Proton Beam Radiation Therapy for Central Nervous System (CNS) Germ Cell Tumors
This study is currently recruiting participants.
(see Contacts and Locations)
Verified March 2016 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Collaborators:
Dana-Farber Cancer Institute
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Shannon MacDonald, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01049230
First received: January 13, 2010
Last updated: March 4, 2016
Last verified: March 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Germ Cell Tumor Central Nervous System Germ Cell Tumor |
Radiation: Proton Beam radiation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Proton Radiation Therapy for CNS Germ Cell Tumors: Evaluation of Acute and Late Side Effects |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Proton beam radiation
Radiation therapy with proton beam
|
Radiation: Proton Beam radiation
Once a day, 5 days a week (Monday-Friday), for 4-8 weeks
|
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.
Eligibility| Ages Eligible for Study: | 3 Years to 25 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049230
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049230
Contacts
| Contact: Shannon MacDonald, MD | 617-643-7250 | smacdonald@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Shannon MacDonald, M.D. 617-643-7250 | |
| Principal Investigator: Shannon MacDonald, MD | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Karen Marcus, MD | |
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
National Institutes of Health (NIH)
Investigators
| Principal Investigator: | Shannon MacDonald, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Shannon MacDonald, MD, Attending Radiation Oncologist, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01049230 History of Changes |
| Other Study ID Numbers: | 09-263 |
| Study First Received: | January 13, 2010 |
| Last Updated: | March 4, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
proton beam radiation CNS germ cell tumor |
Additional relevant MeSH terms:
|
Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on September 26, 2016