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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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
- 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.
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
|Contact: Min Wang, M.D.||(+86)firstname.lastname@example.org|
|Contact: Wangsheng Xue||(+86)email@example.com|
|The Second Hospital of Jilin University||Recruiting|
|Changchun, Jilin, China, 130041|
|Contact: Min Wang, M.D. +86 13074373336 firstname.lastname@example.org|