Rectal AdenocarcinomaNCT01702116
Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
A study testing extralevator APR and APR in people with Rectal Adenocarcinoma, run by Stony Brook University at 4 sites in United States.
Trial summary
This is a study that compares two types of surgery for rectal cancer. There are two procedures that can be used during this surgery, conventional abdominal resection (APR) and extended (or extralevator) APR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma
- What is being tested?
- extralevator APR and APR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 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
- Resectable, histologically proven primary adenocarcinoma of the low rectum with internal and/or external sphincter muscle involvement. Staged as follows prior to neoadjuvant chemoradiation:
- Stage T3 or T4 at MRI
- N0-2 at MRI
- M0 at CT scan
- Patient must undergo long term neoadjuvant chemoradiation: 20 fractions of radiation over ≥5 weeks: total of 50-60 Gy, and chemotherapeutic agents
Who cannot join
- Squamous cell carcinoma
- Adenocarcinoma Stage T1-2, any N
- T4 with one of the following:
- with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total) Distant metastasis (M1) Unresectable primary rectal cancer or Inability to complete R0 resection. Recurrent rectal cancer Previous pelvic malignancy Inability to sign informed consent Pregnancy
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
State University Hospital Medical Center
Stony Brook, New York, 11794-8191
Roberto Bergamaschi, MD, PhD, 631-444-2704, rbergamaschi@notes.cc.sunysb.edu
Paula Denoya, MD, 631-444-3431, pdenoya@notes.cc.sunysb.edu
- Recruiting
Stony Broook University Medical Center
Stony Brook, New York, 11794-8191
Roberto Bergamaschi, MD, PhD, 631-444-2704, rbergamaschi@notes.cc.sunysb.edu
Paula Denoya, MD, 631-444-3431, pdenoya@notes.cc.sunysb.edu
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
Roberto Bergamaschi, MD, PhD, 631-444-2704, rbergamaschi@notes.cc.sunysb.edu
Roberto Bergamaschi, MD, PhD
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
Roberto Bergamaschi, MD, PhD, 631-444-2704, rbergamaschi@notes.cc.sunysb.edu
Roberto Bergamaschi, MD, PhD
About this study
Official title: Multicenter Randomized Controlled Trial, Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
This is a study that compares two types of surgery for rectal cancer. There are two procedures that can be used during this surgery, conventional abdominal resection (APR) and extended (or extralevator) APR. The investigators are doing this research to see whether the extralevator APR increases the likelihood that the edge of the tissue that is removed will be more likely to be free from cancer cells compared with the conventional APR surgery. At this time there is no evidence that one type of procedure is better at this than the other. The objective of this research is to determine whether extralevator APR is more likely to have clean margins (free of cancer) compared to the standard APR surgery.
- Conditions
- Rectal Adenocarcinoma
- Being tested
- extralevator APR, APR
- Keywords
- rectal adenocarcinoma, Standard APR, Extralevator APR
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extralevator APRProcedure or surgery
Extralevator Abdominoperineal Resection For Rectal Adenocarcinoma. The aim of this modified and more extensive procedure is to remove the levator muscle en bloc with the anal canal and the mesorectum, creating a more "cylindrical" specimen, so that the amount of tissue removed around the tumor will be larger, thereby reducing the probability that the CRM will be positive.
APRProcedure or surgery
standard Abdominoperineal Resection For Rectal Adenocarcinoma
| Study group | Role | What they receive |
|---|---|---|
| extralevator APR | Experimental | This is a modified and more extensive procedure that is used to remove the levator muscle en bloc with the anal canal and the mesorectum, creating a more "cylindrical" specimen, so that the amount of tissue removed around the tumor will be larger, thereby reducing the probability that the CRM will be positive. Receives: Procedure: extralevator APR |
| standard APR | Active comparator | conventional abdominoperineal resection (APR) Receives: Procedure: APR |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of circumferential resection margin
Measurement in millimeters (mm) of the circumferential resection margin.
