Status:

UNKNOWN

Interval Between Neoadjuvant Therapy and Surgery in the Treatment of Locally Advanced Rectal Cancer (CRONOS)

Lead Sponsor:

Hospital Clinic of Barcelona

Collaborating Sponsors:

Complejo Hospitalario Universitario de Santiago

Hospital Universitario Marqués de Valdecilla

Conditions:

Rectal Cancer

Neoadjuvant Therapy

Eligibility:

All Genders

Brief Summary

The investigators evaluate the response of rectal cancer to neoadjuvant therapy and classify the response according to specific periods of time after the end of neoadjuvant treatment.

Detailed Description

In the treatment of locally advanced rectal cancer, an optimal interval between neoadjuvant therapy and surgery might improve oncological outcomes. Besides, those patients who achieve a good response ...

Eligibility Criteria

Inclusion

  • Adult patients suitable for elective surgical resection of biopsy-confirmed rectal adenocarcinoma (0-15 cm from the anal verge) determined by rectal cancer protocol magnetic resonance imaging.
  • Patients treated with long-course neoadjuvant chemoradiotherapy (nCRT).
  • Patients treated with short-course radiotherapy with delayed surgery.
  • Clinical stage IIA, IIB, IIIA, IIIB, IIIC (cT3/cT4, or cN1/cN2 with any cT, M0) determined by rectal cancer protocol magnetic resonance imaging

Exclusion

  • Intolerance or contraindication to planned NAT.
  • Patients who have not finished NAT for any reason.
  • Patients with unknown cT or cM.
  • Tumors previously treated with local excision or with distant metastatic disease.

Key Trial Info

Start Date :

February 25 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 25 2021

Estimated Enrollment :

911 Patients enrolled

Trial Details

Trial ID

NCT04717947

Start Date

February 25 2020

End Date

June 25 2021

Last Update

February 4 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hospital Clínic de Barcelona

Barcelona, Spain, 08036