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
Study of Radiotherapy with Adjuvant Drug versus Radiotherapy with PCV Chemotherapy in Patients with Glioma
Sponsor: NCI Alliance
Enrolling: Male and Female Patients
IRB Number: AAAR0376
U.S. Govt. ID: NCT00887146
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: Two different studies have been developed to treat people with anaplastic glioma brain tumors. Onetreatment research study requires a tumor that has the 1p/19q co-deletion tumor marker; the other does not. This treatment research study requires that the subject has a certain kind of tumor, one that is missing part of both chromosomes 1 and 19. These missing parts of chromosomes are called a tumor marker as they make the tumor distinct from other kinds of tumors. This tumor marker is called the 1p/19q co-deletion. Tumors with this 1p/19q co-deletion typically have a more favorable outcome than other types of anaplastic glioma or low grade glioma. The purpose of this study is to compare the effectiveness of 1) radiotherapy (RT, radiation therapy) with temozolomide chemotherapy followed by additional temozolomide chemotherapy (RT + TMZ TMZ); 2) or radiotherapy followed by PCV chemotherapy (RT PCV); PCV chemotherapy consists of three drugs,Matulane (procarbazine), Lomustine (CCNU) and Oncovin (vincristine); in the treatment of anaplasticglioma or low grade glioma, a type of brain tumor. In this study, the subject will get one of the twopossible treatments. The main question this research study will answer is: Do subjects survive for a longer period of time without the tumor progressing if they are treated with a combination of radiotherapy with temozolomide chemotherapy as compared to radiotherapy with PCV chemotherapy?
This study is closed
Andrew Lassman, MD
Do You Qualify?
Have you been diagnosed with glioma? Yes No
Have you had prior radiation therapy or chemotherapy for glioma? Yes No
You may be eligible for this study

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