Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas

Recurrent Adult Brain Tumor Clinical Trial

Official title:

Proton Radiation for Low Grade Gliomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024907
• Other study ID #: UPCC 08309
• Secondary ID: NCI-2009-01442
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 17, 2009
• Est. completion date: February 2014

Study information

• Verified date: December 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Brain Stem Glioma
• Adult Brain Tumor
• 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
• Astrocytoma
• Brain Neoplasms
• Ependymoma
• Glioma
• Hemangiopericytoma
• Meningioma
• Oligodendroglioma
• Pinealoma
• Recurrent Adult Brain Tumor

Intervention

Radiation:
• proton beam radiation therapy
Undergo radiation

Procedure:
• quality-of-life assessment
Ancillary study

Other:
• questionnaire administration
Ancillary study

Locations

Country	Name	City	State
United States	Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (phase I)
Primary	Acute toxicity as assessed by NCI CTC version 3.0 (phases I and II)		60 days (phase I) or 90 days (phase II) from completion of radiation therapy
Secondary	Late toxicity as graded according to the RTOG/EORTC late morbidity scoring system (phases I and II)
Secondary	Fatigue as assessed by the Brief Fatigue Inventory (phases I and II)		Pre-radiation, mid-treatment, and post-radiation; at 3, 6, 9, and 12 months post-radiation; and then every 6 months
Secondary	Cumulative total dose to normal brain tissue (phase II)
Secondary	Progression-free survival (phases I and II)
Secondary	Overall survival (phases I and II)
Secondary	Adverse events as assessed by NCI CTCAE version 3.0