Status:
UNKNOWN
Planned Non-operative Management for Rectal Cancer
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Conditions:
Rectal Cancer
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The investigators propose to conduct an observational study on consecutive patients with low-lying or mid rectal cancers smaller than 5 cm in length and less than 50% of rectal circumferential extent....
Eligibility Criteria
Inclusion
- Adenocarcinoma of the rectum classified clinically as T2, T3a-c or T4b but only with superficial infiltration of the vagina or prostate; tumour accessible by digital rectal examination; tumour ≤5 cm in length and ≤50% of rectal circumferential extent; N0-N2, but mesorectal node \<7 mm and no lateral nodes enlargement); extramural vascular invasion but not larger than 7 mm in the largest dimension; M0.
- Operable patient
- Patient having read the information note and having signed the informed consent
- Follow-up possible
Exclusion
- Inoperable patient
- cT1, cT3d, large T4, tumour ≥5cm or ≥50 of rectal circumferential extent
- Enlargement of lateral nodes or any node ≥8 mm in diameter
- Patient presenting metastasis at diagnosis
- Previous pelvic irradiation
- Simultaneous progressive another cancer
- Close follow-up uncertain.
Key Trial Info
Start Date :
August 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05241574
Start Date
August 3 2021
End Date
October 1 2023
Last Update
February 15 2022
Active Locations (1)
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1
M. Skłodowska-Curie National Research Institute of Oncology
Warsaw, Poland, 02-781