Rectal NeoplasmPhase 2NCT01591798
Efficacy Study of Robotic Surgery for Rectal Cancer
A Phase 2 study testing Robotic surgery and Laparoscopic surgery in people with Rectal Neoplasm, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
After introducing minimally invasive surgery, robotic surgery has been increasingly used in colorectal cancer. However, there is a few prospective study for robotic surgery. The aim of this trial is to evaluate the effectiveness and safety of robotic surgery in mid or low rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Neoplasm
- What is being tested?
- Robotic surgery and Laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Dec 2017
- Phase
- Phase 2
- 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 or low rectal cancer (within 9cm from anal verge)
- pathologically proven as adenocarcinoma
- written informed consent
- no severe functional disability in lung and heart
Who cannot join
- invading adjacent organ
- distant metastasis (lung, liver, brain, bone, distant lymph nodes etc.)
- lateral pelvic lymph node metastasis
- Have severe concomitant disease that might limit compliance or completion of the protocol.
- Have any other malignancy that might impact 5-year survival or might be potentially confused with rectal cancer.
- If female, be pregnant or breast feeding.
- Hereditary colorectal cancer (HNPCC, FAP etc)
- emergency operation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Jae Hwan Oh, Dr., 82-31-920-1637, jayoh@ncc.re.kr
About this study
Official title: Clinical Assessment of Laparoscopic and Robotic Surgery for Rectal Cancer - Randomized Phase II Trial
After introducing minimally invasive surgery, robotic surgery has been increasingly used in colorectal cancer. However, there is a few prospective study for robotic surgery. The aim of this trial is to evaluate the effectiveness and safety of robotic surgery in mid or low rectal cancer.
Read the detailed description
This study was designed as randomized phase II trial (laparoscopic versus robotic). The primary end point is quality of mesorectal excision.
- Conditions
- Rectal Neoplasm
- Being tested
- Robotic surgery, Laparoscopic surgery
- Keywords
- Rectal cancer, Robotic surgery, Laparoscopic surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic surgeryProcedure or surgery
Also called da Vinci Surgical System
Robotic assisted rectal resection
Laparoscopic surgeryProcedure or surgery
Laparoscopic assisted rectal resection
| Study group | Role | What they receive |
|---|---|---|
| Robotic surgery | Experimental | Proctectomy using robot Receives: Procedure: Robotic surgery |
| Laparoscopic surgery | Active comparator | Conventional laparoscopic rectal resection Receives: Procedure: Laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of mesorectal excision
Evaluating the quality of mesorectal excision in rectal specimen according to the criteria suggested by Nagtegaal ID, et al. (J Clin Oncol. 2002;20:1729-34)
Measured: 7days after surgery (Pathologic report)
Secondary outcomes (3)
Short-term postoperative outcome
Measured: Within postoperative 30 days
Sexual and urinary function, Quality of life, Anorectal function
IIEF, FSFI, IPSS, EORTC C30, CR38, FISI, MSKCC bowel fuction tool, Manometry
Measured: Baseline, postop 3 weeks, 3months, 12 months, 24 months, 36 months
Long-term outcome
3 year disese-free survival
Measured: Postoperative 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ji Won Park, National Cancer Center, Korea
- Investigators
- Ji Won Park, Dr., Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591798
- Sponsor's protocol ID
- NCC-CTS603
- Status last verified
- May 2012
- First submitted
- 16 Mar 2012
- Last updated
- 7 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Laparoscopic and Robotic Surgery for Rectal Cancer - Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT01591798
- Acronym / sponsor ID
- NCC-CTS603
- Conditions
- Rectal Neoplasm
- Keywords
- Rectal cancer, Robotic surgery, Laparoscopic surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Mar 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After introducing minimally invasive surgery, robotic surgery has been increasingly used in colorectal cancer. However, there is a few prospective study for robotic surgery. The aim of this trial is to evaluate the effectiveness and safety of robotic surgery in mid or low rectal cancer.
Detailed description
This study was designed as randomized phase II trial (laparoscopic versus robotic). The primary end point is quality of mesorectal excision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic surgery | Experimental | Procedure: Robotic surgeryProctectomy using robot |
| Laparoscopic surgery | Active comparator | Procedure: Laparoscopic surgeryConventional laparoscopic rectal resection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- mid or low rectal cancer (within 9cm from anal verge)
- pathologically proven as adenocarcinoma
- written informed consent
- no severe functional disability in lung and heart
Key exclusion criteria (8 listed)
- invading adjacent organ
- distant metastasis (lung, liver, brain, bone, distant lymph nodes etc.)
- lateral pelvic lymph node metastasis
- Have severe concomitant disease that might limit compliance or completion of the protocol.
- Have any other malignancy that might impact 5-year survival or might be potentially confused with rectal cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic surgeryAlso: da Vinci Surgical SystemRobotic assisted rectal resection | Procedure or surgery | Robotic surgery |
| Laparoscopic surgeryLaparoscopic assisted rectal resection | Procedure or surgery | Laparoscopic surgery |
Primary outcome
Quality of mesorectal excision
Time frame: 7days after surgery (Pathologic report)
Evaluating the quality of mesorectal excision in rectal specimen according to the criteria suggested by Nagtegaal ID, et al. (J Clin Oncol. 2002;20:1729-34)
3 secondary outcomes
Short-term postoperative outcome
Time frame: Within postoperative 30 days
Sexual and urinary function, Quality of life, Anorectal function
Time frame: Baseline, postop 3 weeks, 3months, 12 months, 24 months, 36 months
Long-term outcome
Time frame: Postoperative 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Won Park, Dr. principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Robotic surgery and Laparoscopic surgery in people with Rectal Neoplasm, 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 4 inclusion and 8 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 7 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Jae Hwan Oh, Dr. (82-31-920-1637, jayoh@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of mesorectal excision (time frame: 7days after surgery (Pathologic report)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2012.