NCT00470951

Brief Summary

The investigators designed the randomized prospective trial of comparing open and laparoscopic resection in locally advanced rectal cancer after preoperative chemoradiation in order to determine the oncologic and functional efficacy of laparoscopic rectal resection.

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
340

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

April 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2007

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 17, 2012

Status Verified

August 1, 2012

Enrollment Period

6.3 years

First QC Date

May 7, 2007

Last Update Submit

August 16, 2012

Conditions

Rectal Cancer

Keywords

rectal cancerlaparoscopic assisted resectionopen resectionpreoperative chemoradiationrandomized trial

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    3 years

Secondary Outcomes (3)

  • Anorectal function

    1 year

  • Overall survival

    3 year, 5 year

  • Quality of life

    preop, postop 3mo, posop 1 yr, 3yr, 5yr

Other Outcomes (1)

  • Immunologic response

    preop, postop 2hr, postop 1day, 5day

Study Arms (2)

open rectal resection

ACTIVE COMPARATOR

conventional open resection

Procedure: open rectal resection

laparoscopic rectal resection

ACTIVE COMPARATOR

laparoscopic rectal resection

Procedure: laparoscopic rectal resection

Interventions

open rectal resectionPROCEDURE

open rectal resection

open rectal resection
laparoscopic rectal resectionPROCEDURE

laparoscopic assisted rectal resection

laparoscopic rectal resection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mid to low rectal cancer (within 9cm from AV, measured by RS)
  • Histologically proven adenocarcinoma
  • Locally advanced (T3, determined by CT, MRI and TRUS)
  • Completion of preoperative chemoradiation
  • Age: 18-80
  • Hb ≥ 10g/dl, WBC≥ 3,000/mm3, Plt≥ 100,000/mm3
  • Cr ≤ 1.5 mg/dl
  • Adequate cardiopulmonary function
  • Informed consent from patient or patient's relative

You may not qualify if:

  • Metastasis in liver, lung, brain, bone, paraaortic LN, subclavicular LN, inguinal LN
  • Second primary malignancy (except CIS of the cervix or adequately treated skin cancer or prior malignancy treated more than 5 years ago without recurrence)
  • Cardiopulmonary dysfunction
  • Active, uncontrolled infection
  • Active, uncontrolled psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Related Publications (4)

  • Park JW, Kang SB, Hao J, Lim SB, Choi HS, Kim DW, Chang HJ, Kim DY, Jung KH, Kim TY, Kang GH, Chie EK, Kim SY, Sohn DK, Kim JS, Lee HS, Kim JH, Jeong SY, Oh JH. Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): 10-year follow-up of an open-label, non-inferiority, randomised controlled trial. Lancet Gastroenterol Hepatol. 2021 Jul;6(7):569-577. doi: 10.1016/S2468-1253(21)00094-7. Epub 2021 Apr 23.

    PMID: 33894918DERIVED

  • Park JS, Kang H, Park SY, Kim HJ, Woo IT, Park IK, Choi GS. Long-term oncologic after robotic versus laparoscopic right colectomy: a prospective randomized study. Surg Endosc. 2019 Sep;33(9):2975-2981. doi: 10.1007/s00464-018-6563-8. Epub 2018 Nov 19.

    PMID: 30456502DERIVED

  • Jeong SY, Park JW, Nam BH, Kim S, Kang SB, Lim SB, Choi HS, Kim DW, Chang HJ, Kim DY, Jung KH, Kim TY, Kang GH, Chie EK, Kim SY, Sohn DK, Kim DH, Kim JS, Lee HS, Kim JH, Oh JH. Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-label, non-inferiority, randomised controlled trial. Lancet Oncol. 2014 Jun;15(7):767-74. doi: 10.1016/S1470-2045(14)70205-0. Epub 2014 May 15.

    PMID: 24837215DERIVED

  • Kang SB, Park JW, Jeong SY, Nam BH, Choi HS, Kim DW, Lim SB, Lee TG, Kim DY, Kim JS, Chang HJ, Lee HS, Kim SY, Jung KH, Hong YS, Kim JH, Sohn DK, Kim DH, Oh JH. Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): short-term outcomes of an open-label randomised controlled trial. Lancet Oncol. 2010 Jul;11(7):637-45. doi: 10.1016/S1470-2045(10)70131-5. Epub 2010 Jun 16.

    PMID: 20610322DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jae Hwan Oh, M.D., ph.D.

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 7, 2007

First Posted

May 8, 2007

Study Start

April 1, 2006

Primary Completion

August 1, 2012

Study Completion

August 1, 2014

Last Updated

August 17, 2012

Record last verified: 2012-08

Locations

KR(1)