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
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Radiation: Interoperative radiation by INTRABEAM using low energy X-ray||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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.|
|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|
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.
- 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.
- 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.
- R0 resection rate [ Time Frame: 1 years ]To calculate the radical resection rate.
- sphincter muscle function [ Time Frame: 1 years ]Indicated by the anorectal manometry
- anorectal manometry [ Time Frame: 1 years ]To measure the anus pressure to indirectly reflect the sphincter muscle function
- predictive biomarkers [ Time Frame: 3 years ]Each follow-up, the biomarkers such as CEA,CA19-9 etc were recorded.
- sexual function [ Time Frame: 1 years ]Investigated by the questionnaire including the International Index of Erectile dysfunction. (IIEF5)
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
|Contact: Min Wang, M.D.||(+86)firstname.lastname@example.org|
|The Second Hospital of Jilin University||Recruiting|
|Changchun, Jilin, China, 130041|
|Contact: Min Wang, M.D. +86 13074373336 email@example.com|