BR14 - Concurrent & Adj. Chemo in non 1p/19q deleted anaplastic glioma

• Research type

  Research Study

• Full title

  Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON Intergroup trial.

• IRAS ID

  1036

• Contact name

  Sara Erridge

• Sponsor organisation

  EORTC (European Organisation for Research and Treatment of Cancer)

• Eudract number

  2006-001533-17

• ISRCTN Number

  -

• Clinicaltrials.gov Identifier

  NCT00626990

• Research summary

  This trial is a follow up other EORTC studies (26981 & 26951) addressing the overall strategy of optimising the treatment of patients newly diagnosed with a type of brain tumour called anaplastic glioma with a particular feature (referred to as ??combined 1p/19q loss?) which can be determined from a sample of the tumour or blood.All patients in the trial will get standard treatment for their brain tumour, which is surgery followed by a course of radiotherapy. The trial investigates the best way to use the drug temozolomide (also known as temodal) in addition to this.The primary objectives of this trial are:?½ To assess whether radiotherapy given with a daily dose (tablet) of a drug called temozolomide (??concurrent temozolomide?) improves overall survival as compared to patients not having daily temozolomide with their radiotherapy.?½ To assess whether temozolomide chemotherapy given for up to a year after radiotherapy (??adjuvant temozolomide?) improves survival as compared to no adjuvant temozolomide After completion of all pre-treatment screening procedures, eligible patients will be randomised immediately after surgery to one of the 4 following treatment groups (??arms?):Arm 1 : Radiotherapy (RT) alone (and further treatment including chemotherapy at progression);Arm 2 : RT & concurrent temozolomide chemotherapy (CT);Arm 3 : RT adjuvant CT for 12 months;Arm 4 : RT & concurrent CT adjuvant CT;Approximately 800 patients will be registered, treated according to their allocated group, and followed-up to see how they respond to treatment in terms of the duration of survival, and also to collect information on any side effects and to observe patient-assessed quality of life.

• REC name

  Scotland A REC

• REC reference

  09/MRE00/53

• Date of REC Opinion

  2 Dec 2009

• REC opinion

  Further Information Favourable Opinion