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

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Interoperative radiation by INTRABEAM using low energy X-ray
Sponsored by
Second Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Ultra-low rectal cancer, Intersphincteric resection, IORT

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A group

B group

Arm Description

Patients who receive interphincteric resection (ISR) in this group will be given extra intraoperative radiation by INTRBEAM using low energy X-ray.

Patients who only receive interphincteric resection (ISR) in this group without intraoperative radiation.

Outcomes

Primary Outcome Measures

3-year disease free survival
Compare 3-year disease free survival in patients with resectable rectal cancer treated with or without radiation.

Secondary Outcome Measures

local recurrence rate
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.
R0 resection rate
To calculate the radical resection rate.
sphincter muscle function
Indicated by the anorectal manometry
anorectal manometry
To measure the anus pressure to indirectly reflect the sphincter muscle function
predictive biomarkers
Each follow-up, the biomarkers such as CEA,CA19-9 etc were recorded.
sexual function
Investigated by the questionnaire including the International Index of Erectile dysfunction. (IIEF5)

Full Information

First Posted
January 1, 2018
Last Updated
January 5, 2018
Sponsor
Second Hospital of Jilin University
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1. Study Identification

Unique Protocol Identification Number
NCT03393234
Brief Title
Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer
Acronym
IDAVON
Official Title
Study of Safety and Feasibility of the Intersphincteric Resection With or Without Intraoperative Radiation in Low Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Hospital of Jilin University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Ultra-low rectal cancer, Intersphincteric resection, IORT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A group
Arm Type
Experimental
Arm Description
Patients who receive interphincteric resection (ISR) in this group will be given extra intraoperative radiation by INTRBEAM using low energy X-ray.
Arm Title
B group
Arm Type
No Intervention
Arm Description
Patients who only receive interphincteric resection (ISR) in this group without intraoperative radiation.
Intervention Type
Radiation
Intervention Name(s)
Interoperative radiation by INTRABEAM using low energy X-ray
Intervention Description
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.
Primary Outcome Measure Information:
Title
3-year disease free survival
Description
Compare 3-year disease free survival in patients with resectable rectal cancer treated with or without radiation.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
local recurrence rate
Description
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.
Time Frame
1 years
Title
R0 resection rate
Description
To calculate the radical resection rate.
Time Frame
1 years
Title
sphincter muscle function
Description
Indicated by the anorectal manometry
Time Frame
1 years
Title
anorectal manometry
Description
To measure the anus pressure to indirectly reflect the sphincter muscle function
Time Frame
1 years
Title
predictive biomarkers
Description
Each follow-up, the biomarkers such as CEA,CA19-9 etc were recorded.
Time Frame
3 years
Title
sexual function
Description
Investigated by the questionnaire including the International Index of Erectile dysfunction. (IIEF5)
Time Frame
1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Wang, M.D.
Phone
(+86)13074373336
Email
jdeywangmin@163.com
Facility Information:
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Wang, M.D.
Phone
+86 13074373336
Email
jdeywangmin@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
When the investigators complete the study and publish our data.
Citations:
PubMed Identifier
29981575
Citation
Wang M, Xue W, Zhao Z, Li Y, Wang X, Li T, Zou Y, Song X, Zhang M, Wang T, Yang J, Wang C, Wang S. Laparoscopic intersphincteric resection with intraoperative radiotherapy using low-energy X-rays for locally advanced ultra-low rectal cancer. World J Surg Oncol. 2018 Jul 7;16(1):133. doi: 10.1186/s12957-018-1430-6.
Results Reference
derived

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Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer

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