NCT05054959

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

Induction Versus Consolidation Chemotherapy in Total Neoadjuvant Therapy of Localy Advanced Rectal Cancer With High Risk of Recurrence (ICONA Study)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to identify the most promising sequence of modalities in total neoadjuvant treatment of localy advanced rectal cancer with high risk of recurrence

Detailed description

International recommendations for the treatment of LARC with a high risk of disease recurrence are inconsistent, regarding TNT. In Germain randomised study more pCR were achieved with consolidation chemotherapy. We will compare our standard approach (induction plus consolidation CT) with consolidation CT.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
OTHER	consolidation chemotherapy	6 cycles CAPOX after chemoradiotherapy
OTHER	induction chemotherapy	4 cycles CAPOX before and 2 cycles CAPOX after chemoradiotherapy

Timeline

• Start date: 2021-06-24
• Primary completion: 2022-12-31
• Completion: 2027-12-31
• First posted: 2021-09-23
• Last updated: 2021-09-23

Locations

1 site across 1 country: Slovenia