Clinical trial NCT01431599: Short-course Preoperative Chemoradiotherapy for Rectal Cancer
Official title: Two Week-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Rectal Cancer: Phase II Multicenter Clinical Trial (KROG 11-02)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: Locally advanced rectal cancer
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Samsung Medical Center
name: National Cancer Center, Korea
First posted: 2011-09-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: downstaging effect of tumor
timeFrame: an expected average of 6 weeks after chemoradiation
Secondary outcomes:
measure: bladder and small bowel toxicity after chemoradiation
timeFrame: Participants will be followed for an expected average of 3 months after chemoradiation
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center, Korea
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department fo Radiation Oncology, Seoul St. Mary's Hospital
name: Hong Seok Jang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swedish Rectal Cancer Trial; Cedermark B, Dahlberg M, Glimelius B, Pahlman L, Rutqvist LE, Wilking N. Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med. 1997 Apr 3;336(14):980-7. doi: 10.1056/NEJM199704033361402.
citation: Gerard A, Buyse M, Nordlinger B, Loygue J, Pene F, Kempf P, Bosset JF, Gignoux M, Arnaud JP, Desaive C, et al. Preoperative radiotherapy as adjuvant treatment in rectal cancer. Final results of a randomized study of the European Organization for Research and Treatment of Cancer (EORTC). Ann Surg. 1988 Nov;208(5):606-14. doi: 10.1097/00000658-198811000-00011.
citation: Lee JH, Kim JG, Oh ST, Lee MA, Chun HG, Kim DY, Kim TH, Kim SY, Baek JY, Park JW, Oh JH, Park HC, Choi DH, Park YS, Kim HC, Chie EK, Jang HS. Two-week course of preoperative chemoradiotherapy followed by delayed surgery for rectal cancer: a phase II multi-institutional clinical trial (KROG 11-02). Radiother Oncol. 2014 Jan;110(1):150-4. doi: 10.1016/j.radonc.2013.11.013. Epub 2014 Jan 7.