Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer (IROT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer
• Intervention / Treatment: Radiation: Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany）

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wangsheng Xue; Phone Number: (+86)17625642616; Email: 907588917@qq.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130041
      • Recruiting
      • The Second Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A group; 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.	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.
NO_INTERVENTION: B group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The short-term complications	The short-term complications(seroma,wound dehiscence and bleeding hematomas)will be followed up by investigator.	1 year after operation

Collaborators and Investigators

• Sponsor: Second Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ANTICIPATED): December 30, 2020
• Study Completion (ANTICIPATED): December 30, 2020

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (ACTUAL): July 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: IORT; Ultra-low rectal cancer; Intersphincteric resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: SecondJilinU-IORT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• 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