Status:

UNKNOWN

IMMUNOlogical Microenvironment in REctal Adenocarcinoma Treatment.

Lead Sponsor:

University of Padova

Collaborating Sponsors:

Associazione Italiana per la Ricerca sul Cancro

Azienda Ospedaliera di Padova

Conditions:

Rectal Cancer

Eligibility:

All Genders

18+ years

Brief Summary

Background The current management on rectal cancer based on TNM staging has some limitations. In locally advanced rectal cancer after neoadjuvant therapy the persistence of a complete response to ther...

Detailed Description

Locally advanced rectal cancer: which treatment after complete response after neoadjuvant therapy? Combined treatment for locally advanced rectal cancer achieves a 5-year overall survival close to90% ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • locally advanced (cT3-4 and/or N+, TNM stage II-III) low and medium rectal cancer (\<11 cm) or low rectum adenocarcinoma cT≤2, at risk for abdominoperineal amputation, undergoing neoadjuvant therapy will be included in the study group.
  • Only neoadjuvant therapy protocols including long course radiotherapy (45 Gy) and fluoropyrimidine-based regimens will be included while short radiation therapy of radiation therapy or chemotherapy alone will be excluded
  • at least 6 weeks after the end of the neoadjuvant therapy will be included
  • Full availability of clinical records at least 1 year of follow up

Exclusion

    Key Trial Info

    Start Date :

    January 1 2020

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 31 2024

    Estimated Enrollment :

    544 Patients enrolled

    Trial Details

    Trial ID

    NCT04917263

    Start Date

    January 1 2020

    End Date

    December 31 2024

    Last Update

    June 8 2021

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Azienda Ospedale Università di Padova

    Padua, Italy, 35128