Lower rectal cancer
Conditions
Interventions
None listed
Sponsors
National cancer center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age at registration is 75 and over. 2) Primary tumor located at lower rectum, and the lower border of the primary tumor located at anal side of middle Houston valve by endoscopic finding before local resection. 3) Within 16 weeks after local resection. 4) Complete resection (en bloc) was performed by local resection and pathologically diagnosed as HM0 and VM0 (= PM0, DM0, RM0) 5) Pathological T1 cancer with fulfilled either of the following condition. i) Poorly differentiated adenocarcinoma (por), or mucinous adenocarcinoma (muc), or signet-ring cell carciona (sig), ii) Pathological T1b, iii) Lymphatic invasion positive or venous invasion positive, iv) Budding grade of 2-3 or pathological T2 cancer with fulfilled both of the following condition. i) well or moderately diiferentiated adenocarcinoma, ii) the greatest tumor diameter was within 3 cm. 6) Neither lymph node metastases nor distant metastases was confirmed by chest, abdomen, and pelvis computed tomography (cN0M0) 7) Witten informed consent is obtained 8) Patients who are 75 years or older who are planned radical surgery without local excision and who meet the above 2) by endoscopic diagnosis before surgery and 5) by the postoperative pathology enables registration to group A.
Exclusion criteria
Exclusion criteria: 1) Patients thought to be ineligible for this study by their doctor. 2) Without written informed consent from patient or his/her family. 3) Of patients in group A registered according to eligibility criteria 8), if post-operative pathological findings prove that they do not meet eligibility criteria 5), they are excluded at that point and excluded from the final analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year non-deteriorating rate of quality of life (Wexner score, Low anterior resection syndrome (LARS) score, Proportion of anus-preservation without stoma at 2 year) | — |
Secondary
| Measure | Time frame |
|---|---|
| Deteriorating rate of the degree of living independence for the elderly patients with/without dementia(2-year), scoring of Mini-cog scale(2 year), complication of the treatment (2 year), overall survival (5 year), relapse free survival (5 year), rate of occuring other disieases (5 year) | — |
Countries
Japan
Contacts
Public ContactTakeshi Sasaki
National cancer center Hospital East division of Colorectal Surgery
Outcome results
None listed