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

NCT04009876 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-12-13

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Syntax for Science, S.L

    collaborator INDUSTRY

  • Fundación de investigación HM

    lead OTHER

Principal Investigators

  • Antonio Cubillo, MD · Director

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2022-10-21
Completion
2022-10-21

Countries

  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04009876 on ClinicalTrials.gov