Rectal Cancer
Conditions
Keywords
Locally advanced rectal cancer
Brief summary
The purpose of this study is to evaluate the early clinical outcome of the short-course preoperative chemoradiotherapy, 33Gy/10 fx and delayed operation after chemoradiation, the investigators initiated the clinical trial of KROG 11-02.
Interventions
RADIATIONshort-course radiation
33Gy/10 fractions
Sponsors
Seoul National University Hospital
Samsung Medical Center
National Cancer Center, Korea
Jong Hoon Lee
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. histologically confirmed adenocarcinoma 2. distal margin of the tumor located \< 8 cm above the anal verge 3. cT3-4 or cN+ classification as determined by endorectal ultrasonography (EUS) and CT 4. patient older than age 18 years 5. Karnofsky performance score \>= 70
Exclusion criteria
1. distant metastasis identified during staging workup 2. previous or concurrent malignancy 3. pregnant or breast-feeding women 4. impending rectal obstruction 5. familial adenomatous polyposis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| downstaging effect of tumor | an expected average of 6 weeks after chemoradiation | Comparison of clinical T staging and pathologic T staging example\> cT4 --\> pT1 after chemoradiation: down staging (+) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bladder and small bowel toxicity after chemoradiation | Participants will be followed for an expected average of 3 months after chemoradiation | The incidence of grade 3 or higher small bowel and bladder toxicity according to the RTOG and EORTC toxicity criteria (reference: Cox JD et al. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6) |
Countries
South Korea
Contacts
Primary ContactJong Hoon Lee, MD
Outcome results
None listed