Natural History of Brain Function, Quality of Life, and Seizure Control in Patients With Brain Tumor Who Have Undergone Surgery

Completed

Conditions studied: Adult Diffuse Astrocytoma, Adult Mixed Glioma, Adult Oligodendroglioma, Cognitive/Functional Effects, Neurotoxicity, Psychosocial Effects of Cancer and Its Treatment, Seizure

In brief

This trial studies the natural history of brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery. Learning about brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery may help doctors learn more about the disease and find better methods of treatment and on-going care.

Key facts

Study ID

NCT01417507

Run by

Radiation Therapy Oncology Group

People needed

82

Starts

2011-10-01

Expected to finish

2014-12-01

Last updated by the study team

2015-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Central pathology confirmed diagnosis of supratentorial grade II oligodendroglioma, astrocytoma, or mixed oligoastrocytoma prior to step 2 registration
• No multifocal disease, based upon the following minimum diagnostic work-up:
• History/physical examination, including neurologic examination, within 84 days prior to step 2 registration
• Brain MRI with and without contrast within 84 days prior to Step 2 registration (Note: MRI 70 days after surgery is preferred and highly encouraged)
• The patient must be within one of the following categories:
• Maximal safe resection with minimal residual disease defined as follows:
• Removal of T2/fluid-attenuated inversion recovery (FLAIR) abnormalities thought to be primarily tumor, with a residual ≤ 2 cm maximal tumor diameter/T2 FLAIR abnormality on MRI to be done within 84 days post-operatively
• If there is > 2 cm post-operative residual T2/FLAIR abnormality and the neurosurgeon believes this represents edema and not primarily tumor, the neurosurgeon is encouraged to repeat imaging within the allowed study period (up to 84 days post-operatively) to confirm resolution of edema
• MRI at the time of enrollment must document a ≤ 2 cm residual maximal tumor diameter/T2 FLAIR abnormality
• Patients who required a second surgery to obtain a maximal safe resection will be eligible if the second surgery is performed within 84 days of the initial diagnostic procedure
• Age < 40 (any extent of resection)
• Age < 50 and preoperative tumor diameter < 4 cm (any extent of resection)
• Karnofsky performance status ≥ 80%
• No prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
• Must be able to undergo MRI of the brain with gadolinium
• No plans for adjuvant radiotherapy or chemotherapy after surgery
• No more than 84 days (12 weeks) since prior surgery
• No brain tumor recurrence
• No prior brain tumor surgery, radiation therapy and/or chemotherapy

Where it is running

• The Kirklin Clinic at Acton Road — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Providence Hospital — Mobile, Alabama, United States
• Arizona Oncology Services Foundation — Phoenix, Arizona, United States
• Arizona Oncology-Deer Valley Center — Phoenix, Arizona, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Florida Hospital — Orlando, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Queen's Medical Center — Honolulu, Hawaii, United States
• University of Hawaii — Honolulu, Hawaii, United States
• Hawaii Medical Center East — Honolulu, Hawaii, United States
• Leeward Radiation Oncology Center — ‘Ewa Beach, Hawaii, United States
• Evanston CCOP-NorthShore University HealthSystem — Evanston, Illinois, United States
• Covenant Medical Center — Waterloo, Iowa, United States
• Norton Health Care Pavilion - Downtown — Louisville, Kentucky, United States
• Norton Suburban Hospital — Louisville, Kentucky, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Barnes West County Hospital — St Louis, Missouri, United States
• Billings Clinic — Billings, Montana, United States
• The Nebraska Medical Center — Omaha, Nebraska, United States
• University of Rochester — Rochester, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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