Short-course Preoperative Chemoradiotherapy for Rectal Cancer

Rectal Cancer Clinical Trial

— KROG 11-02  

Official title:

Two Week-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Rectal Cancer: Phase II Multicenter Clinical Trial (KROG 11-02)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01431599
• Other study ID #: KROG 11-02
• Status: Recruiting
• Phase: Phase 2
• First received: September 6, 2011
• Last updated: October 8, 2017
• Start date: September 2011
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: Seoul St. Mary's Hospital
• Contact: Jong Hoon Lee, MD
• Phone: 82-010-8607-1269
• Email: koppul[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2017
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• short-course radiation
33Gy/10 fractions

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Jong Hoon Lee	National Cancer Center, Korea, Samsung Medical Center, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Gérard A, Buyse M, Nordlinger B, Loygue J, Pène 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. — View Citation

Swedish Rectal Cancer Trial, Cedermark B, Dahlberg M, Glimelius B, Påhlman 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. Erratum in: N Engl J Med 1997 May 22;336(21):1539. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	downstaging effect of tumor	Comparison of clinical T staging and pathologic T staging example> cT4 --> pT1 after chemoradiation: down staging (+)	an expected average of 6 weeks after chemoradiation
Secondary	bladder and small bowel toxicity 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)	Participants will be followed for an expected average of 3 months after chemoradiation