Status:
UNKNOWN
Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborating Sponsors:
Polish Society of Surgical Oncology
Conditions:
Rectal Neoplasms
Rectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Watch-and-wait strategy in rectal cancer is gaining momentum. There is a large variability in reporting the proportion of patients achieving clinical complete response (cCR) after routinely delivered ...
Eligibility Criteria
Inclusion
- Primary rectal cancer
- Low tumour (accessible by digital rectal examination)
- Routine preoperative radio(chemo)therapy according to the institutional policy; short-course radiation and immediate surgery is not allowed.
- Informed consent for watch-and-wait strategy or local excision in patients with cCR and near-cCR
Exclusion
- Recurrent cancer
- Cancers situated in the upper rectum
- Distant metastases
Key Trial Info
Start Date :
September 18 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT04095468
Start Date
September 18 2017
End Date
January 1 2026
Last Update
September 19 2019
Active Locations (7)
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1
Maria Skłodowska-Curie Institute - Oncology Center
Warsaw, Mazovian, Poland, 02-781
2
Collegium Medicum Nicolaus Copernicus University and Oncology Centre
Bydgoszcz, Poland
3
Regional Oncological Centre
Kielce, Poland
4
Jagiellonian Medical University College
Krakow, Poland