Resectable local pelvic recurrence of rectal cancer
Conditions
Interventions
Neoadjuvant chemoradiothearpy with capecitabine followed by laparoscopic surgery Capecitabine
treatment dose was decided by body mass index
Sponsors
Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1: R0 resection was performed by the initial surgery for rectal malignant tumor 2: The diagnosis of recurrent rectal cancer was proven with tissue biopsy, or with medical imaging. 3: The recurrent tumor should be localized without extra-pelvic metastasis, distant metastasis was absent. 4: Patients had to have ECOG performance status of 0 or 1. 5: Written informed consent was obtained from all patients before enrollment.
Exclusion criteria
Exclusion criteria: 1: Unresectable: tumor extension into S1 nerve, external iliac artery,obturator internus muscle 2: Patients with serious complications 3: Patients who would not complete this study according to surgeon's decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (operative time, intraoperative bleeding, conversion to open surgery, incidence of complication after surgery, hospitalized days after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate TRG: tumor regression grade pCRM: pathological circumferential resection margin QOL: quality of life after surgery OS: overall survival RFS: recurrence free survival LFS: local recurrence free survival, | — |
Countries
Japan
Contacts
Public ContactKimura Kei
Hyogo College of Medicine Division of Lower GI Surgery, Department of Surgery
Outcome results
None listed