Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

Titre officiel

Phase III Intergroup Study of Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

Sommaire:

JUSTIFICATION : La radiothérapie fait appel à des rayons X à haute énergie pour tuer les cellules tumorales. Les médicaments utilisés pour la chimiothérapie, comme le témozolomide, agissent de différentes façons pour stopper la multiplication des cellules tumorales, soit en les tuant soit en les empêchant de se diviser. On ignore encore si le témozolomide administré seul, la radiothérapie employée seule, ou encore l’association du témozolomide avec la radiothérapie est plus efficace dans le traitement du gliome anaplasique. OBJECTIF : Cet essai randomisé de phase III vise à comparer trois schémas thérapeutiques – le témozolomide seul, la radiothérapie seule, ou l’association des deux – pour déterminer le meilleur traitement chez des patients atteints d’un gliome anaplasique nouvellement diagnostiqué.

Description de l'essai

Primary Outcome:

  • Progression-free survival
Secondary Outcome:
  • Time to progression
  • Time to neurocognitive progression, assessed using the Hopkins Verbal Learning Test-Revised for Free Recall, Delayed Recall, and Delayed Recognition; the Controlled Oral Word Association test; and the Trail Making Test Part A or B
  • Overall survival
  • Objective tumour response defined as a complete response or partial response
  • Treatment-related adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
This study will be a randomized phase III for patients with newly diagnosed co-deleted 1p/19q anaplastic glioma or high risk low grade glioma. The trial will only enroll patients with 1p/19q co-deletion. This study includes two arms as described in the "Arms" section. A dynamic allocation procedure will be used to allocate an equal number of patients to different arms (Arms A:B = 1:1). This procedure will balance the marginal distributions of the stratification factors among arms. The stratification factors that will be used are cooperative groups (EORTC vs. all North American groups), age (≤ 50 vs. > 50), performance score (ECOG 0-1 vs. 2), and tumour grade (anaplastic glioma vs. low grade glioma). The primary goal is to determine whether patients who receive radiation therapy with concomitant temozolomide (TMZ) followed by adjuvant temozolomide (RT + TMZ --> TMZ) (Arm B) have a marginally better progression free survival (PFS) as compared with patients who receive radiation therapy followed by PCV chemotherapy (RT --> PCV)(Arm A). Secondary Goals: 1. Time to Progression
  • To determine whether patients who receive (RT + TMZ --> TMZ) have a significantly longer time to progression (clinical or radiographic progression) as compared with patients who receive radiation therapy followed by adjuvant PCV chemotherapy (RT --> PCV). 2. Correlation between exploratory biomarkers and survival
  • To determine whether there is a difference in survival based on t(1;19)(q10, p10) translocation status and MGMT promoter hypermethylation status. 3. Descriptive Comparisons of Additional Secondary Endpoints
  • To perform descriptive comparisons of additional secondary outcome endpoints, including overall survival, objective tumour response, prognostic factor analysis and quality of life. 4. Toxicity
  • To determine the toxicity of the treatment in each arm and perform descriptive comparisons. 5. Neurocognitive and Quality of Life (QOL) Effects
  • To determine the neurocognitive and QOL effects in patients treated on this protocol and correlate these results with outcome endpoints. 6. Banking of Biospecimens and Neuroimaging Studies
  • To store blood products (i.e., plasma, DNA and buffy coat), tumour tissue and MRI/CT images for future scientific investigations. After completion of study treatment, patients are followed every 12 weeks for 1 year, then every 4 months for 2 years and then every 6 months until progressive disease or until the end of study participation.

Voir cet essai sur ClinicalTrials.gov

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