Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer (IROT)
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intraoperative radiotherapy by Intrabeam(Zeiss Meditech,Jena,Germany)
Sponsored by
![Second Hospital of Jilin University](https://trials-media.s3.amazonaws.com/orgs/second-hospital-of-jilin-university.jpeg)
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring Ultra-low rectal cancer, Intersphincteric resection, IORT
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria:
- Aged 40 to 80 years old, gender not limited.
- Be diagnosed as colorectal cancer by coloscopy.
- Patients with middle and low rectal cancer,whose preoperative staging evaluation is T3 ,T4 or N+.
- Accept surgery and intraoperative radiotherapy.
- Signed informed consent
Exclusion Criteria:
- the patients whose preoperative evaluation is below T3 stage with middle and rectal cancer.
- Active internal bleeding (such as gastrointestinal bleeding), urogenital system, or have not cure of peptic ulcer in four weeks
- Severe liver and kidney dysfunction
- Intracranial tumor, suspicious aortic dissection, arteriovenous malformation, aneurysm
- Thrombolysis treatment in one week
- Allergies of thrombolysis drug or contrast
- Participated in any clinical trials within three months
Sites / Locations
- The Second Hospital of Jilin UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A group
B group
Arm Description
Colorectal cancer patients first are given antineoplastic drugs and then transfer to operative room to be treated by surgical resection and the radiotherapy is given during the operation after the removal of the tumour.
Colorectal cancer patients first are given antineoplastic drugs and then transfer to operative room to be treated only by surgical resection and no radiotherapy afer the removal of the tumour.
Outcomes
Primary Outcome Measures
Decide and record the region of radiotherapy
The operator will confirm and record the range of intrabeam after removal of tumor such as the length and height to modify the dose and the time of intrabeam.
The basic information and medical history achieved (questionnaire)
Investigators will take a overall information about the patients including the physical condition,history of present illness,family genetic history etc;Then the information will be recorded in a format to develop a statistic analysis.
Secondary Outcome Measures
Major Adverse Events
The local relapse (pelvic pain, bleeding and intestinal obstruction included)or metastasis will be recorded by the investigator
The short-term complications
The short-term complications(seroma,wound dehiscence and bleeding hematomas)will be followed up by investigator.
Full Information
NCT ID
NCT03209336
First Posted
June 30, 2017
Last Updated
July 5, 2017
Sponsor
Second Hospital of Jilin University
1. Study Identification
Unique Protocol Identification Number
NCT03209336
Brief Title
Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer
Acronym
IROT
Official Title
Single Center Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer in the Standard of Peritoneal Inversion Rectal Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Hospital of Jilin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study the application of Intersphincteric Resection(ISR)combined with intraoperative radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications of Intersphincteric Resection(ISR.
The study is aimed to assess the postoperative acute complication and the short-term acute efficacy on the patients with middle and low rectal cancer by treated with intraoperative radiotherapy,especially those with peritoneal inversion rectal cancer.
Detailed Description
Abstract objective: To study the application of Intersphincteric Resection(ISR)combined with intraoperative radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications of Intersphincteric Resection(ISR).
Methods: Patients, who were diagnosed with ultra-low rectal cancer and had strong desire of preserving anal function, will take part in the research,whose tumor invading the levator ani muscle or above, the diameter less than 6cm, the lower tumor margin away from the anal verge by less than 5cm and away from the dentate line by less than 3cm.They will undergo total mesorectal excision(TME) and ISR combined with IORT and prophylactic ileostomy.
Outcomes Measures:The evaluation of short term effects includes complications such as anastomotic leakage, acute radiation injury ,urinary dysfunction ,dysfunction of anal sphincter ,sexual dysfunction ,local recurrence , total life expectancy and expectancy without metastasis. The postoperative pathological examination reported to be moderately differentiated adenocarcinoma .We wili assess their postoperative acute complications and short-term efficacy .Their time of follow up visit wil be 1 year or more.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Ultra-low rectal cancer, Intersphincteric resection, IORT
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
A group
Arm Type
Experimental
Arm Description
Colorectal cancer patients first are given antineoplastic drugs and then transfer to operative room to be treated by surgical resection and the radiotherapy is given during the operation after the removal of the tumour.
Arm Title
B group
Arm Type
No Intervention
Arm Description
Colorectal cancer patients first are given antineoplastic drugs and then transfer to operative room to be treated only by surgical resection and no radiotherapy afer the removal of the tumour.
Intervention Type
Radiation
Intervention Name(s)
Intraoperative radiotherapy by Intrabeam(Zeiss Meditech,Jena,Germany)
Intervention Description
We confirmed that if the patients had the distant metastasis before IORT. The median radiation dose was 5.00 Gy (range: 5.00-10.00Gy), the average dose was 6.00 Gy. The median radiation time was 0:33:24 (range: 0:21:45-1:06:23), which was the same with the patients'. All patients' surface dose ranged from 15.00 to 28.50 Gy.
Primary Outcome Measure Information:
Title
Decide and record the region of radiotherapy
Description
The operator will confirm and record the range of intrabeam after removal of tumor such as the length and height to modify the dose and the time of intrabeam.
Time Frame
Intraoperation
Title
The basic information and medical history achieved (questionnaire)
Description
Investigators will take a overall information about the patients including the physical condition,history of present illness,family genetic history etc;Then the information will be recorded in a format to develop a statistic analysis.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Major Adverse Events
Description
The local relapse (pelvic pain, bleeding and intestinal obstruction included)or metastasis will be recorded by the investigator
Time Frame
1 year after operation
Title
The short-term complications
Description
The short-term complications(seroma,wound dehiscence and bleeding hematomas)will be followed up by investigator.
Time Frame
1 year after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria:
Aged 40 to 80 years old, gender not limited.
Be diagnosed as colorectal cancer by coloscopy.
Patients with middle and low rectal cancer,whose preoperative staging evaluation is T3 ,T4 or N+.
Accept surgery and intraoperative radiotherapy.
Signed informed consent
Exclusion Criteria:
the patients whose preoperative evaluation is below T3 stage with middle and rectal cancer.
Active internal bleeding (such as gastrointestinal bleeding), urogenital system, or have not cure of peptic ulcer in four weeks
Severe liver and kidney dysfunction
Intracranial tumor, suspicious aortic dissection, arteriovenous malformation, aneurysm
Thrombolysis treatment in one week
Allergies of thrombolysis drug or contrast
Participated in any clinical trials within three months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Wang, M.D.
Phone
(+86)13074373336
Email
jdeywangmin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wangsheng Xue
Phone
(+86)17625642616
Email
907588917@qq.com
Facility Information:
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Wang, M.D.
Phone
+86 13074373336
Email
jdeywangmin@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
When the investigators complete the study and publish our data.
IPD Sharing Time Frame
When the investigators complete the study and publish our data.
Learn more about this trial
Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer
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