Table 1 Summary of RRCTs

Primary objective

To examine the feasibility of a multi-centre prospective RRCT evaluating alternating oxaliplatin and irinotecan doublet schedules versus continuous clinician choice doublet chemotherapy during initial treatment of metastatic colorectal cancer

To determine the overall survival impact of an additional six cycles of post-radiation temozolomide following the current standard of concurrent chemoradiation and six cycles of temozolomide

To compare the incidence of cognitive decline in elderly patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate versus enzalutamide

Study design

Phase II open-label, multi-centre, registry-based randomised controlled trial

Phase III open-label, multi-centre, registry-based randomised controlled trial

Phase IIII

Prospective, open-label, multi-centre, registry-based randomised clinical trial

Population

Patients diagnosed with treatment-naïve metastatic colorectal cancer (mCRC) deemed by their treating clinician to be fit for doublet chemotherapy

Newly diagnosed patients with histologically confirmed glioblastoma (WHO grade IV) and radiologically stable or responding disease (as per RANO criteria) following concurrent chemoradiation and six cycles of post-radiation temozolomide

Men aged 75 years or older with mCRPC appropriate for treatment with enzalutamide or abiraterone acetate

Randomisation and treatment arms

Patients randomised in a 1:1 ratio to one of two treatment arms: alternating cycles of oxaliplatin and then irinotecan doublet chemotherapy (experimental arm) versus continuous doublet chemotherapy (control arm).

Patients randomised in a 1:1 ratio after completing concurrent chemoradiation and six cycles of post-radiation temozolomide: observation (control arm) versus six further cycles (experimental arm) of post radiation temozolomide chemotherapy.

Participants stratified according to previous docetaxel treatment (yes/no) and randomised in a 1:1 ratio to enzalutamide versus abiraterone acetate

Primary endpoint

Progression free survival

Overall survival

Cognitive function

Secondary endpoints

Efficacy and toxicity by collecting data from the TRACC registry

Progression free survival, adverse events and the necessity for temozolomide dose modification to be determined by data entered into the BRAIN registry

Depression, falls and serious adverse events determined by data recorded in the ePAD registry