Clinical trial · Interventional
Randomized Prospective Trial for Laparoscopic vs Open Resection for Rectal Cancer
A Comparison for Laparoscopically Assisted and Open Surgery for Advanced Rectal Cancer After Preoperative Chemoradiation- Randomized Prospective Trial
NCT00470951CI-TRIAL-00007839CTS-179unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laparoscopic rectal resection | Procedure | — | UNRESOLVED |
| open rectal resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- open rectal resection
- description
- conventional open resection
- interventionNames
- Procedure: open rectal resection
- type
- ACTIVE_COMPARATOR
- label
- laparoscopic rectal resection
- description
- laparoscopic rectal resection
- interventionNames
- Procedure: laparoscopic rectal resection
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 3 years
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (4)
- DERIVEDPark 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 33894918
- DERIVEDPark 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 30456502
- DERIVEDJeong 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 24837215
- DERIVEDKang 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 20610322