NCT02417662

Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer

Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer. a Randomised Phase III Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial will assess the addition of stereotactic ablative radiotherapy (SABR) to standard anti-cancer therapy (SACT) in patients with oligometastatic non-small cell lung cancer. Patients will be randomised to receive either standard treatment alone (SACT) or standard treatment with conventional radiotherapy (RT) and SABR.

Detailed description

SARON is a confirmatory phase III study examining the efficacy and safety of stereotactic ablative radiotherapy (SABR) and conventional radiotherapy (RT) alongside standard chemotherapy in patients with oligometastatic non-small cell lung cancer. Current treatment for this group of patients is systemic anti-cancer therapy. The choice of SACT is determined by the treating clinician and will be supplied from hospital commercial stock, and prepared and administered according to institutional guidelines. There is sufficient evidence regarding the safety of SABR, its effect on local control and a possible impact on overall survival. This trial will further examine overall survival, progression free survival and local control, as well as toxicity, feasibility, patient reported outcomes and health resource use. There will be a feasibility analysis performed after 50 patients have been randomised. This will assess the practicality of achieving recruitment targets, logistics of delivering the experimental treatment and the potential for contamination (as patients may seek SABR outside of the trial if randomised to the non SABR arm). There will also be a parallel thoracic SABR safety and feasibility study after recruitment and treatment of 20 patients with thoracic metastases. This is a multicentre randomised phase III study based on patients with oligometastatic NSCLC. Trial arms: Control Arm: systemic anti-cancer therapy alone (SACT) Experimental Arm: SACT plus radical RT to primary and SABR and/or SRS to metastases

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	Radical Radiotherapy (Conventional RT and SABR)	Radical radiotherapy (conventional or SABR) to primary and SABR to the metastases
OTHER	Non-investigational SACT	There is no intervention in the control group, patients will receive SACT. The choice of SACT is determined by the treating clinician and will be supplied from hospital commercial stock, and prepared and administered according to institutional guidelines.

Timeline

• Start date: 2016-08-19
• Primary completion: 2025-08-01
• Completion: 2028-08-01
• First posted: 2015-04-16
• Last updated: 2024-10-28

Locations

19 sites across 1 country: United Kingdom