Clinical trial · Interventional
Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer
Study of Safety and Feasibility of the Intersphincteric Resection With or Without Intraoperative Radiation in Low Rectal Cancer
NCT03393234CI-TRIAL-00031059IDAVONunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interoperative radiation by INTRABEAM using low energy X-ray | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A group
- description
- Patients who receive interphincteric resection (ISR) in this group will be given extra intraoperative radiation by INTRBEAM using low energy X-ray.
- interventionNames
- Radiation: Interoperative radiation by INTRABEAM using low energy X-ray
- type
- NO_INTERVENTION
- label
- B group
- description
- Patients who only receive interphincteric resection (ISR) in this group without intraoperative radiation.
Primary outcomes (1)
- measure
- 3-year disease free survival
- timeFrame
- 3 years
- description
- Compare 3-year disease free survival in patients with resectable rectal cancer treated with or without radiation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWang 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. PMID 29981575