Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer (IDAVON)

Jilin University

Status

Unknown

Conditions

Rectal Cancer

Treatments

Radiation: Interoperative radiation by INTRABEAM using low energy X-ray

Study type

Interventional

Funder types

Other

Identifiers

NCT03393234

ISR and IORT

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.