Completed

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

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What is being tested

nal-IRI

+ Surgical resection

+ 5-FU/LV

DrugProcedureOther
Who is being recruted

Over 18 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2019
See protocol details

Summary

Principal SponsorFundación de investigación HM
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2019

Actual date on which the first participant was enrolled.

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.

Official TitlePhase 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
NCT04009876
Principal SponsorFundación de investigación HM
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

14 inclusion criteria required to participate
Male or females, aged ≥ 18 years.
Agree to participate and sign voluntary written ICF (Informed Consent Form) before any study specific procedure.
Patients with confirmed histopathological diagnosis of rectal cancer.
Patients with locally advanced rectal cancer T3-T4N0M0 or TxN+M0 and selected T2N0M0 candidates to watch & wait program.
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13 exclusion criteria prevent from participating
Patients with ECOG performance status ≥ 2.
Stage I (T1N0M0) or stage IV (TxNxM1) AJCC (American Joint Committee on Cancer) rectal cancer.
Any illness that the investigator considers will substantially increase the risk if the patient participates in the study.
Pregnant or breast-feeding woman.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks) and surgical resection

Group II

Experimental
Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks) and "watch-and-wait" surveillance protocol.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, SpainOpen Hospital Universitario Puerta de Hierro Majadahonda in Google Maps
Suspended

Hospital Universitario Madrid Sanchinarro

PAU de Sanchinarro, Spain
Suspended

Hospital General Universitario Gregorio Marañón

Madrid, Spain
Suspended

Hospital Universitario 12 de Octubre

Madrid, Spain
Completed4 Study Centers