Rectal Cancer T3-4N0-2M0RACHELNCT02022553
Procedure RACHEL in Complex Treatment of Rectal Cancer
A study testing usual rectal cancer surgery and RACHEL in people with Rectal Cancer T3-4N0-2M0, run by Voronezh N.N. Burdenko State Medical Academy at 1 site in Russia.
Trial summary
AIM OF RESEARCH. The aim of our research is to improve the results of the combined treatment of patients with locally advanced rectal cancer using endovascular methods and reservoir and plastic surgery. TASKS OF RESEARCH. 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer T3-4N0-2M0
- What is being tested?
- usual rectal cancer surgery and RACHEL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2006to Dec 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of rectal cancer T3-4N0-2M0
- complication of bowel obstruction
- No allergy on contrast agent
- Previously not operated about rectal cancer
- Not older than 75 years
Who cannot join
- Older 75 years
- Previously operated about rectal cancer
- Allergy to contrast agent
- No bowel obstruction
- No rectal cancer
- No locally advanced rectal cancer
- Clinical diagnosis of rectal cancer Tis-4N0-2M1 (generalized rectal cancer)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complex Treatment of Rectal Cancer
AIM OF RESEARCH. The aim of our research is to improve the results of the combined treatment of patients with locally advanced rectal cancer using endovascular methods and reservoir and plastic surgery.
TASKS OF RESEARCH.
Read more
- To assess the immediate and long-term results of combined (chemoradiation and surgical) treatment for locally advanced rectal cancer.
- To make a comparative evaluation of the results of independent surgical and combined (chemoradiation and surgery) treatment of patients with locally advanced rectal cancer.
- To examine functional results of surgical treatment with the formation of "neosphincter" and "neorectum" in patients with colorectal cancer..
- To study features of blood supply to the rectum from the pools of the inferior mesenteric and internal iliac arteries, using the method of selective angiography, in connection with the development of endovascular treatment of rectal cancer.
- To develop and introduce into clinical practice method of one-stage selective intra-arterial oil chemoembolization of upper, middle and lower rectal arteries in patients with locally advanced rectal cancer, who have a contraindication to preoperative radiotherapy.
- To assess the immediate and long-term results of combined (endovascular and surgical) treatment for locally advanced rectal cancer.
- To optimize tactics of combined treatment of locally advanced rectal cancer by developing an algorithm of using chemoradiotherapy and endovascular interventions in the preoperative period.
NOVELTY OF RESEARCH.
- As a result of research will be designed and implemented a new method of selective intra-arterial chemoembolization in rectal arteries preoperatively in patients with locally advanced rectal cancer.
- Substantiated high effectiveness of the proposed technique for the removal of colonic obstruction and, as a consequence perform radical surgical treatment of these patients.
- First developed dosage and concentration of chemotherapeutic agent and embolic agent for safe injection when performing selective intra-arterial chemoembolization of rectal arteries.
- Developed complex techniques of selective intra-arterial chemoembolization of rectal arteries preoperatively in patients with locally advanced rectal cancer.
- Will be made a comparative analysis of the postoperative period and the evaluation of the quality of life of operated patients Obtained data will be presented for use in clinical practice. POSSIBLE APPLICATION AREAS. Results of the research designed for use in the treatment process of departments of Coloproctology, oncology, as well as the educational process of higher and secondary medical institutions.
EXPECTED EFFECTIVENESS.
It is expected that the use of this method of treatment of patients with locally advanced rectal cancer in clinical practice will provide pronounced effect:
- Medical and social - improving the quality of care, preservation of social activity of patients, reducing mortality;
- Economic - reducing the time of patients' treatment and reducing the number of therapeutic manipulation;
- Science and Technology - improving of the training level of medicine workers in the treatment of patients with rectal cancer.
- Conditions
- Rectal Cancer T3-4N0-2M0
- Being tested
- usual rectal cancer surgery, RACHEL
- Keywords
- rectal cancer, RACHEL, oil chemoembolization
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual rectal cancer surgeryProcedure or surgery
RACHELProcedure or surgery
Also called selective endoarterial oil chemoembolisation of upper, middle and lower rectal arteries
| Study group | Role | What they receive |
|---|---|---|
| rectal cancer, surgery | Experimental | Not described Receives: Procedure: usual rectal cancer surgery |
| rectal cancer, RACHEL, surgery | Active comparator | Not described Receives: Procedure: RACHEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor reduction
Measured: 5-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startFeb 2006
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer T3-4N0-2M0Studies 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Voronezh N.N. Burdenko State Medical Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Korotkich Nikolay Nikolaevich, Voronezh N.N. Burdenko State Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022553
- Sponsor's protocol ID
- NNKOR2013
- Acronym
- RACHEL
- Status last verified
- May 2024
- First submitted
- 19 Dec 2013
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Treatment of Rectal Cancer
- ClinicalTrials.gov ID
- NCT02022553
- Acronym / sponsor ID
- RACHEL / NNKOR2013
- Conditions
- Rectal Cancer T3-4N0-2M0
- Keywords
- rectal cancer, RACHEL, oil chemoembolization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Voronezh N.N. Burdenko State Medical AcademyUniversity, hospital or other
- Study start
- Feb 2006 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 Dec 2013 (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.
