Summary

This Phase III, randomized, open-label trial investigates the addition of temozolomide (concurrently and/or adjuvantly) to radiotherapy versus radiotherapy alone in adults with newly diagnosed non-1p/19q-deleted anaplastic glioma. Participants were assigned to four arms: RT alone; RT + concurrent temozolomide; RT + adjuvant temozolomide; or both. The primary endpoint is overall survival; secondary outcomes include progression-free survival, cognitive and neurological decline, toxicity, and quality of life. The second major objective is to identify patients most likely to benefit from this specific treatment based on molecular markers analysed on the tumour specimen previously resected which will ultimately allow the development of new treatments more specific for each patients tumour characteristics.

Study Chair

Professor Anna Nowak

Coordinating Centre

NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: catnon.study@sydney.edu.au

Design

Phase III, multi-centre, randomised, open-label, parallel arms

Cancer Type

Glioma (G3)

Intervention

Arm 1- Radiotherapy only

Arm 2 – Radiotherapy and concomitant Temozolomide chemotherapy

Arm 3 – Radiotherapy and adjuvant Temozolomide chemotherapy

Arm 4 – Radiotherapy, concomitant Temozolomide chemotherapy and adjuvant Temozolomide chemotherapy.

Publications

Interim results from the CATNON trial (EORTC study 26053-22054) of treatment with concurrent and adjuvant temozolomide for 1p/19q non-co-deleted anaplastic glioma: a phase 3, randomised, open-label intergroup study.
van den Bent, Martin J., et al
https://doi.org/10.1016/S0140-6736(17)31442-3

Adjuvant and concurrent temozolomide for 1p/19q non-co-deleted anaplastic glioma (CATNON; EORTC study 26053-22054): second interim analysis of a randomised, open-label, phase 3 study.
van den Bent, Martin J., et al.
https://doi.org/10.1016/S1470-2045(21)00090-5

Temozolomide and Radiotherapy versus Radiotherapy Alone in Patients with Glioblastoma, IDH-wildtype: Post Hoc Analysis of the EORTC Randomized Phase III CATNON Trial.
Tesileanu, C. Mircea S., et al.
https://doi.org/10.1158/1078-0432.CCR-21-4283

PROGNOSTIC SIGNIFICANCE OF GENOME-WIDE DNA METHYLATION PROFILES WITHIN THE RANDOMISED, PHASE 3, EORTC CATNON TRIAL ON NON-1P/19Q DELETED ANAPLASTIC GLIOMA.
C M S Tesileanu, M J van den Bent, M Sanson, W Wick, A A Brandes, P M Clement, S C Erridge, M A Vogelbaum, A K Nowak, J F Baurain, W P Mason, H Wheeler, O L Chinot, S Gill, M Griffin, L Rogers, W Taal, R Rudà, M Weller, C McBain, M E van Linde, T S Sabedot, Y Hoogstrate, A von Deimling, I de Heer, W F J van IJcken, R W W Brouwer, K Aldape, R B Jenkins, H J Dubbink, J M Kros, P Wesseling, K J Cheung, V Golfinopoulos, B G Baumert, T Gorlia, H Noushmehr, P J French.
Neuro-Oncology. Volume 23, Issue 9, September 2021, Pages 1547–1559.
Published online 29 April 2021.
Article available on https://doi.org/10.1093/neuonc/noab088.

Date of activation:

Expected final accrual date:

Purpose of the study

ELIGIBILITY CRITERIA

Inclusion Criteria

Exclusion Criteria

Patient population

Primary outcome

Intervention

Arm 1- Radiotherapy only

Arm 2 – Radiotherapy and concomitant Temozolomide chemotherapy

Arm 3 – Radiotherapy and adjuvant Temozolomide chemotherapy

Arm 4 – Radiotherapy, concomitant Temozolomide chemotherapy and adjuvant Temozolomide chemotherapy.

Secondary outcome

13 Participating Sites

83 Recruitment Target

Trial Locations

VIC

Location:

NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia

Trials & Research

Your donations to our Brain Tumour Research make a real difference