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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1
Hospital Clínic de Barcelona
Barcelona, Spain, 08036