Efficacy and Safety of SCRT Versus TNT in Older Patients With Locally Advanced Rectal Cancer — SHAPERS  

Locally Advanced Rectal Cancer Clinical Trial

Official title: Efficacy and Safety of Short-course Radiotherapy (SCRT) Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer: a Multicentre, Open-label, Randomised Pragmatic Clinical Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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.

Subjects meeting all eligibility criteria will be randomised in a 1:1 ratio to either the SCRT arm or the TNT arm (The study design is shown in figure 3.1 and 3.2).

SCRT arm:

The SCRT arm consists of:

• SCRT (5 fractions of 5 Gy), followed by

• Surgery (according to the principles of TME) or watch & wait, followed by

• Optional adjuvant chemotherapy

TNT arm Different treatment regimens can be used in the TNT arm including Rapido, Rapido light, OPRA INCT-CRT or OPRA CRT-CNCT. The regimen to use will be decided by the investigator and will need to be declared before randomisation. No switch between regimens is allowed during the study treatment period.

The Rapido regimen consists of:

• SCRT (5 fractions of 5 Gy), followed by

• Up to 18 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX), followed by

• Surgery (according to the principle of TME) or "watch & wait".

The Rapido light regimen consists of:

• SCRT (5 fractions of 5 Gy), followed by

• Up to 12 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX), followed by

• Surgery (according to the principle of TME) or "watch & wait".

The OPRA with induction chemotherapy (INCT-CRT) regimen, consists of:

• Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX), followed by

• CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) followed by

• Surgery (according to the principle of TME) or "watch & wait"

The OPRA with consolidation chemotherapy (CRT-CNCT) regimen consists of:

• CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) followed by

• Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX), followed by

• Surgery (according to the principle of TME) or "watch & wait". ;

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Older People
• Rectal Neoplasms

• NCT number: NCT06052332
• Study type: Interventional
• Source: Jules Bordet Institute
• Contact: Tabatha Delsaute
• Phone: +32 (0)2 541 36 62
• Email: ctsu.shapers@hubruxelles.be
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2024
• Completion date: December 2033