Status:

UNKNOWN

Total Neoadjuvant Therapy in Rectal Cancer Treatment

Lead Sponsor:

State Scientific Centre of Coloproctology, Russian Federation

Conditions:

Rectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.

Detailed Description

In this randomized, controlled, parallel study we will comparison total neoadjuvant therapy with standard neoadjuvant therapy in rectal cancer treatment. Complete pathological response rate will be th...

Eligibility Criteria

Inclusion

  • Have signed an approved informed consent form for the stud;
  • Histologically confirmed rectal adenocarcinoma low (cT2-4N0-2M0) or mid rectum (сТ2-T4N1-2M0);

Exclusion

  • rectal cancer recurrence;
  • Primary-multiple tumours of other localizations;
  • pelvis radiotherapy in anamnesis;
  • pregnancy, breastfeeding;
  • distant metastasis;
  • ECOG score 3-4

Key Trial Info

Start Date :

October 30 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2023

Estimated Enrollment :

280 Patients enrolled

Trial Details

Trial ID

NCT04747951

Start Date

October 30 2020

End Date

November 1 2023

Last Update

February 15 2021

Active Locations (1)

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1

State Scientific Centre of Coloproctology

Moscow, Russia, 123453