Organ Preservation in Elderly Patients With Rectal Cancer: a Prospective Observational Study
70 Years
N/A
Both
Rectal Cancer
Trial Information
Organ Preservation in Elderly Patients With Rectal Cancer: a Prospective Observational Study
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 unfit for chemotherapy) prior to full-thickness local excision
using transanal endoscopic microsurgery or prior to total mesorectal excision will be
included. In the next step, only patients with clinical complete response obtained 8-10
weeks from completion of (chemo)radiation are selected. Those patients constitute study
group and will be observed without further treatment. The remaining patients with residual
cancer will proceed to routine management, namely transanal endoscopic microsurgery or total
mesorectal excision. Patients undergoing transanal endoscopic microsurgery and having poor
response to (chemo)radiation (ypT2-3 disease or positive margin) will proceed to the
conversion to total mesorectal excision.
Neoadjuvant chemoradiation: 50 Gy total dose over 5 weeks with 2 Gy per fraction delivered
with simultaneous chemotherapy consisting of three cycles of 5-Fu 200 mg/m2 i.v. bolus and
leucovorin 100 mg/m2 i.v. short infusion over 2 days given during 1-2, 15-16, and 29-30 days
of radiotherapy. Patients unfit for chemotherapy will receive 25 Gy total dose over 5 days
with 5 Gy per fraction.
The study hypothesis is that in clinical complete responders after (chemo)radiation treated
without initial surgery, the local recurrence rate will be less than 25% and results of the
rescue surgery (local and distant recurrence rate) will be not worse (or only slightly
worse) than that seen after up-front total mesorectal excision in patients with similar
stage of the disease.
Inclusion Criteria:
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:
1. Candidates for preoperative (chemo)radiotherapy and local excision: tumour ≤3 cm,
non-polipoid cT1, or cT2 or borderline cT3, cN0.
2. 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 Criteria:
- Distant metastases
- Fixed tumour on digital rectal examination
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The final three-year rate of local and distant recurrences taking into consideration results of rescue surgery for pelvic recurrence.
Outcome Time Frame:
After 3 years of median follow-up for living patients.
Safety Issue:
No
Principal Investigator
Krzysztof Bujko, Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
M. Sklodowska-Curie memorial Cancer Centre in Warsaw
Authority:
Poland: Ethics Committee
Study ID:
PGBRJG0113
NCT ID:
NCT01863862
Start Date:
August 2012
Completion Date:
January 2016
Related Keywords:
- Rectal Cancer
- Rectal cancer
- Chemoradiation
- Complete pathological response
- Rectal Neoplasms
Name | Location |
|---|
