Newly Diagnosed Anaplastic Glioma (AA/AO/AOA) Without 1p/19q Deletion : RTOG 0834

A PHASE III TRIAL ON CONCURRENT AND ADJUVANT TEMOZOLOMIDE CHEMOTHERAPY IN NON 1/19Q DELETED ANAPLASTIC GLIOMA (IRB #22077)


PURPOSE OF THE RESEARCH: The purpose of this research trial is to determine whether the addition of temozolomide treatment to radiotherapy (concomitant treatment) or the addition of temozolomide treatment after completion of radiotherapy on 5 days out of 28 days for 12 months (adjuvant treatment) will improve results of the radiotherapy treatment for patients stricken with a brain tumor (anaplastic glioma). 

RECRUITMENT: The target population for this research trial are patients with Anaplastic glioma (either an anaplastic astrocytoma, an anaplastic oligoastroctyoma, or an anaplastic oligodendroglioma - which are all types of brain tumors), who require further treatment after having undergone surgery / biopsy for this tumor. Cedars-Sinai Department of Pathology will require at least two tumor blocks (or more) to perform the required analysis. Tissue analysis will include analysis of the MGMT gene, which will help investigators understand the role of this specific gene in response to therapy. Patients who do not have tumor blocks available will not be eligible to participate. This analysis will be completed during the screening process. 

CONSENTING: Participants will be identified by their doctor. Once referred, participants will be informed of the details of this trial and will be reminded that participation is voluntary. Participants will be given ample time to ask questions, discuss participation with their family and decide if they want to participate. 

JOURNEY THROUGH THE RESEARCH: This is a Phase III, randomized trial. Before a subject is known to be eligible for this trial, they will have to sign a Screening Consent Form. This initial screening process for subjects in this trial entails gathering a piece of tissue taken from a previously performed surgery and sending it for 1p/19q analysis. These are tumor markers associated with the condition under study. Once patients are confirmed as being eligible in relation to the analysis done on their tissue sample, they will be asked to sign the main study consent form. At that point, patients will come into the clinic for another round of screening to determine if they are eligible to participate. The following assessments will take place: 

The screening/baseline evaluations include:

  • Review of medical history, current symptoms, physical exam (including neurological evaluation) 
  • Vital signs, blood pressure, height and weight 
  • Performance status, Mini mental status examination (MMSE), Quality of Life questionnaires 
  • Corticosteroid intake - Complete blood counts & Serum chemistry
  • MRI or contrast enhanced CT scan of the brain
  • Fresh frozen tumor material for translational research (optional) 

If subjects are confirmed as eligible to participate after this second screening, they will be randomly assigned to 1 of 4 treatment groups:

  • Group 1: Radiotherapy for 6-7 weeks.
  • Group 2 : Radiotherapy and temozolomide for a maximum of 49 days (7 weeks). 
  • Group 3: Radiotherapy for 6-7 weeks. Four weeks after radiotherapy, temozolomide will be administered for up to 12 months. 
  • Group 4: Radiotherapy and temozolomide for a maximum of 49 days (7 weeks). Four weeks after radiotherapy, temozolomide will be re-started for up to 12 months. 

Patients will come into the clinic on a weekly basis. A more detailed evaluation will take place at week 4, week 6 (= end of radiotherapy) and 4 weeks after the end of radiotherapy.

The following procedures will take place throughout the course of the subject’s participation in this trial and will vary depending on the treatment arm that the participant is assigned to:

  • Physical examination
  • Vital signs
  • Neurological evaluation
  • Review of adverse Events
  • Review of Performance status
  • Corticosteroids intake
  • MMSE (mini mental status exam) 
  • Quality of Life questionnaires
  • Complete blood count, all serum chemistries
  • MRI or contrast CT scan of the brain

All patients would have three monthly disease and status assessments after the end of radiotherapy, which include:

  • Physical exam and neurological evaluation
  • Corticosteroid intake
  • MMSE (mini mental status exam)
  • Quality of Life questionnaires
  • Performance status
  • Review of adverse events
  • Enhanced MRI or contrast CT scan of the brain
  • Cognitive exam 

Optional Sub-Studies:

  • Quality of Life / Neurocognitive: Patients who consent, will complete two questionnaires at the following time points - Before the start of treatment, 4 weeks after completing RT and every 3 months for the next 5 years. The questionnaires will ask patients about their quality of life since being diagnosed with a brain tumor. Additionally, a brief assessment to evaluate neurocognitive function will be performed at the first visit and every year thereafter. During this assessment, a test administrator will ask several questions to test neurocognitive functioning.
  • Collection of Tumor tissue and blood samples: As a part of the main study, archival tumor tissue and blood samples are being collected. For this sub-study, researchers are requesting to keep a left-over portion of the tumor tissue used to determine eligibility and collection of about 3 tablespoons of blood. Both of these samples will be collected after consenting and before start of treatment, to help researchers learn more about diseases and possible cures for diseases.

STANDARD OF CARE VS. RESEARCH-RELATED: All of the procedures involved in this trial are standard of care assessments. The patient / their insurance will be billed for all procedures and treatments in this study.

Surasak Phuphanich MD, FAAN
Director, Neuro-oncology Program
Phone: 310-423-8100
Email: groupmdnsi@cshs.org

Heather Chen
Program Coordinator
Phone: 310-428-6773
Email: groupmdnsi@cshs.org