Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas

NCT ID: NCT01024907

Last Updated: 2020-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-17
• Study Completion Date: 2014-02-28

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

proton beam radiation therapy

Intervention Type: RADIATION

Undergo radiation

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary study

questionnaire administration

Intervention Type: OTHER

Ancillary study

Interventions

proton beam radiation therapy

Undergo radiation

Intervention Type: RADIATION

quality-of-life assessment

Ancillary study

Intervention Type: PROCEDURE

questionnaire administration

Ancillary study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Lustig

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23388559 (View on PubMed)

Other Identifiers

NCI-2009-01442

Identifier Type: -

Identifier Source: secondary_id

UPCC 08309

Identifier Type: -

Identifier Source: org_study_id