Trial Information
Two Week-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Rectal Cancer: Phase II Multicenter Clinical Trial (KROG 11-02)
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
downstaging effect of tumor
Outcome Description:
Comparison of clinical T staging and pathologic T staging example> cT4 --> pT1 after chemoradiation: down staging (+)
Outcome Time Frame:
an expected average of 6 weeks after chemoradiation
Safety Issue:
No
Principal Investigator
Hong Seok Jang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department fo Radiation Oncology, Seoul St. Mary's Hospital
Authority:
Korea: Ministry for Health, Welfare and Family Affairs
Study ID:
KROG 11-02
NCT ID:
NCT01431599
Start Date:
September 2011
Completion Date:
October 2017
Related Keywords:
- Rectal Cancer
- Locally advanced rectal cancer
- Rectal Neoplasms