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Spots Global Cancer Trial Database for Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer

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Trial Identification

Brief Title: Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer

Official Title: Single Center Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer in the Standard of Peritoneal Inversion Rectal Cancer.

Study ID: NCT03209336

Conditions

Rectal Cancer

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 40 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

The Second Hospital of Jilin University, Changchun, Jilin, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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