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Total Neoadjuvant Treatment Without Surgery For Locally Advanced Rectal Cancer

NCT03565029 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-12-27

No results posted yet for this study

Summary

NO-CUT is a one-stage phase II trial seeking to establish whether an oxaliplatin-based chemotherapy preceding standard neo-adjuvant fluoropyrimidines-based chemo radiotherapy, can safely spare demolitive surgical intervention in patients with operable rectal cancer, without increasing the risk of distant relapse. The trial also has a translational component aimed at establishing whether selected genomic, epigenetic, and transcriptomic markers are predictive of tumor and patient outcome.

Conditions

  • Colo-rectal Cancer

Interventions

DRUG

XELOX

Capecitabine and Oxaliplatin (4x cycles)

RADIATION

Radiotherapy

Pelvic radiotherapy

Sponsors & Collaborators

  • Niguarda Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2022-10-31
Completion
2023-12-20

Countries

  • Italy

Study Locations

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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 NCT03565029 on ClinicalTrials.gov