Short-course Preoperative Chemoradiotherapy for Rectal Cancer

Phase 2

• Conditions: Rectal Cancer
• Interventions: Radiation: short-course radiation

• Registration Number: NCT01431599
• Lead Sponsor: Jong Hoon Lee

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-06
• Study First Submitted QC: 2011-09-07
• Study First Posted: 2011-09-09
• Primary Completion: 2012-10
• Status Verified: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-08
• Last Update Posted: 2017-10-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
short-course	short-course radiation	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (3)

National Cancer Center, Korea; 🇰🇷 Goyang, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of