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IDAVON: Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer

Sponsor
Second Hospital of Jilin University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03393234
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
55
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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 Phase
  • Radiation: Interoperative radiation by INTRABEAM using low energy X-ray
 N/A

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
Anticipated 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 :
Jun 1, 2017
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2022

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 [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 [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 [1 years]

    To calculate the radical resection rate.

  3. sphincter muscle function [1 years]

    Indicated by the anorectal manometry

  4. anorectal manometry [1 years]

    To measure the anus pressure to indirectly reflect the sphincter muscle function

  5. predictive biomarkers [3 years]

    Each follow-up, the biomarkers such as CEA,CA19-9 etc were recorded.

  6. sexual function [1 years]

    Investigated by the questionnaire including the International Index of Erectile dysfunction. (IIEF5)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 The Second Hospital of Jilin University Changchun Jilin China 130041

Sponsors and Collaborators

  • Second Hospital of Jilin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Hospital of Jilin University
ClinicalTrials.gov Identifier:
NCT03393234
Other Study ID Numbers:
  • ISR and IORT
First Posted:
Jan 8, 2018
Last Update Posted:
Jan 8, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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

Study Results

No Results Posted as of Jan 8, 2018