rectal cancer
Conditions
Interventions
preoperative chemoradiotherapy+surgery
Sponsors
Department of Surgery Kindai University Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: # Pathologically proven adenocarcinoma. # Primary tumor located at Upper rectum, Lower rectum, and Anal canal. The lower border of the tumor located between the peritoneal reflection and the anal verge. # cT3 and cT4a tumor with a distance of less than 2 mm between tumor and mesorectal fascia on MRI # No Lateral lymph nodes (5mm and more in short axis diameter) on MRI data # No distant metastasis on contrast-enhanced CT or MRI (cM0) # Aged 20 to 75 years old # Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 # Adequate organ function as evidenced by the following laboratory studies and symptoms within 14 days prior to enrollment 1) White blood count >= 2,000 /mm3 2) Neutrophil count >= 1,000 /mm3 3) Platelet count >= 75,000 /mm3 4) Fever <= 38.0C 5) Diarrhea=< Grade 2 (CTCAE ver.4.0) 6) Stomatitis=< Grade 2 7) Total bilirubin=< Grade 2 8) AST /ALT =< Grade 2 9) Cr =< Grade 2 # Written informed consent
Exclusion criteria
Exclusion criteria: # Distant metastases # Cerebrovascular disease (CVD) with paralytic symptoms or prior CVD within one year. # Symptomatic or actively treated cardiac disorders. Or prior cardiac disorder within one year. # Cancerous fluid on diagnostic imaging. # Prior chemotherapy or pelvic irradiation for malignancy. # Other cancer diagnosis within the past 5 years (including colorectal cancer). # Interstitial pneumonia or fibroid lung. # Uncontrolled diabetes mellitus. # Uncontrolled hypertension # Ileus (cases with diverting stoma are eligible). # Uncontrolled diarrhea. # Pregnant, nursing or no intention to contraception. # Those considered inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, overall and disease-free survival, quality of life, adverse events, postoperative complications, pathological complete response rate, and diagnostic accuracy of MRI | — |
Countries
Japan
Contacts
Public ContactJunichiro Kawamura, MD
Kindai University Faculty of Medicine Surgery
Outcome results
None listed