N0577 CODEL: Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
This research is being done to compare the effectiveness of these three regimens in the treatment of anaplastic glioma, a type of brain tumor: 1) Radiotherapy (RT, radiation therapy) with temozolomide chemotherapy followed by additional temozolomide chemotherapy (RT + TMZ ? TMZ); 2) Radiotherapy followed by PCV chemotherapy [(RT ? PCV); PCV chemotherapy consists of three drugs, Matulane (procarbazine), Lomustine (CCNU) and Oncovin (vincristine)]; and 3)Temozolomide chemotherapy alone (TMZ alone).
Generally healthy adults over the age of 18 with the following may be eligible: Newly diagnosed anaplastic glioma and less than 3 months since surgery, Have not received treatment for this diagnosis, No other active cancers within the last 5 years, Normal laboratory test results, Not pregnant or nursing, and Willing and able to complete a neurocognitive test and return to the clinic for appointments.
Interested patients will first have their tumor reviewed by the study to confirm the 1p/19q co-deleted status. Upon confirmation, patients will be give the option to participate on the study. They will sign consent and undergo routine screening tests to determine if they can participate. If they are eligible, they will be randomly assigned, like drawing a name from a hat, to receive one of the following study regimens: 1) radiation therapy followed by chemotherapy, 2) Radiation therapy with Temozolomide followed by Temozolomide alone, or 3) Temozolomide alone. Neither the patient or their doctor will be able to choose which regimen they receive. Depending on the regimen, subjects will receive their study regimen for about 9 to 18 months. After completing the study regimen, subjects will be followed to monitor the tumor status and overall health.
10/16/2017 05:03 AM