Comparing Standard and Total Neoadjuvant Therapy in People 70 and Older With Advanced Rectal Cancer

What this Trial Is About

Researchers are evaluating standard neoadjuvant treatment options for patients aged 70 years or older with high-risk stage II and stage III rectal cancer in a multicentre, open-label, randomized clinical trial called SHAPERS. The study compares conventional neoadjuvant therapy with total neoadjuvant therapy TNT to understand their safety and effectiveness for this older patient group. Participants are randomly assigned to one of two groups. The conventional treatment group receives either short course radiotherapy followed by surgery or watch & wait, with optional adjuvant chemotherapy, or long course chemoradiotherapy followed by surgery or watch & wait, also with optional adjuvant chemotherapy. The TNT group receives one of several treatment regimens decided by the investigator before randomization, including combinations of short course radiotherapy, oxaliplatin-based chemotherapy lasting up to 18 weeks, and chemoradiotherapy, followed by surgery or watch & wait. During the study, participants undergo treatments as assigned and are monitored for outcomes including overall survival, progression-free survival, peripheral sensory neuropathy, and severe toxicities over 3 years after randomization. Researchers will gather information about treatment effects, side effects, and patient survival to compare the two approaches. The study includes follow-up assessments to track these outcomes and participant safety throughout the trial duration.

Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer