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

Primary Purpose

Brain Tumor

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Proton Radiation

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring Brain Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton Radiation

Arm Description

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

Outcomes

Primary Outcome Measures

Duration of Local Control

The duration of local control will be measured from the start date of protocol radiation until the date of progressive disease. Local control is defined as the lack of tumor growth as determined by a brain MRI (magnetic resonance imaging). This will include tumors that appear unchanged in size as compared to the baseline pre-radiation scan and also tumors that appear slightly reduced in size as may occur in response to radiation therapy. Inflammation secondary to radiation therapy can radiographically mimic subtle disease progression and may need to be confirmed with serial imaging. Progression is defined as an increase in the size of the tumor, a significant increase in T2/FLAIR non-enhancing lesion on sable or increasing doses of corticosteroids compared to baseline, the appearance of any new lesion, clear clinical deterioration not attributable to any other cause apart from the tumor, or failure to return for evaluation due to death or deteriorating condition.

Secondary Outcome Measures

Quality of Life Assessment EORTC-QLQ-C30

Quality of life in relation to overall physical functioning will be assessed using the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ). Overall functioning will be assessed at baseline and follow-up evaluations using EORTC-QLQ-C30. Mixed effects models will be used to analyze the repeated measures of EORTC-QLQ with participant-specific intercepts and slopes assumed as random effects. Tumor type will be modeled as fixed effects in order to estimate quality of life changes over time among participants with each benign and malignant diagnosis.

Quality of Life Assessment EORTC-QLQ-BN20

Quality of life in relation to symptoms specific to brain cancer will be assessed using the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ). Brain cancer-specific symptoms will be assessed at baseline and follow-up evaluations using EORTC-QLQ-BN20. Mixed effects models will be used to analyze the repeated measures of EORTC-QLQ with participant-specific intercepts and slopes assumed as random effects. Tumor type will be modeled as fixed effects in order to estimate quality of life changes over time among participants with each benign and malignant diagnosis.

Quality of Life Assessment HADS

State anxiety and depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS screens for mood disorders in medically ill participants; it focuses on subjective rather than physical symptoms, which may be confounded with illness. Mixed effects models will be used to analyze the repeated measures of HADS with participant-specific intercepts and slopes assumed as random effects. Tumor type will be modeled as fixed effects in order to estimate mood changes over time among participants with each benign and malignant diagnosis.

Vision Loss

Those participants determined to have had proton radiation exposure to any part of the optic pathway that could potentially affect vision will undergo standard afferent neuro-ophthalmological evaluation, which includes tests of visual acuity, color perception, pupillary function, visual field testing, and optic disc appearance. Participants with any tumor type will be evaluable for visual outcome if the battery of neuro-ophthalmology evaluation were performed at baseline. Testing will be discontinued if the participant becomes blind. The cumulative incidence of developing vision loss among evaluable participants will be analyzed with failure defined as decline in one or more of the vision function tests and with competing risks of progressive disease and death.

Ototoxicity

For participants with proton radiation exposure to the skull base audiologic system, standard audiologic testing will be performed, unless poor hearing inadequate for useful function is present at baseline. Testing will be discontinued if the participant becomes deaf. Participants with any tumor type will be evaluable for hearing outcome if audiology evaluation were performed at baseline. The cumulative incidence of developing ototoxicity among evaluable participants will be analyzed with failure defined as significant decrease in Pure Tone Average or/and Word Recognition Score and with competing risks of progressive disease and death

Neuroendocrine dysfunction

Participants will be candidates for neuroendocrine testing if they were determined to have any radiation exposure to the hypothalamus or pituitary gland or to have a target lesion within 2 cm of either of these normal structures, unless panhypopituitarism is present at baseline. Participants with any tumor type will be evaluable for endocrine outcome if neuroendocrine evaluation were performed at baseline. The cumulative incidence of developing neuroendocrine dysfunction among evaluable participants will be analyzed with failure defined as any hormonal deficiency confirmed by test criteria and with competing risks of progressive disease and death.

Neurocognitive effects

Participants with any tumor type will be evaluable for neurocognitive analysis if the optional neuropsychological evaluation were performed at baseline and/or at least one follow-up. Mixed effects models will be used to analyze the repeated measures of intelligence, language, visuospatial/motor functioning, learning/memory and attention/executive functioning, with participant-specific intercepts and slopes assumed as random effects. Tumor and treatment characteristics may be modeled as fixed effects in order to estimate their effects on neurocognitive changes over time.

Alopecia

Participants with any tumor type will be evaluable for alopecia unless they are virtually bald at baseline and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Maximal hair loss will be documented between the last week of radiation and 4 weeks later, while permanent hair loss will be defined at 2 years post-treatment.

CD4 count

Participants with any tumor type will be evaluable for CD4 analysis if they were to consent to the optional assessment of CD4 count. The worst grade of CD4 count will be defined using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 during the short term (on-treatment and 1 to 3 months post-radiation) and long term (6 months to 2 years post-radiation).

Full Information

NCT ID

NCT03286335

First Posted

September 12, 2017

Last Updated

August 17, 2020

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03286335

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Recruiting

Study Start Date

September 26, 2018 (Actual)

Primary Completion Date

September 30, 2025 (Anticipated)

Study Completion Date

September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This research study is studying Proton Radiation as a possible treatment for brain tumor. The radiation involved in this study is: -Proton Radiation

Detailed Description

The main purpose of this study is to see how well the tumor is responding to the Proton Radiation up to 5 years after the participant receive it. The investigators are also looking for how this type of radiation affects the quality of life as well as any type of side effect the participant may have after the radiation is administered. The FDA (the U.S. Food and Drug Administration) has not approved Proton Radiation for this specific disease but it has been approved for other uses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Tumor

Keywords

Brain Tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Proton Radiation

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Proton Radiation

Intervention Description

Radiation treatment

Primary Outcome Measure Information:

Title

Duration of Local Control

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Quality of Life Assessment EORTC-QLQ-C30

Description

Time Frame

2 years

Title

Quality of Life Assessment EORTC-QLQ-BN20

Description

Time Frame

2 Years

Title

Quality of Life Assessment HADS

Description

Time Frame

2 Years

Title

Vision Loss

Description

Time Frame

2 years

Title

Ototoxicity

Description

Time Frame

2 years

Title

Neuroendocrine dysfunction

Description

Time Frame

2 years

Title

Neurocognitive effects

Description

Time Frame

2 years

Title

Alopecia

Description

Time Frame

2 years

Title

CD4 count

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tarin Grillo

Phone

617-724-3661

TGRILLO@mgh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helen A Shih, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02214

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tarin Grillo

Phone

617-724-3661

TGRILLO@mgh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Helen A Shih, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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