Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer

Rectal Cancer Clinical Trial

— IDAVON  

Official title:

Study of Safety and Feasibility of the Intersphincteric Resection With or Without Intraoperative Radiation in Low Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03393234
• Other study ID #: ISR and IORT
• Status: Recruiting
• Phase: N/A
• First received: January 1, 2018
• Last updated: January 5, 2018
• Start date: June 1, 2017
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2018
• Source: Second Hospital of Jilin University
• Contact: Min Wang, M.D.
• Phone: (+86)13074373336
• Email: jdeywangmin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	The Second Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Second Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival	Compare 3-year disease free survival in patients with resectable rectal cancer treated with or without radiation.	3 years
Secondary	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.	1 years
Secondary	R0 resection rate	To calculate the radical resection rate.	1 years
Secondary	sphincter muscle function	Indicated by the anorectal manometry	1 years
Secondary	anorectal manometry	To measure the anus pressure to indirectly reflect the sphincter muscle function	1 years
Secondary	predictive biomarkers	Each follow-up, the biomarkers such as CEA,CA19-9 etc were recorded.	3 years
Secondary	sexual function	Investigated by the questionnaire including the International Index of Erectile dysfunction. (IIEF5)	1 years