Status:
UNKNOWN
Organ Preservation in Elderly Patients With Rectal Cancer
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Conditions:
Rectal Cancer
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
In elderly patients postoperative mortality measured 3-6 months after total mesorectal excision is high. Thus, less toxic treatments may lead to a survival benefit for elderly patients even if a risk ...
Detailed Description
There are two steps of selection. In the first step, the elderly patients with small or moderately advanced tumours who should routinely receive neoadjuvant chemoradiation (or radiation alone in those...
Eligibility Criteria
Inclusion
- The initial eligibility criteria
- Age ≥70 years or \<70 years in patients with ASA 3+
- Tumour accessible by digital rectal examination
- Maximal tumour size (usually length) not more than 5 cm
- Circumferential bowel wall involvement not larger than 60%
- There will be two groups of patients:
- Candidates for preoperative (chemo)radiotherapy and local excision: tumour ≤3 cm, non-polipoid cT1, or cT2 or borderline cT3, cN0.
- Candidates for preoperative (chemo)radiotherapy and total mesorectal excision: cT2 tumors requiring abdominoperineal excision, or cT3 or resectable cT4 (slight involvement of vagina, prostate or seminal vesicles); cN+ is allowed.
- The final eligibility criterion
- • Complete clinical response obtained 8 weeks after chemoradiation or 10 weeks after short-course radiation
Exclusion
- Distant metastases
- Fixed tumour on digital rectal examination
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01863862
Start Date
August 1 2012
End Date
January 1 2020
Last Update
March 29 2019
Active Locations (1)
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1
M. Sklodowska-Curie Memorial Cancer Center
Warsaw, Poland, 02-781