Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer: a Multicentre, Open-label, Randomised Pragmatic Clinical Trial (SHAPERS)

NCT06052332 NA RECRUITING

The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.

Details

Lead sponsor	Jules Bordet Institute
Phase	NA
Status	RECRUITING
Enrolment	230
Start date	2024-02-07
Completion	2033-12

Conditions

• Locally Advanced Rectal Cancer
• Older People

Interventions

• Short course radiotherapy
• Adjuvant chemotherapy (optional)
• Total mesorectal excision
• Total neoadjuvant therapy
• Long course chemoradiotherapy

Primary outcomes

• Overall survival — At 3 years after randomisation
  Overall survival (OS) will be calculated from randomisation to death from any cause.
• Progression-free survival — At 3 years after randomisation
  Progression-free survival (PFS) will be calculated from randomisation to any of the following events: unresectable tumour due to local tumour progression, R2 resection of the primary tumour, loco-regional recurrence after an R0/R1 resection, distant metastases, or death from any cause.
• Any grade peripheral sensory neuropathy — At 3 years after randomisation
  Any grade peripheral sensory neuropathy as assessed by the investigator according to the NCI-CTCAE v5.0 will be analysed.
• Grade ≥3 toxicities during treatment — At 3 years after randomisation
  Grade ≥3 toxicities during treatment (i.e., from the 1st day of treatment until the EOT visit) as assessed by the investigator according to the NCI-CTCAE v5.0 will be analysed.

Countries

Belgium