Recurrent Rectal CancerNCT01196000
Laparoscopic Surgery or Robotic-Assisted Laparoscopic Surgery in Treating Patients With Rectal Cancer That Can Be Removed By Surgery
A study testing conventional laparoscopic surgery, robotic-assisted laparoscopic surgery and quality-of-life assessment in people with Recurrent Rectal Cancer and Stage I Rectal Cancer, run by City of Hope Medical Center.
Trial summary
RATIONALE: Robotic-assisted laparoscopic surgery may be a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether robotic-assisted laparoscopic surgery is more effective than laparoscopic surgery in treating patients with rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Rectal Cancer, Stage I Rectal Cancer, Stage II Rectal Cancer
- What is being tested?
- conventional laparoscopic surgery, robotic-assisted laparoscopic surgery and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Jul 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent
- Diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection (i.e. staged T1-3, N0-2, M0 by CT and MRI or transrectal ultrasound)
- Rectal cancer suitable for resection by either standard or robotic-assisted laparoscopic procedure
- Fit for robotic-assisted or standard laparoscopic rectal resection
- ASA =< 3
- Capable of completing required questionnaires at time of consent
Who cannot join
- Benign lesions of the rectum
- Cancers of the anal canal
- Locally advanced cancers not amenable to curative surgery
- Locally advanced cancers requiring en bloc multi-visceral resection
- Synchronous colorectal tumours requiring multi-segment surgical resection
- Co-existent inflammatory bowel disease
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- Clinical or radiological evidence of metastatic spread
- Concurrent or previous diagnosis of invasive cancer within 5 years that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer treated with curative intent are acceptable; for other cases please discuss with Chief Investigator via CTRU)
- History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
- Pregnancy
- Participation in another rectal cancer clinical trial relating to surgical technique
About this study
Official title: Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer
RATIONALE: Robotic-assisted laparoscopic surgery may be a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether robotic-assisted laparoscopic surgery is more effective than laparoscopic surgery in treating patients with rectal cancer.
PURPOSE: This randomized clinical trial studies robotic-assisted laparoscopic surgery to see how well it works compared to laparoscopic surgery in treating patients with rectal cancer that can be removed by surgery.
Read the detailed description
OBJECTIVES:
- To evaluate robotic-assisted rectal cancer surgery versus standard laparoscopic rectal cancer resection by means of a randomized, controlled trial.
II. To assess technical ease of the operation, as determined by the clinical indicator of low conversion rate to open operation.
III. To assess surgical accuracy and improved oncological outcome as determined by clear pathological resection margins.
IV. To assess quality of life and analyze cost-effectiveness to aid evidence-based knowledge to inform NHS and other service providers and decision-makers.
- To analyze disease-free and overall survival and local recurrence rates at 3-year follow-up.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo standard laparoscopic resection.
ARM II: Patients undergo robotic-assisted laparoscopic resection.
After completion of study treatment, patients are followed up at 1 month, 6 months, and then annually thereafter for 3 years.
- Conditions
- Recurrent Rectal Cancer, Stage I Rectal Cancer, Stage II Rectal Cancer, Stage III Rectal Cancer
- Being tested
- conventional laparoscopic surgery, robotic-assisted laparoscopic surgery, quality-of-life assessment, questionnaire administration
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional laparoscopic surgeryProcedure or surgery
Also called laparoscopy-assisted surgery, surgery, laparoscopic
operation using conventional laparoscopic techniques
robotic-assisted laparoscopic surgeryProcedure or surgery
operation that involves use of laparoscopic assistance with robotic assistance
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients undergo standard conventional laparoscopic resection. Receives: Procedure: conventional laparoscopic surgery; Procedure: quality-of-life assessment; Other: questionnaire administration |
| Arm II | Experimental | Patients undergo robotic-assisted laparoscopic resection. Receives: Procedure: robotic-assisted laparoscopic surgery; Procedure: quality-of-life assessment; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of conversion to open surgery as an indicator of surgical technical difficulty
Measured: At completion of surgery
Secondary outcomes (10)
Circumferential resection margin positivity rate
Measured: At completion of pathology review
Local recurrence rate
Measured: At 3 years
Intra-operative and post-operative complications
Measured: At day 30 and 6 months
Operative mortality
Measured: At day 30
Self reported bladder and sexual function
Measured: At day 30 and 6 months
Health related quality of life
Measured: At day 30 and 6 months
Disease free and overall survival
Measured: At 3 years
Intra-operative laparoscopic skills (randomly selected cases only) as assessed by the global assessment tool for evaluation of intra-operative laparoscopic skills (GOALS)
Measured: Upon completion of GOALS assessment by an independent expert
Quality of the plane of surgery as assessed by central review of photographs
Measured: At completion of the central review of photographs
Health economics
Measured: At day 30 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startDec 2011
- Primary completionJul 2013 (estimated)
Why it stopped: The study has never been opened to accrual at COH. Study to be closed at COH due to the lack of qualified robotic colorectal surgeons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Rectal CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessio Pigazzi, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196000
- Sponsor's protocol ID
- 07158
- Other IDs
- NCI-2010-01427
- Status last verified
- Apr 2012
- First submitted
- 3 Sep 2010
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer
- ClinicalTrials.gov ID
- NCT01196000
- Acronym / sponsor ID
- 07158
- Conditions
- Recurrent Rectal Cancer, Stage I Rectal Cancer, Stage II Rectal Cancer, Stage III Rectal Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study has never been opened to accrual at COH. Study to be closed at COH due to the lack of qualified robotic colorectal surgeons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2013 (estimated)
- First posted
- 8 Sep 2010 (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.
