NCT01431599

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

September 6, 2011

Last Update Submit

October 8, 2017

Conditions

Rectal Cancer

Keywords

Locally advanced rectal cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • bladder and small bowel toxicity after chemoradiation

    Participants will be followed for an expected average of 3 months after chemoradiation

Study Arms (1)

short-course

EXPERIMENTAL
Radiation: short-course radiation

Interventions

short-course radiationRADIATION

33Gy/10 fractions

short-course

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed adenocarcinoma
  • distal margin of the tumor located \< 8 cm above the anal verge
  • cT3-4 or cN+ classification as determined by endorectal ultrasonography (EUS) and CT
  • patient older than age 18 years
  • Karnofsky performance score \>= 70

You may not qualify if:

  • distant metastasis identified during staging workup
  • previous or concurrent malignancy
  • pregnant or breast-feeding women
  • impending rectal obstruction
  • familial adenomatous polyposis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Cancer Center, Korea

Goyang, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 9091798BACKGROUND

  • 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.

    PMID: 3056288BACKGROUND

  • 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.

    PMID: 24411228DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Hong Seok Jang, MD

    Department fo Radiation Oncology, Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong Hoon Lee, MD

CONTACT

82-010-8607-1269koppul@catholic.ac.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 6, 2011

First Posted

September 9, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2017

Last Updated

October 10, 2017

Record last verified: 2017-10

Locations

KR(3)