AIM OF RESEARCH. The aim of our research is to improve the results of the combined treatment of patients with locally advanced rectal cancer using endovascular methods and reservoir and plastic surgery.
TASKS OF RESEARCH.
- To assess the immediate and long-term results of combined (chemoradiation and surgical) treatment for locally advanced rectal cancer.
- To make a comparative evaluation of the results of independent surgical and combined (chemoradiation and surgery) treatment of patients with locally advanced rectal cancer.
- To examine functional results of surgical treatment with the formation of "neosphincter" and "neorectum" in patients with colorectal cancer..
- To study features of blood supply to the rectum from the pools of the inferior mesenteric and internal iliac arteries, using the method of selective angiography, in connection with the development of endovascular treatment of rectal cancer.
- To develop and introduce into clinical practice method of one-stage selective intra-arterial oil chemoembolization of upper, middle and lower rectal arteries in patients with locally advanced rectal cancer, who have a contraindication to preoperative radiotherapy.
- To assess the immediate and long-term results of combined (endovascular and surgical) treatment for locally advanced rectal cancer.
- To optimize tactics of combined treatment of locally advanced rectal cancer by developing an algorithm of using chemoradiotherapy and endovascular interventions in the preoperative period.
NOVELTY OF RESEARCH.
- As a result of research will be designed and implemented a new method of selective intra-arterial chemoembolization in rectal arteries preoperatively in patients with locally advanced rectal cancer.
- Substantiated high effectiveness of the proposed technique for the removal of colonic obstruction and, as a consequence perform radical surgical treatment of these patients.
- First developed dosage and concentration of chemotherapeutic agent and embolic agent for safe injection when performing selective intra-arterial chemoembolization of rectal arteries.
- Developed complex techniques of selective intra-arterial chemoembolization of rectal arteries preoperatively in patients with locally advanced rectal cancer.
- Will be made a comparative analysis of the postoperative period and the evaluation of the quality of life of operated patients Obtained data will be presented for use in clinical practice. POSSIBLE APPLICATION AREAS. Results of the research designed for use in the treatment process of departments of Coloproctology, oncology, as well as the educational process of higher and secondary medical institutions.
EXPECTED EFFECTIVENESS.
It is expected that the use of this method of treatment of patients with locally advanced rectal cancer in clinical practice will provide pronounced effect:
- Medical and social - improving the quality of care, preservation of social activity of patients, reducing mortality;
- Economic - reducing the time of patients' treatment and reducing the number of therapeutic manipulation;
- Science and Technology - improving of the training level of medicine workers in the treatment of patients with rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rectal cancer, surgery | Experimental | Procedure: usual rectal cancer surgery |
| rectal cancer, RACHEL, surgery | Active comparator | Procedure: RACHEL |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of rectal cancer T3-4N0-2M0
- complication of bowel obstruction
- No allergy on contrast agent
- Previously not operated about rectal cancer
- Not older than 75 years
Key exclusion criteria (7 listed)
- Older 75 years
- Previously operated about rectal cancer
- Allergy to contrast agent
- No bowel obstruction
- No 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 |
|---|---|---|
| usual rectal cancer surgery | Procedure or surgery | rectal cancer, surgery |
| RACHELAlso: selective endoarterial oil chemoembolisation of upper, middle and lower rectal arteries | Procedure or surgery | rectal cancer, RACHEL, surgery |
Primary outcome
tumor reduction
Time frame: 5-10 days
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 6 May 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing usual rectal cancer surgery and RACHEL in people with Rectal Cancer T3-4N0-2M0, run by Voronezh N.N. Burdenko State Medical Academy at 1 site in Russia.
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 7 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 6 May 2024. 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 Russia. 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?
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?
tumor reduction (time frame: 5-10 days). 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 6 May 2024.