Rectal Cancer
Conditions
Keywords
Ultra-low rectal cancer, Intersphincteric resection, IORT
Brief summary
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
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.
Interventions
RADIATIONInteroperative 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.
Sponsors
Second Hospital of Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free survival | 3 years | Compare 3-year disease free survival in patients with resectable rectal cancer treated with or without radiation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local recurrence rate | 1 years | 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. |
| R0 resection rate | 1 years | To calculate the radical resection rate. |
| sphincter muscle function | 1 years | Indicated by the anorectal manometry |
| anorectal manometry | 1 years | To measure the anus pressure to indirectly reflect the sphincter muscle function |
| predictive biomarkers | 3 years | Each follow-up, the biomarkers such as CEA,CA19-9 etc were recorded. |
| sexual function | 1 years | Investigated by the questionnaire including the International Index of Erectile dysfunction. (IIEF5) |
Countries
China
Contacts
Primary ContactMin Wang, M.D.
Outcome results
None listed