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Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas

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ClinicalTrials.gov Identifier: NCT01024907
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Study Description
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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.


Condition or disease Intervention/treatment Phase
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 Radiation: proton beam radiation therapy Procedure: quality-of-life assessment Other: questionnaire administration Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proton Radiation for Low Grade Gliomas
Actual Study Start Date : December 17, 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I
Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.
 Radiation: proton beam radiation therapy
Undergo radiation

Procedure: quality-of-life assessment
Ancillary study

Other: questionnaire administration
Ancillary study


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility (phase I)
  2. 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 Measures :
  1. Late toxicity as graded according to the RTOG/EORTC late morbidity scoring system (phases I and II)
  2. 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 ]
  3. Cumulative total dose to normal brain tissue (phase II)
  4. Progression-free survival (phases I and II)
  5. Overall survival (phases I and II)
  6. Adverse events as assessed by NCI CTCAE version 3.0

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    1. WBC >= 4000/mm^3
    2. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024907


Locations
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United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Robert Lustig Abramson Cancer Center of the University of Pennsylvania
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01024907    
Other Study ID Numbers: UPCC 08309
NCI-2009-01442
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Glioma
Brain Neoplasms
Astrocytoma
Meningioma
Ependymoma
Oligodendroglioma
Hemangiopericytoma
Solitary Fibrous Tumors
Pinealoma
Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue