advanced lower rectal cancer
Conditions
Interventions
laparoscopic lateral pelvic lymph node dissection
lateral lymph node dissection by open surgery
Sponsors
Chubu Clinical Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically confirmed adenocarcinoma (2)recquirement to all of follows by preoperative diagnostic imaging 1.invasion depth is more than T3, or metastasis in N1, N2 lymph node 2.Main lesion of the tumor is located at the rectum 3.Lower tumor margin is below the peritoneal reflection 4.No extramesorectal lymph node swelling (Shorter diameter is less than 10 mm) 5.No invasion to other organ (s) (3) no past history of pelvic radiation (4)without multiple malignancies (5)Patient age is more than 20 and less than 75 (6)PS: 0, 1 (7)adequate organ function (8) Written informed consent
Exclusion criteria
Exclusion criteria: 1.Multiple malignancies to be treated 2.Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. 3.Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer 4.Uncontrolled severe complications(DM, hypertension, diarrhea, et al.) 5.Massive pleural effusion or ascites that required drainage. 6.Patient with symptomatic cardiovascular disease or asymptomatic disease but has been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. 7.With interstitial lung disease or pulmonary fibrosis 8.Continuous systemic steroid therapy (oral or intravenous administration) 9.A history and/or current evidence of significant neurological and/or mental illness 10.Not appropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of complication | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year local recurrence-free survival,3-year recurrece-free survival,recurrence-free survival,overall survival,operative time,intraoperative bleeding,transition to open surgery,completion of surgery, number of dissected lateral lymph node, voiding dysfunction, hospital days after surgery | — |
Countries
Japan
Contacts
Public ContactTetsuya Wada
M's system data center
Outcome results
None listed