NCT04009876

A Study to Evaluate a Chemotherapy Treatment Followed by Chemo and Radiotherapy in Patients With Rectal Cancer

Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy NALIRINOX (5-FU/LV + Oxaliplatin + Nal-IRI) Followed by Chemoradiotherapy in Patients With Rectal Cancer in a Watch-and-wait Program

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fundación de investigación HM · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory, open-label, single arm, non-randomized, multicenter, phase II clinical trial to determine the efficacy and clinical complete response rate in patients with rectal cancer and tumor preoperative evaluation after NAC (Neoadjuvant Chemotherapy) with NALIRINOX (5-FU \[fluorouracil)/LV \[Leucovorin calcium\] + oxaliplatin + nal-IRI \[Liposomal Irinotecan\]) and chemoradiotherapy.

Conditions

• Locally Advanced Rectal Cancer (LARC)

Interventions

Type	Name	Description
DRUG	nal-IRI	Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks)
PROCEDURE	Surgical resection	Surgical resection of the tumour
OTHER	Watch-and-wait	No surgery approach
DRUG	5-FU/LV	Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks)
DRUG	Oxaliplatin	Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks)

Timeline

• Start date: 2019-05-01
• Primary completion: 2022-10-21
• Completion: 2022-10-21
• First posted: 2019-07-05
• Last updated: 2022-12-13

Locations

4 sites across 1 country: Spain