Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Radiation: Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany）

• Registration Number: NCT03209336
• Lead Sponsor: Second Hospital of Jilin University

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.

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2017-06-30
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-05
• Last Update Submitted: 2017-07-05
• Study First Posted: 2017-07-06
• Last Update Posted: 2017-07-06
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A group	Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany）	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.

Primary Outcome Measures

Name	Time	Method
Decide and record the region of radiotherapy	Intraoperation	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)	baseline	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

Name	Time	Method
The short-term complications	1 year after operation	The short-term complications(seroma,wound dehiscence and bleeding hematomas)will be followed up by investigator.
Major Adverse Events	1 year after operation	The local relapse (pelvic pain, bleeding and intestinal obstruction included)or metastasis will be recorded by the investigator

Trial Locations

Locations (1)

The Second Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China