal Investigator, Massachusetts General Hospital


Verification Date

January 2021