Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

Thank you

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

Name

Location