Early Stage Glottic Squamous Cell Carcinoma With Poor Differentiation
Conditions
Brief summary
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.
Interventions
RADIATIONRadiation: intensity modulated radiotherapy (IMRT)
Post operative radiotherapy (CTV): CTV1 is routine postoperative laryngeal target covering whole larynx, piriform sinus, glosso epiglottic vallecula, paraglottic space, pre epiglottic space, thyroid cartilage down to inferior border of cricoid cartilage. Given higher lymphatic metastatic risk of poorly differentiated tumours, CTV2 delineates bilateral cervical nodal levels II III. PTV1/PTV2 are 3 mm isotropic expansions of CTV1/CTV2. Prescription: PTV1 60 Gy/30 fractions; PTV2 54 Gy/30 fractions. Definitive radiotherapy targets: Additional GTV denotes macroscopic tumour identified by laryngoscopy and imaging. PGTV/PTV1/PTV2 are 3 mm isotropic expansions of GTV/CTV1/CTV2. Prescription: PGTV 66 Gy/30 fractions; PTV1 60 Gy/30 fractions; PTV2 54 Gy/30 fractions.
Sponsors
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year local-regional failure-free survival (LRFS) | From the date of enrollment to the date of local recurrence, , assessed up to 3 year. | 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
| Measure | Time frame | Description |
|---|---|---|
| 5-year local-regional failure-free survival (LRFS) | From the date of enrollment to the date of local recurrence, assessed up to 5 year. | 5-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. |
| 5-year overall survival (OS) | From the date of enrollment until the date of death due to any cause, assessed up to 5 year. | Overall Survival(OS) is defined as the period from the date of enrollment to the date of death due to any cause. |
| 5-year disease-free survival (DFS) | Time from the date of enrollment to any evidence of tumour growth or death, assessed up to 5 year. | 5-year disease-free survival (DFS): defined as the time from the date of enrollment during which the patient remains alive without evidence of tumour growth. Recurrence is defined as the emergence of new lesions, including recurrence of the primary lesion and perilesional tissues, cervical lymph-node metastasis, and distant metastasis. The index date for recurrence is the date on which a measurable new lesion is first identified. For patients who die of any other cause prior to documented disease recurrence, DFS is calculated from the date of enrollment to the date of death. For patients with no documented disease recurrence or death at the time of analysis (i.e., disease-free survivors), the time of the last efficacy assessment will serve as the endpoint. |
| Adverse events | From enrollment to the end of treatment at 5 years. | The incidence, type, and severity of adverse events (AEs), serious AEs, and immune-related AEs (irAEs) were assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0). |
Countries
China
Contacts
CONTACTDongjun Dai, Doctor
Outcome results
None listed