Protocol title: Capecitabine ON Temozolomide Radionuclide therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study
Study Chairs: A/Prof. Nick Pavlakis (Royal North Shore Hospital, St Leonards NSW); and Prof. J Harvey Turner (Fremantle Hospital, The University of WA, Freemantle WA)
Associate Oncology Program Manager: Eric Tsobanis
Trial Coordinator: Brad Green
Contact Email: firstname.lastname@example.org
Detailed information available on: Australian and New Zealand Clinical Trials Registry – CONTROL NETs
Trial Newsletter: None to date
The pilot phase of CONTROL NETS has been generously supported by a donation by the Unicorn Foundation. The non-carrier added Lutetium-177 and DOTA-octreotate used in the study will be supplied by Australian Nuclear Science and Technology Organisation.
Aim: To determine the relative activity of capecitabine and temozolomide (CAPTEM)/ 177Lu-Octreotate peptide receptor radionuclide therapy (PRRT) in biopsy-proven, low to intermediate grade, unresectable, metastatic 68Ga-octreotate PET-avid pancreatic and midgut Neuroendocrine Tumours (NETs). To inform future comparative phase III randomised controlled trials (RCTs) to determine the optimal therapies in pancreatic and midgut NETs.
Background: NETs are a heterogeneous group of malignancies that can arise at any site in the gastrointestinal tract, that are known by their ability to over express somatostatin receptors. Originally called carcinoid tumours, these tumours are rising in incidence. In patients with incurable disease, several systemic options have demonstrated activity but few have been compared in prospective, RCTs. PRRT and CAPTEM have shown promising activity in initial single arm trials.
Study Design and Methods: CONTROL NETs is two non-comparative parallel group phase II randomised open label trials of PRRT and CAPTEM in two cohorts of NET patients. Cohort A is comprised of patients with low to intermediate grade pancreatic NETs (pNETs) randomised to receive PRRT + CAPTEM or CAPTEM alone. Cohort B is comprised of patients with low to intermediate grade midgut NETs (mNETs) randomised to receive PRRT + CAPTEM or PRRT alone. In Cohort A, the control arm is CAPTEM and in Cohort B, the control arm is PRRT. The randomised design with a reference control arm is required due to the heterogeneity in historical data for this study population.
Randomisation will be performed using the method of minimisation.
In each cohort, patients will be stratified in a 2:1 ratio (PRRT+CAPTEM: control) by:
- Previous systemic therapy regimens (<1 v 2)
- WHO tumour grade:
- Low Grade — G1 (Ki67<2% (mitotic count <2)) vs.
- Intermediate Grade – G2 (Ki67 3-20% (mitotic count 2-20))
- Visceral only vs. visceral with bone metastases
- Treating institution
The pilot phase of CONTROL NETS has been generously supported by a donation by the Unicorn Foundation. The non-carrier added Lutetium-177 and DOTA-octreotate used in the study will be supplied by Australian Nuclear Science and Technology Organisation (ANSTO).
To view the study schema click here.