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Rectal CancerPhase 3CTS-179NCT00470951

Randomized Prospective Trial for Laparoscopic vs Open Resection for Rectal Cancer

A Phase 3 study testing open rectal resection and laparoscopic rectal resection in people with Rectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rectal Cancer
What is being tested?
open rectal resection and laparoscopic rectal resection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
1 siteSouth Korea
Study dates
Apr 2006to Aug 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Cr ≤ 1.5 mg/dl
  • Adequate cardiopulmonary function
  • Informed consent from patient or patient's relative

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • National Cancer Center, Korea

    Goyang-si, Gyeonggi-do, 410-769

Other trials in South Korea

About this study

Official title: A Comparison for Laparoscopically Assisted and Open Surgery for Advanced Rectal Cancer After Preoperative Chemoradiation- Randomized Prospective Trial

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.

Read the detailed description
  1. Title: A comparison for laparoscopically assisted and open surgery for advanced rectal cancer after preoperative chemoradiation - randomized prospective trial
  2. Principal investigator: Jae Hwan Oh Co-investigator: Seung Yong Jeong, Sung Bum Kang, Hyo Seong Choi, Seok-Byung Lim
  3. Purpose of the study: To compare efficacy of laparoscopic and open resection for locally advanced rectal cancer after preoperative chemoradiation
  4. Specific aims
  5. comparison of oncologic outcomes
  6. comparison of quality of life
  7. comparison of anorectal function
  8. Materials Rectal cancer <9cm from anal verge, measured by rigid sigmoidoscopy histologically proven adenocarcinoma locally advanced (T3), determined by CT, transrectal ultrasonography, MRI without any contraindication for general anesthesia,operation and chemoradiation Completion of preoperative chemoradiation
  9. Statistics
  10. Sample size calculation for non-inferiority trial: 340
  11. Disease free survival: Log-rank test,Cox regression analysis
  12. QOL and anorectal function: Repeated measured ANCOVA
  13. Methods
  14. operation time of operation : 6-8 weeks after end of preoperative chemoradiation surgical technique standard total mesorectal excision and high ligation of inferior mesenteric vessels
  15. preoperative chemoradiation chemotherapy: 2 cycles of 5-FU (400 mg/m2/day) + LV (20 mg/m2/day) IV bolus, for 3 days in 1st \& 5th wks of RT or Capecitabine 825 mg/m2 p.o. bid during RT RT:45 Gy/ 25 fractions to the pelvis, 5.4 Gy/ 3 fractions boost to the primary tumor over 5.5 wks
  16. postoperative chemotherapy 4 cycles of 5-FU (400 mg/m2/day) + LV (20 mg/m2/day) IV bolus, for 5 days, 4 wks interval
  17. oncologic outcomes
  18. Short-term outcomes Surgical length of incision op time blood loss intraoperative complications conversion rate Pathological resection margins (proximal, distal, circumferential) number of harvested lymph nodes length of resected bowel tumor regression grade (Dworak's grading) TNM staging Perioperative recovery duration of use of parenteral narcotics initiation of peristalsis initiation of oral intake duration of hospital stay 30-day postoperative mortality morbidity
  19. Long-term outcomes Primary end point Disease free survival (3 years after surgery) Secondary end points Overall survival Local recurrence Distant metastasis Port-site and wound site recurrence
  20. Quality of life Urinary function Duration of urinary catheterization Residual urine volume at discharge International Prostate Symptom Score (IPSS) Male sexual function International Index of Erectile Function (IIEF) Female sexual function Female Sexual Function Index (FSFI) QOL assessment EORTC QLQ C30 EORTC QLQ CR38
  21. Anorectal function Anorectal manometry Maximum Resting Pressure Maximum Squeezing Pressure High Pressure Zone Sphincter Length Sensory Threshold Rectal Capacity Rectal Compliance Rectoanal Inhibitory Reflex Fecal Incontinence Severity Index (FISI)
Conditions
Rectal Cancer
Being tested
open rectal resection, laparoscopic rectal resection
Keywords
rectal cancer, laparoscopic assisted resection, open resection, preoperative chemoradiation, randomized trial
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • open rectal resectionProcedure or surgery

    open rectal resection

  • laparoscopic rectal resectionProcedure or surgery

    laparoscopic assisted rectal resection

Study groups in NCT00470951
Study groupRoleWhat they receive
open rectal resectionActive comparatorconventional open resection
Receives: Procedure: open rectal resection
laparoscopic rectal resectionActive comparatorlaparoscopic rectal resection
Receives: Procedure: laparoscopic rectal resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease free survival

    Measured: 3 years

Secondary outcomes (3)

  1. Anorectal function

    Measured: 1 year

  2. Overall survival

    Measured: 3 year, 5 year

  3. Quality of life

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2007 (estimated)
  2. Study startApr 2006
  3. Primary completionAug 2012
  4. Study completionAug 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00470951
Sponsor's protocol ID
NCCCTS-06-179
Acronym
CTS-179
Status last verified
Aug 2012
First submitted
7 May 2007
Last updated
17 Aug 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33894918

  • 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.

    PubMed 30456502

  • 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.

    PubMed 24837215

  • 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.

    PubMed 20610322

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing open rectal resection and laparoscopic rectal resection in people with Rectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00470951, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2012.

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