Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Radiation: Interoperative radiation by INTRABEAM using low energy X-ray

• Registration Number: NCT03393234
• Lead Sponsor: Second Hospital of Jilin University

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.

Study Timeline

• Study Start: 2017-06-01
• Status Verified: 2018-01
• Study First Submitted: 2018-01-01
• Study First Submitted QC: 2018-01-05
• Last Update Submitted: 2018-01-05
• Study First Posted: 2018-01-08
• Last Update Posted: 2018-01-08
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
R0 resection rate	1 years	To calculate the radical resection rate.
sphincter muscle function	1 years	Indicated by the anorectal manometry
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.
anorectal manometry	1 years	To measure the anus pressure to indirectly reflect the sphincter muscle function
predictive biomarkers	3 years	Each follow-up, the biomarkers such as CEA,CA19-9 etc were recorded.
sexual function	1 years	Investigated by the questionnaire including the International Index of Erectile dysfunction. (IIEF5)

Trial Locations

Locations (1)

The Second Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China