Patients with NSCLC who are expected to live longer than three months and are fit to receive radical radiotherapy (radiotherapy given with curative intent) will be eligible to participate.
All trial participants will receive 20 doses (called fractions) of radiotherapy.
The maximum safe dose of radiotherapy for the oesophagus (gullet) is not currently known.
The trial will be split into two parts: The findings of both parts of this study will determine whether increasing the dose of radiotherapy for NSCLC patients is a tolerable, safe and effective treatment.
We’ll be sure to keep you updated every step of the way.
The I-START trial is designed to determine the highest doses of radiotherapy that can safely be used in locally advanced non-small cell lung cancer (NSCLC).
“go Balto assists us in combining process improvements with broad integrations, a strategy that leverages ‘best of breed’ applications in the e Clinical stack to realize gains in operational efficiencies, ultimately resulting in shorter timelines and cost savings for our customers.” Benefiting from go Balto Activate’s robust library of country-specific workflows and management-based approach to site activation, INC Research initiates and manages thousands of investigational sites on a global basis per year.
With its employees leveraging the Activate system worldwide, INC Research manages small to large complex studies ranging from a single country to up to 40 or more.
If the results are positive then this new treatment may be compared against the best currently available standard treatments in a future larger randomised (Phase III) trial.
go Balto, a provider of cloud-based clinical study startup solutions, announced results from its ongoing partnership with INC Research, a global CRO and pioneer in the implementation of go Balto’s end-to-end study startup platform to accelerate delivery of phase I to IV clinical trials for global biopharmaceutical customers.
As a longstanding go Balto customer, INC Research uses Activate to efficiently manage the end-to-end start-up process for more than 150 pharmaceutical sponsors.