Measured: 0-10 minutes post surgery
Secondary outcomes (3)
operative time
operative time from skin incision to skin closure
Measured: 4-6 hours
hospital stay
duration of hospital stay (defined as from beginning of surgery to time of discharge, measured in hours)
Measured: from beginning of surgery through discharge, usually 4-5 days
estimated blood loss
estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon)
Measured: 4-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startJul 2011
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal AdenocarcinomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Bergamaschi, Stony Brook University
- Investigators
- Roberto Bergamaschi, MD, PhD, Principal investigator, Stony Brook University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702116
- Sponsor's protocol ID
- APR2011
- Status last verified
- Apr 2013
- First submitted
- 11 Aug 2011
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bianco F, Romano G, Tsarkov P, Stanojevic G, Shroyer K, Giuratrabocchetta S, Bergamaschi R; International Rectal Cancer Study Group. Extralevator with vs nonextralevator abdominoperineal excision for rectal cancer: the RELAPe randomized controlled trial. Colorectal Dis. 2017 Feb;19(2):148-157. doi: 10.1111/codi.13436.
PubMed 27369739
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial, Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01702116
- Acronym / sponsor ID
- APR2011
- Conditions
- Rectal Adenocarcinoma
- Keywords
- rectal adenocarcinoma, Standard APR, Extralevator APR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 5 Oct 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.
This is a study that compares two types of surgery for rectal cancer. There are two procedures that can be used during this surgery, conventional abdominal resection (APR) and extended (or extralevator) APR. The investigators are doing this research to see whether the extralevator APR increases the likelihood that the edge of the tissue that is removed will be more likely to be free from cancer cells compared with the conventional APR surgery. At this time there is no evidence that one type of procedure is better at this than the other. The objective of this research is to determine whether extralevator APR is more likely to have clean margins (free of cancer) compared to the standard APR surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extralevator APR | Experimental | Procedure: extralevator APRThis is a modified and more extensive procedure that is used to remove the levator muscle en bloc with the anal canal and the mesorectum, creating a more "cylindrical" specimen, so that the amount of tissue removed around the tumor will be larger, thereby reducing the probability that the CRM will be positive. |
| standard APR | Active comparator | Procedure: APRconventional abdominoperineal resection (APR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Resectable, histologically proven primary adenocarcinoma of the low rectum with internal and/or external sphincter muscle involvement. Staged as follows prior to neoadjuvant chemoradiation:
- Stage T3 or T4 at MRI
- N0-2 at MRI
- M0 at CT scan
- Patient must undergo long term neoadjuvant chemoradiation: 20 fractions of radiation over ≥5 weeks: total of 50-60 Gy, and chemotherapeutic agents
Key exclusion criteria (4 listed)
- Squamous cell carcinoma
- Adenocarcinoma Stage T1-2, any N
- T4 with one of the following:
- with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total) Distant metastasis (M1) Unresectable primary rectal cancer or Inability to complete R0 resection. Recurrent rectal cancer Previous pelvic malignancy Inability to sign informed consent Pregnancy
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 |
|---|---|---|
| extralevator APRExtralevator Abdominoperineal Resection For Rectal Adenocarcinoma. The aim of this modified and more extensive procedure is to remove the levator muscle en bloc with the anal canal and the mesorectum, creating a more "cylindrical" specimen, so that the amount of tissue removed around the tumor will be larger, thereby reducing the probability that the CRM will be positive. | Procedure or surgery | extralevator APR |
| APRstandard Abdominoperineal Resection For Rectal Adenocarcinoma | Procedure or surgery | standard APR |
Primary outcome
measurement of circumferential resection margin
Time frame: 0-10 minutes post surgery
Measurement in millimeters (mm) of the circumferential resection margin.
3 secondary outcomes
operative time
Time frame: 4-6 hours
hospital stay
Time frame: from beginning of surgery through discharge, usually 4-5 days
estimated blood loss
Time frame: 4-6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
- Derived from this study: PubMed 27369739Bianco F, Romano G, Tsarkov P, Stanojevic G, Shroyer K, Giuratrabocchetta S, Bergamaschi R; International Rectal Cancer Study Group. Extralevator with vs nonextralevator abdominoperineal excision for rectal cancer: the RELAPe randomized controlled trial. Colorectal Dis. 2017 Feb;19(2):148-157. doi: 10.1111/codi.13436.
Related trials for Rectal Adenocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
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.
Roberto Bergamaschi, MD, PhD principal investigator
Stony Brook University Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extralevator APR and APR in people with Rectal Adenocarcinoma, run by Stony Brook University at 4 sites in United States.
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 5 inclusion and 4 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 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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.
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 Roberto Bergamaschi, MD, PhD (631-444-2704, rbergamaschi@notes.cc.sunysb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of circumferential resection margin (time frame: 0-10 minutes post surgery). 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 NCT01702116, which also lists 1 linked publication.
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 25 Apr 2013.