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Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer (IDAVON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03393234
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.

Condition or disease Intervention/treatment
Rectal Cancer Radiation: Interoperative radiation by INTRABEAM using low energy X-ray

Detailed Description:
Inter-sphincteric resection (ISR) has become an increasingly popular optional surgical tool for the treatment of very low rectal cancer. Nowadays, preoperative criteria for Lap ISR were the patients whose diagnosed with clinical stages T1-2 and N0_1, which only a few patients with early stages can benefit from it. However, intra-operative radiotherapy with low energy X ray applied by Intrabeam is becoming an accepted radiotherapy technique for treatment of cancers. The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Patients will be assigned to two different groups and receive intraoperative radiation randomly. The care provider and investigator also don't know the concrete situation of the patients.
Primary Purpose: Treatment
Official Title: Study of Safety and Feasibility of the Intersphincteric Resection With or Without Intraoperative Radiation in Low Rectal Cancer
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A group
Patients who receive interphincteric resection (ISR) in this group will be given extra intraoperative radiation by INTRBEAM using low energy X-ray.
Radiation: Interoperative radiation by INTRABEAM using low energy X-ray
Intrabeam is a mobile Platform for Intraoperative Radiotherapy (IORT) produced by the ZEISS company in Germany.Interoperative radiation by INTRABEAM using low energy X-ray.The Intrabeam PRS appears to be a safe technique for delivering IORT in rectal cancer patients.
No Intervention: B group
Patients who only receive interphincteric resection (ISR) in this group without intraoperative radiation.


Outcome Measures

Primary Outcome Measures :
  1. 3-year disease free survival [ Time Frame: 3 years ]
    Compare 3-year disease free survival in patients with resectable rectal cancer treated with or without radiation.


Secondary Outcome Measures :
  1. local recurrence rate [ Time Frame: 1 years ]
    In our study, no matter whether distant metastases occurred, if there was the presence of any anastomotic, pelvic, or lateral node recurrences recorded by pathologic or clinical examination, we defined it as local recurrence.

  2. R0 resection rate [ Time Frame: 1 years ]
    To calculate the radical resection rate.

  3. sphincter muscle function [ Time Frame: 1 years ]
    Indicated by the anorectal manometry

  4. anorectal manometry [ Time Frame: 1 years ]
    To measure the anus pressure to indirectly reflect the sphincter muscle function

  5. predictive biomarkers [ Time Frame: 3 years ]
    Each follow-up, the biomarkers such as CEA,CA19-9 etc were recorded.

  6. sexual function [ Time Frame: 1 years ]
    Investigated by the questionnaire including the International Index of Erectile dysfunction. (IIEF5)


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • those whom were preoperatively assessed to be in clinical stageT3 or has lymphatic metastasis by MRI or ultrasonic endoscopy;
  • the lower edge of the tumor is away from the anal edge by less than 5 cm, or away from the dentate line by less than 3cm;
  • in intra-operative separation, the lower edge of the tumor is below the plane of the levator ani muscle or the tumor is hard to separate;
  • those in T4 stage and could be radically resected by intra-operative surgeon assessment;
  • adequate preoperative sphincter function and continence; (vi)local spread restricted to the rectal wall or the IAS.
  • absence of distant metastases.

Exclusion Criteria:

  • clinical T4 tumors based on the Union for International Cancer Control UICC TNM classification (7th edition):
  • infiltrating gross appearance of the tumors;
  • poorly differentiated adenocarcinoma by biopsy specimens;
  • a degree of preoperative incontinence.
Contacts and Locations

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): NCT03393234


Contacts
Contact: Min Wang, M.D. (+86)13074373336 jdeywangmin@163.com

Locations
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
More Information

Responsible Party: Second Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT03393234     History of Changes
Other Study ID Numbers: ISR and IORT
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
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)
URL: http://

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:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases