Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Radiation: Interoperative radiation by INTRABEAM using low energy X-ray


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A group<br>Patients who receive interphincteric resection (ISR) in this group will be given extra intraoperative radiation by INTRBEAM using low energy X-ray. | Radiation: Interoperative radiation by INTRABEAM using low energy X-ray<br>* 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.<br>|
| No Intervention: B group<br>Patients who only receive interphincteric resection (ISR) in this group without intraoperative radiation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IORT, Ultra-low rectal cancer, Intersphincteric resection