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

Recruiting 230 enrolled Jules Bordet Institute

RandomizedParallel-groupOpen-labelHealth-services research

Summary

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.

Timeline

Start: 2024-02-07
Primary completion: 2029-12
Completion: 2033-12

Publications

Saude-Conde R, Vandamme T, De Backer M, Martinive P, Covas A, Deleporte A, Dermine A, Forget F, Geboes K, Gilliaux Q, Gokburun Y, Gonne E, Joye I, Lecomte S, Liberale G, Lybaert W, Moretti L, Mortier L, Mupingu Mwanawa S, Puleo F, Saad ED, Sinapi I, Annemans L, Buyse M, Sclafani F. Efficacy and safety of short-course radiotherapy versus total neoadjuvant therapy in older rectal cancer patients: a randomised pragmatic trial (SHAPERS). ESMO Gastrointest Oncol. 2024 Jun 5;4:100067. doi: 10.1016/j.esmogo.2024.100067. eCollection 2024 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	—	—
Subject	Oxaliplatin	Small molecule	—	—
Subject	fluorouracil	Small molecule	—	—

Indications

No indication recorded.