Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer

Rectal Cancer Clinical Trial

— IROT  

Official title:

Single Center Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer in the Standard of Peritoneal Inversion Rectal Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03209336
• Other study ID #: SecondJilinU-IORT
• Status: Recruiting
• Phase: N/A
• First received: June 30, 2017
• Last updated: July 5, 2017
• Start date: January 1, 2015
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2017
• Source: Second Hospital of Jilin University
• Contact: Min Wang, M.D.
• Phone: (+86)13074373336
• Email: jdeywangmin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• Intraoperative radiotherapy by Intrabeam(Zeiss Meditech,Jena,Germany)
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.

Locations

Country	Name	City	State
China	The Second Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Second Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Intraoperation
Primary	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.	baseline
Secondary	Major Adverse Events	The local relapse (pelvic pain, bleeding and intestinal obstruction included)or metastasis will be recorded by the investigator	1 year after operation
Secondary	The short-term complications	The short-term complications(seroma,wound dehiscence and bleeding hematomas)will be followed up by investigator.	1 year after operation