RATIONALE: Robotic-assisted laparoscopic surgery may be a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether robotic-assisted laparoscopic surgery is more effective than laparoscopic surgery in treating patients with rectal cancer.
PURPOSE: This randomized clinical trial studies robotic-assisted laparoscopic surgery to see how well it works compared to laparoscopic surgery in treating patients with rectal cancer that can be removed by surgery.
Detailed description
OBJECTIVES:
- To evaluate robotic-assisted rectal cancer surgery versus standard laparoscopic rectal cancer resection by means of a randomized, controlled trial.
II. To assess technical ease of the operation, as determined by the clinical indicator of low conversion rate to open operation.
III. To assess surgical accuracy and improved oncological outcome as determined by clear pathological resection margins.
IV. To assess quality of life and analyze cost-effectiveness to aid evidence-based knowledge to inform NHS and other service providers and decision-makers.
- To analyze disease-free and overall survival and local recurrence rates at 3-year follow-up.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo standard laparoscopic resection.
ARM II: Patients undergo robotic-assisted laparoscopic resection.
After completion of study treatment, patients are followed up at 1 month, 6 months, and then annually thereafter for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Procedure: conventional laparoscopic surgery, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients undergo standard conventional laparoscopic resection. |
| Arm II | Experimental | Procedure: robotic-assisted laparoscopic surgery, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients undergo robotic-assisted laparoscopic resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to provide written informed consent
- Diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection (i.e. staged T1-3, N0-2, M0 by CT and MRI or transrectal ultrasound)
- Rectal cancer suitable for resection by either standard or robotic-assisted laparoscopic procedure
- Fit for robotic-assisted or standard laparoscopic rectal resection
- ASA =< 3
Key exclusion criteria (11 listed)
- Benign lesions of the rectum
- Cancers of the anal canal
- Locally advanced cancers not amenable to curative surgery
- Locally advanced cancers requiring en bloc multi-visceral resection
- Synchronous colorectal tumours requiring multi-segment surgical resection
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 |
|---|---|---|
| conventional laparoscopic surgeryAlso: laparoscopy-assisted surgery, surgery, laparoscopicoperation using conventional laparoscopic techniques | Procedure or surgery | Arm I |
| robotic-assisted laparoscopic surgeryoperation that involves use of laparoscopic assistance with robotic assistance | Procedure or surgery | Arm II |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I, Arm II |
| questionnaire administrationAncillary studies | Other | Arm I, Arm II |
Primary outcome
Rate of conversion to open surgery as an indicator of surgical technical difficulty
Time frame: At completion of surgery
10 secondary outcomes
Circumferential resection margin positivity rate
Time frame: At completion of pathology review
Local recurrence rate
Time frame: At 3 years
Intra-operative and post-operative complications
Time frame: At day 30 and 6 months
Operative mortality
Time frame: At day 30
Self reported bladder and sexual function
Time frame: At day 30 and 6 months
Health related quality of life
Time frame: At day 30 and 6 months
Disease free and overall survival
Time frame: At 3 years
Intra-operative laparoscopic skills (randomly selected cases only) as assessed by the global assessment tool for evaluation of intra-operative laparoscopic skills (GOALS)
Time frame: Upon completion of GOALS assessment by an independent expert
Quality of the plane of surgery as assessed by central review of photographs
Time frame: At completion of the central review of photographs
Health economics
Time frame: At day 30 and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 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.
Alessio Pigazzi principal investigator
City of Hope Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing conventional laparoscopic surgery, robotic-assisted laparoscopic surgery and quality-of-life assessment in people with Recurrent Rectal Cancer and Stage I Rectal Cancer, run by City of Hope Medical Center.
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 6 inclusion and 11 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: withdrawn, as of the sponsor's last update on 17 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of conversion to open surgery as an indicator of surgical technical difficulty (time frame: At completion of surgery). 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 17 Apr 2012.