Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2022-01-01

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.

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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.

Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Patients will be assigned to two different groups and receive intraoperative radiation randomly. The care provider and investigator also don't know the concrete situation of the patients.

Study Groups

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A group

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

Group Type EXPERIMENTAL

Interoperative radiation by INTRABEAM using low energy X-ray

Intervention Type RADIATION

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.

B group

Patients who only receive interphincteric resection (ISR) in this group without intraoperative radiation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Interoperative radiation by INTRABEAM using low energy X-ray

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.

Intervention Type RADIATION

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No