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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group | Experimental | Patients who receive interphincteric resection (ISR) in this group will be given extra intraoperative radiation by INTRBEAM using low energy X-ray. |
|
| B group | No Intervention | Patients who only receive interphincteric resection (ISR) in this group without intraoperative radiation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interoperative radiation by INTRABEAM using low energy X-ray | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Wang, M.D. | Contact | (+86)13074373336 | jdeywangmin@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Jilin University | Recruiting | Changchun | Jilin | 130041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29981575 | Derived | 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. |
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When the investigators complete the study and publish our data.
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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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.
|
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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |