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Procedure RACHEL in Complex Treatment of Rectal Cancer (RACHEL)

Primary Purpose

Rectal Cancer T3-4N0-2M0

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
usual rectal cancer surgery
RACHEL
Sponsored by
Voronezh N.N. Burdenko State Medical Academy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer T3-4N0-2M0 focused on measuring rectal cancer, RACHEL, oil chemoembolization

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Voronezh Regional Hospital #1

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rectal cancer, surgery

rectal cancer, RACHEL, surgery

Arm Description

Outcomes

Primary Outcome Measures

tumor reduction

Secondary Outcome Measures

Full Information

First Posted
December 19, 2013
Last Updated
December 27, 2013
Sponsor
Voronezh N.N. Burdenko State Medical Academy
Collaborators
Voronesh Regional Clinical Hospital #1
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1. Study Identification

Unique Protocol Identification Number
NCT02022553
Brief Title
Procedure RACHEL in Complex Treatment of Rectal Cancer
Acronym
RACHEL
Official Title
Complex Treatment of Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Voronezh N.N. Burdenko State Medical Academy
Collaborators
Voronesh Regional Clinical Hospital #1

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer T3-4N0-2M0
Keywords
rectal cancer, RACHEL, oil chemoembolization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rectal cancer, surgery
Arm Type
Experimental
Arm Title
rectal cancer, RACHEL, surgery
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
usual rectal cancer surgery
Intervention Type
Procedure
Intervention Name(s)
RACHEL
Other Intervention Name(s)
selective endoarterial oil chemoembolisation of upper, middle and lower rectal arteries
Primary Outcome Measure Information:
Title
tumor reduction
Time Frame
5-10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Facility Information:
Facility Name
Voronezh Regional Hospital #1
City
Voronezh
State/Province
Voronezh region
ZIP/Postal Code
394066
Country
Russian Federation

12. IPD Sharing Statement

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Procedure RACHEL in Complex Treatment of Rectal Cancer

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