Short-course Preoperative Chemoradiotherapy for Rectal Cancer (KROG 11-02)

Jong Hoon Lee

Status and phase: Unknown; Phase 2

Conditions: Rectal Cancer

Treatments: Radiation: short-course radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01431599

KROG 11-02

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

short-course

Experimental group

Treatment:

Radiation: short-course radiation