NIPH Clinical Trials Search

Radical radiotherapy combining external beam radiotherapy and brachytherapy for rectal cancer

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Rectal cancer
Date of first enrollment	20/02/2026
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	[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 radiotherapy (Except for weekends). If the tumor is 3-5 cm long, this treatment will be performed first, and brachytherapy will be performed three weeks after completion. Single dose <1.31sqm, 900mg. 1.31sqm=< and 1.64sqm>, 1200mg. >1.64sqm, 1500mg. [Brachytherapy] Brachytherapy using an iridium-192 is administered at a dose of 6-10 Gy per fraction, once a week for a total of three fractions. If the tumor is 3cm or less in length, this treatment will be performed first, and chemoradiotherapy will be performed three weeks after completion. [Endoscopic Treatment] Endoscopic treatment is performed if residual or regrowing tumor in the mucosa or submucosa is found in 13 weeks after the end of radiotherapy. [Surgery] Surgery is performed as soon as possible if residual or regrowing tumor with more than muscle invasion is found in 3 or 13 weeks after the end of radiotherapy.

Outcome(s)

Primary Outcome	Clinical response rate
Secondary Outcome	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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.