Clinical trial · Interventional
IORT in Local Advanced Laryngocarcinoma
Study of Safety and Feasibility With or Without Intraoperative Radiation in Local Advanced Laryngocarcinoma
- 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 incidence of laryngeal cancer accounts for about 1 \~ 5% of the total body tumors. For the surgical treatment of laryngeal cancer, the development trend of laryngocarcinoma treatment is to improve the local control rate, preserve the laryngeal function of patients as far as possible, and improve the life quality of patients. The efficacy, safety and feasibility of intraoperative radiotherapy (IORT) in head and neck cancer has been demonstrated in multiple institutional (3-5) studies to optimize local control. It is still unclear whether IORT can improve the local control and have efficacy, safety and feasibility in clinic. The purpose of this study was to observe the efficacy, safety and feasibility of IORT in local advanced laryngocarcinoma .
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 |
|---|---|---|---|
| Laryngeal Neoplasms | Laryngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External radiotherapy | Radiation | — | UNRESOLVED |
| IORT | Radiation | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- with IORT
- interventionNames
- Radiation: IORT
- Procedure: surgery
- Radiation: External radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- without IORT
- interventionNames
- Procedure: surgery
- Radiation: External radiotherapy
Primary outcomes (1)
- measure
- 2-year local recurrence rate
- timeFrame
- 2 year
- description
- In this study, no matter whether distant metastases occurred, if there was the presence of any anastomotic or lateral node recurrences, it was defined as local recurrence. Criteria for local recurrence include (1) MRI results suggests local tumor recurrence, (2)Laryngoscopy indicates local tumor recurrence.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. adults over the age of 18; 2. radiographic or pathological diagnosis of local advanced laryngocarcinoma (according to NCCN guidelines); 3. the expected survival time ≥ 3 months; 4. sign informed consent for treatment and research with self-knowledge. Exclusion Criteria: 1. there is distant metastasis; 2. pregnant women; 3. patients with CT/MRI contraindications; 4. the patient fails to receive treatment and/or follow-up as scheduled; 5. bad fluid and organ function decompensation; 6. multiple primary cancers; 7. patients participating in other trials.
References
Publications (1)
- DERIVEDYang Y, Li L, Zheng Y, Liu Q, Wei X, Gong X, Wang W, Lin P. A prospective, single-arm, phase II clinical trial of intraoperative radiotherapy using a low-energy X-ray source for local advanced Laryngocarcinoma (ILAL): a study protocol. BMC Cancer. 2020 Aug 6;20(1):734. doi: 10.1186/s12885-020-07233-1. PMID 32762662