Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas
Primary Purpose
Adult Brain Tumor, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
proton beam radiation therapy
quality-of-life assessment
questionnaire administration
Sponsored by
About this trial
This is an interventional treatment trial for Adult Brain Tumor
Eligibility Criteria
Inclusion
- Patients with histologically confirmed diagnosis of low grade glioma of the CNS
- Patients with WHO grade II; may be symptomatic; including patients who are being followed and have radiographic expression
- Patients must have a Karnofsky Performance Status of >= 60
- Patients must be able to provide informed consent
Patients must have adequate bone marrow function:
- WBC >= 4000/mm^3
- platelets >= 100,000 mm^3
- Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc); Hysterectomy or menopause must be clinically documented
Exclusion
- Patients who have had prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
- Patients with the following histologies:
gliomatosis cerebrei, WHO III or IV gliomas
- Patients who have had any prior Radiation treatment
- Patients who have had any chemotherapy administered within 30 days of the planned radiation treatment start date
- Pregnant women, women planning to become pregnant and women that are nursing
- Patients who are actively being treated on any other therapeutic research study
Sites / Locations
- Abramson Cancer Center of The University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm I
Arm Description
Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
Feasibility (phase I)
Acute toxicity as assessed by NCI CTC version 3.0 (phases I and II)
Secondary Outcome Measures
Late toxicity as graded according to the RTOG/EORTC late morbidity scoring system (phases I and II)
Fatigue as assessed by the Brief Fatigue Inventory (phases I and II)
Cumulative total dose to normal brain tissue (phase II)
Progression-free survival (phases I and II)
Overall survival (phases I and II)
Adverse events as assessed by NCI CTCAE version 3.0
Full Information
NCT ID
NCT01024907
First Posted
December 2, 2009
Last Updated
December 8, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01024907
Brief Title
Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas
Official Title
Proton Radiation for Low Grade Gliomas
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 17, 2009 (Actual)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying the best way to give proton beam radiation therapy and to see how well it works in treating patients with low grade gliomas.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of proton beam radiation therapy in patients with low grade gliomas. (Phase I)
SECONDARY OBJECTIVES:
I. To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of low grade gliomas. (Phase II) II. To assess acute side effects from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of low grade gliomas. (Phase II) III. To compare the dose distribution to tumor and surrounding normal structures using DVH's (Dose Volume Histograms) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. (Phase II) IV. To monitor the rates of local control, overall and disease specific survival using proton radiotherapy. (Phase II) V. To evaluate the time to progression of low grade gliomas treated with protons. (Phase II) VI. To evaluate the incidence and severity of fatigue in low grade glioma treated with protons. (Phase II) VII. To evaluate the effect of proton beam radiation on neurocognitive outcome in patients with low grade glioma. (Phase II) VIII. To evaluate the quality of life in patients treated for low grade glioma. (Phase II)
OUTLINE: Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Brain Tumor, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma, Adult Ependymoma, Adult Grade II Meningioma, Adult Melanocytic Lesion, Adult Meningeal Hemangiopericytoma, Adult Mixed Glioma, Adult Oligodendroglioma, Adult Pineal Gland Astrocytoma, Adult Pineocytoma, Recurrent Adult Brain Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Radiation
Intervention Name(s)
proton beam radiation therapy
Intervention Description
Undergo radiation
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Description
Ancillary study
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary study
Primary Outcome Measure Information:
Title
Feasibility (phase I)
Title
Acute toxicity as assessed by NCI CTC version 3.0 (phases I and II)
Time Frame
60 days (phase I) or 90 days (phase II) from completion of radiation therapy
Secondary Outcome Measure Information:
Title
Late toxicity as graded according to the RTOG/EORTC late morbidity scoring system (phases I and II)
Title
Fatigue as assessed by the Brief Fatigue Inventory (phases I and II)
Time Frame
Pre-radiation, mid-treatment, and post-radiation; at 3, 6, 9, and 12 months post-radiation; and then every 6 months
Title
Cumulative total dose to normal brain tissue (phase II)
Title
Progression-free survival (phases I and II)
Title
Overall survival (phases I and II)
Title
Adverse events as assessed by NCI CTCAE version 3.0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion
Patients with histologically confirmed diagnosis of low grade glioma of the CNS
Patients with WHO grade II; may be symptomatic; including patients who are being followed and have radiographic expression
Patients must have a Karnofsky Performance Status of >= 60
Patients must be able to provide informed consent
Patients must have adequate bone marrow function:
WBC >= 4000/mm^3
platelets >= 100,000 mm^3
Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc); Hysterectomy or menopause must be clinically documented
Exclusion
Patients who have had prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
Patients with the following histologies:
gliomatosis cerebrei, WHO III or IV gliomas
Patients who have had any prior Radiation treatment
Patients who have had any chemotherapy administered within 30 days of the planned radiation treatment start date
Pregnant women, women planning to become pregnant and women that are nursing
Patients who are actively being treated on any other therapeutic research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Lustig
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of The University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23388559
Citation
Maquilan G, Grover S, Alonso-Basanta M, Lustig RA. Acute toxicity profile of patients with low-grade gliomas and meningiomas receiving proton therapy. Am J Clin Oncol. 2014 Oct;37(5):438-43. doi: 10.1097/COC.0b013e31827de86b.
Results Reference
derived
Learn more about this trial
Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas
We'll reach out to this number within 24 hrs