Clinical trial · Interventional
Role of Radiotherapy in T1-T2N0M0 Glottic Carcinoma With Poor Differentiation
Role of Radiotherapy in T1-T2N0M0 Glottic Carcinoma With Poor Differentiation: A Prospective Multicenter Phase II Clinical Trial
- 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)
There remains no uniform treatment modality for glottic laryngeal carcinoma. Current clinical guidelines broadly recommend surgery or radiotherapy as single-modality treatment for early-stage glottic laryngeal carcinoma. Surgery is the predominant treatment modality for patients with early-stage glottic carcinoma in China. Patients with poorly-differentiated early-stage glottic carcinoma exhibit inferior local control after surgery compared with those with moderately-to-well-differentiated tumours. Data from our previous retrospective study suggest that definitive radiotherapy/postoperative radiotherapy yields superior local control compared with surgery alone for poorly-differentiated early-stage glottic carcinoma. We hypothesize that definitive radiotherapy and postoperative radiotherapy can improve local control rates in patients with poorly-differentiated early-stage glottic squamous cell carcinoma. This study aims to conduct a multicenter, prospective, single-arm phase II clinical trial using intensity-modulated radiotherapy (IMRT) for patients with poorly-differentiated early-stage glottic laryngeal carcinoma, to preliminarily evaluate the impact of IMRT on local control rates and long-term survival outcomes in this patient population.
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 |
|---|---|---|---|
| Early Stage Glottic Squamous Cell Carcinoma With Poor Differentiation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation: intensity modulated radiotherapy (IMRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy
- description
- intensity modulated radiotherapy (IMRT)
- interventionNames
- Radiation: Radiation: intensity modulated radiotherapy (IMRT)
Primary outcomes (1)
- measure
- 3-year local-regional failure-free survival (LRFS)
- timeFrame
- From the date of enrollment to the date of local recurrence, , assessed up to 3 year.
- description
- 3-year local-regional failure-free survival (LRFS): defined as the time from the date of enrollment to recurrence of the primary lesion and perilesional tissues. The index date for recurrence is the date when a measurable new lesion is first identified. For patients who die of any other cause prior to documented disease recurrence, LRFS is calculated from the date of enrollment to the date of death. For patients without documented disease recurrence or death at the time of analysis (i.e., recurrence-free survivors), the time of the last efficacy assessment will be used as the endpoint.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years, any gender 2. Histologically proven glottic squamous cell carcinoma 3. T1 T2N0M0 glottic laryngeal carcinoma with poor differentiation (moderate poor differentiation counted as poor differentiation) 4. Subjects undergoing curative intent surgery must be enrolled 4 8 weeks after operation. 5. No prior chemoradiotherapy or antineoplastic therapy 6. ECOG PS 0 1 7. Written informed consent provided Exclusion Criteria: 1. Moderately or well differentiated tumours 2. Prior chemotherapy or other antineoplastic agents 3. Prior head and neck irradiation 4. Previous participation in another clinical trial 5. Severe allergic history including contrast media allergy 6. Pregnancy or lactation 7. Uncontrolled acute infection 8. Drug/substance abuse, chronic heavy drinking, HIV infection 9. Uncontrolled concomitant malignant disease
References
Publications (0)
Data not yet available