Rectal cancer Rectal cancer
Conditions
Interventions
[Chemoradiotherapy]
45-50.4Gy in 25-28fractions to the whole pelvis using 3D comformal radiotherapy. Capecitaine according to the body surface area (refer to the following) twice daily during radiothe
Chemoradiotherapy, Brachytherapy
Sponsors
Yoshiomi Hatayama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed rectal adenocarcinoma. 2) Tumor lower margin is located at rectum (Ra, Rb, P). 3) High-resolution MRI scan is available and any of the following factors are present. cT=<3ab, cN0-1. 4) The diameter of the tumor bowel axis is 5cm or less, and the tumor circumference is 50% or less. 5) Eastern Cooperative Oncology Group performance status (PS) 0-1. 6) Age at enrollment must be 18 years or older. 7) Written informed concent.
Exclusion criteria
Exclusion criteria: 1) Endoscopic curative resection is possible (non-curative resection after endoscopic resection is not excluded). 2) Rectal stenosis (colonoscope cannot pass through). 3) Distant metastasis 4) Prior radiation therapy in the pelvic region. 5) Patients with myelosuppression (neutrophil count <1,500/mm3, platelet count <100,000/mm3). 6) Patients with severe renal impairment (Creatinine Clearance <30mL/min). 7) Active infection. 8) Pregnant women, lactating women, and men who may be or intend to become pregnant, or whose partners wish to become pregnant. 9) Other patients who are judged by the study physician to be inappropriate for the safe conduct of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Completion rate of preoperative treatment, early adverse event incidence rate, disease-free survival, distant metastasis-free survival, local recurrence-free survival, rectum-preserving survival, overall survival | — |
Contacts
Public ContactHatayama Yoshiomi
Hirosaki University Hospital
Outcome results
None listed