RECTAL CANCERPhase 3NCT00782457
Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer
A Phase 3 study testing RECTAL CANCER RESECTION in people with RECTAL CANCER, run by Hospital Universitario Virgen de la Arrixaca.
Trial summary
The aim of this study is to compare laparoscopic versus open approach on the surgical treatment of mid and low-lying rectal cancer, both performed by the same surgical team with experience in open colorectal surgery and advanced laparoscopic surgery, assessing preoperative and anatomopathological results and long-term… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- RECTAL CANCER
- What is being tested?
- RECTAL CANCER RESECTION
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Dec 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mid- and low-lying rectal cancer (between 0 and 11 cm from the anal margin)
- Histology of adenocarcinoma
Who cannot join
- Locally advanced disease (T4)
- Emergency surgery
- Rectal cancer over familial colic polyposis
About this study
The aim of this study is to compare laparoscopic versus open approach on the surgical treatment of mid and low-lying rectal cancer, both performed by the same surgical team with experience in open colorectal surgery and advanced laparoscopic surgery, assessing preoperative and anatomopathological results and long-term outcome.
- Conditions
- RECTAL CANCER
- Being tested
- RECTAL CANCER RESECTION
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECTAL CANCER RESECTIONProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| OPEN SURGERY | Active comparator | Not described Receives: Procedure: RECTAL CANCER RESECTION |
| LAPAROSCOPIC SURGERY | Experimental | Not described Receives: Procedure: RECTAL CANCER RESECTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJan 2002
- Primary completionFeb 2007
- Study completionDec 2010
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 CANCERStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782457
- Sponsor's protocol ID
- D-08-00770
- Status last verified
- Oct 2008
- First submitted
- 29 Oct 2008
- Last updated
- 18 Mar 2015
- Results posted
- No
Publications
Lujan J, Valero G, Hernandez Q, Sanchez A, Frutos MD, Parrilla P. Randomized clinical trial comparing laparoscopic and open surgery in patients with rectal cancer. Br J Surg. 2009 Sep;96(9):982-9. doi: 10.1002/bjs.6662.
PubMed 19644973
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer
- ClinicalTrials.gov ID
- NCT00782457
- Acronym / sponsor ID
- D-08-00770
- Conditions
- RECTAL CANCER
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Feb 2007 (actual)
- Study completion
- Dec 2010
- First posted
- 31 Oct 2008 (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.
The aim of this study is to compare laparoscopic versus open approach on the surgical treatment of mid and low-lying rectal cancer, both performed by the same surgical team with experience in open colorectal surgery and advanced laparoscopic surgery, assessing preoperative and anatomopathological results and long-term outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPEN SURGERY | Active comparator | Procedure: RECTAL CANCER RESECTION |
| LAPAROSCOPIC SURGERY | Experimental | Procedure: RECTAL CANCER RESECTION |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Mid- and low-lying rectal cancer (between 0 and 11 cm from the anal margin)
- Histology of adenocarcinoma
Key exclusion criteria (3 listed)
- Locally advanced disease (T4)
- Emergency surgery
- Rectal cancer over familial colic polyposis
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 |
|---|---|---|
| RECTAL CANCER RESECTION | Procedure or surgery | LAPAROSCOPIC SURGERY, OPEN SURGERY |
Primary outcome
Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Derived from this study: PubMed 19644973Lujan J, Valero G, Hernandez Q, Sanchez A, Frutos MD, Parrilla P. Randomized clinical trial comparing laparoscopic and open surgery in patients with rectal cancer. Br J Surg. 2009 Sep;96(9):982-9. doi: 10.1002/bjs.6662.
Related trials for RECTAL CANCER
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
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
Active, not recruitingPhase 3
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RECTAL CANCER RESECTION in people with RECTAL CANCER, run by Hospital Universitario Virgen de la Arrixaca.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Mar 2015. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay (time frame: 1 month). 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 NCT00782457, 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 18 Mar 2015.