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Trial record 21 of 1545 for:    rectal cancer

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

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ClinicalTrials.gov Identifier: NCT03209336
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Rectal Cancer Radiation: Intraoperative radiotherapy by Intrabeam(Zeiss Meditech,Jena,Germany) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Center Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer in the Standard of Peritoneal Inversion Rectal Cancer.
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

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.



Primary Outcome Measures :
  1. Decide and record the region of radiotherapy [ Time Frame: 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.

  2. The basic information and medical history achieved (questionnaire) [ Time Frame: 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 :
  1. Major Adverse Events [ Time Frame: 1 year after operation ]
    The local relapse (pelvic pain, bleeding and intestinal obstruction included)or metastasis will be recorded by the investigator

  2. The short-term complications [ Time Frame: 1 year after operation ]
    The short-term complications(seroma,wound dehiscence and bleeding hematomas)will be followed up by investigator.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209336


Contacts
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Contact: Min Wang, M.D. (+86)13074373336 jdeywangmin@163.com
Contact: Wangsheng Xue (+86)17625642616 907588917@qq.com

Locations
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China, Jilin
The Second Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130041
Contact: Min Wang, M.D.    +86 13074373336    jdeywangmin@163.com   
Sponsors and Collaborators
Second Hospital of Jilin University

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Responsible Party: Second Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT03209336     History of Changes
Other Study ID Numbers: SecondJilinU-IORT
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: When the investigators complete the study and publish our data.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: When the investigators complete the study and publish our data.

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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
Keywords provided by Second Hospital of Jilin University:
Ultra-low rectal cancer
Intersphincteric resection
IORT
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases