Clinical Trial - NCT03286335

Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy

Recruiting

Sponsor: Massachusetts General Hospital

Collaborators:

Information provided by (Responsible party): Principal Investigator Massachusetts General Hospital Helen A. Shih, MD Shih, Helen A, MD

ClinicalTrials.gov Identifier: NCT03286335

Protocol Info

Short Description: PROTON RADIATION THERAPY IN BRAIN TUMORS
Long Description: Local Control, Quality of Life and Toxicities in Adults with Benign or Indolent Brain Tumors undergoing Proton Radiation Therapy
MGH Status: Open
Sponsor: DF/HCC
Disease Program: Proton

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

This research study is studying Proton Radiation as a possible treatment for brain tumor. The radiation involved in this study is: -Proton Radiation
Condition Title Intervention Phase
Brain Tumor Proton Radiation N/A
Study Type Interventional
Official Title Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy

Primary Outcome Measures

Duration of Local Control [Time Frame: 2 years] [Designated as safety issue: ]


Secondary Outcome Measures

Quality of Life Assessment EORTC-QLQ-C30 [Time Frame: 2 years] [Designated as safety issue: ]

Quality of Life Assessment EORTC-QLQ-BN20 [Time Frame: 2 Years] [Designated as safety issue: ]

Quality of Life Assessment HADS [Time Frame: 2 Years] [Designated as safety issue: ]

Vision Loss [Time Frame: 2 years] [Designated as safety issue: ]

Ototoxicity [Time Frame: 2 years] [Designated as safety issue: ]

Neuroendocrine dysfunction [Time Frame: 2 years] [Designated as safety issue: ]

Neurocognitive effects [Time Frame: 2 years] [Designated as safety issue: ]

Alopecia [Time Frame: 2 years] [Designated as safety issue: ]

CD4 count [Time Frame: 2 years] [Designated as safety issue: ]

Estimated Enrollment: 100
Study Start Date: September 2018
Estimated Study Completion Date: September 2027
Estimated Primary Completion Date: September 2025
Arms Assigned Interventions

Experimental:Proton Radiation

Radiation therapy will be delivered typically five (5) days per week on weekdays Proton Radiation dose be determine by histology
Radiation:Proton Radiation
Radiation treatment

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Biopsy-proven benign or malignant brain tumor requiring tumor bed or tumor irradiation. This may include, but is not limited to, low-grade or favorable high-grade glioma, pituitary adenoma, vestibular schwannoma (acoustic neuroma), and meningioma as the most common diagnoses. Other tumor types that require irradiation and are deemed appropriate for proton radiation therapy are also eligible. Patients with a presumed diagnosis based on imaging and clinical characteristics will be permitted on this trial without pathological diagnostic confirmation if it is within standard of care to offer radiation therapy without a biopsy.
  • Participants must otherwise be indicated for proton radiation therapy
  • Age 18 years or older
  • Karnofsky performance status = 60 (see Appendix A)
  • Participants may have had any extent of prior surgery and/or chemotherapy.
  • Must be able to speak and comprehend English
  • Ability to understand and willingness to sign a written informed consent document
  • The effects of proton radiation therapy on the developing human fetus are known to be teratogenic. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and 4 months after completion of proton therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study treatment, and 4 months after completion of proton therapy.
  • Life expectancy greater than or equal to 6 months.

Exclusion Criteria:

  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant or lactating women are excluded from this study because radiation is known to have teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiation therapy, breastfeeding should be discontinued if the mother is treated with radiation therapy.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03286335

Locations

  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02214

Sponsors and Collaborators

Massachusetts General Hospital

More Information

No publications provided

Responsible Party: Principal Investigator Massachusetts General Hospital Helen A. Shih, MD Shih, Helen A, MD
ClinicalTrials.gov Identifier: NCT03286335
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Massachusetts General Hospital:

Brain Tumor

Additional relevant MeSH terms:

Brain Neoplasms

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on February 25, 2021