Clinical trial NCT03393234: Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer
Official title: Study of Safety and Feasibility of the Intersphincteric Resection With or Without Intraoperative Radiation in Low Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: Ultra-low rectal cancer
Intersphincteric resection
IORT
Lead sponsor: Second Hospital of Jilin University
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 3-year disease free survival
timeFrame: 3 years
Secondary outcomes:
measure: local recurrence rate
timeFrame: 1 years
measure: R0 resection rate
timeFrame: 1 years
measure: sphincter muscle function
timeFrame: 1 years
measure: anorectal manometry
timeFrame: 1 years
measure: predictive biomarkers
timeFrame: 3 years
measure: sexual function
timeFrame: 1 years
Other outcomes:
Locations:
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
Study officials:
References:
citation: Wang M, Xue W, Zhao Z, Li Y, Wang X, Li T, Zou Y, Song X, Zhang M, Wang T, Yang J, Wang C, Wang S. Laparoscopic intersphincteric resection with intraoperative radiotherapy using low-energy X-rays for locally advanced ultra-low rectal cancer. World J Surg Oncol. 2018 Jul 7;16(1):133. doi: 10.1186/s12957-018-1430-6.