Early Stage Glottic Squamous Cell Carcinoma Involving the Anterior Commissure
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. Glottic carcinoma with anterior commissure invasion is linked to inferior local control; both definitive radiotherapy alone or transoral laser microsurgery (TLM) may confer a higher risk of local recurrence compared with other glottic carcinomas. We hypothesize that postoperative radiotherapy can act as an effective adjunct to surgery and reduce recurrence rates in patients with glottic carcinoma involving the anterior commissure. This study aims to conduct a multicenter, prospective, single arm phase II clinical trial of intensity modulated radiotherapy (IMRT) for postoperative patients with early stage glottic laryngeal carcinoma and anterior commissure involvement, to preliminarily evaluate the effect of IMRT on local control rates and long term survival outcomes in this patient population.
Interventions
Postoperative radiotherapy clinical target volume (CTV) design: The conventional postoperative laryngeal radiotherapy target is defined as CTV1, which encompasses the entire laryngeal structure, piriform sinus, gloss-epiglottic vallecula, paraglottic space, pre-epiglottic space, thyroid cartilage, and extends to the inferior border of the cricoid cartilage. For T2 tumours, CTV2 is delineated to include bilateral cervical lymph node regions II-III. PTV1 and PTV2 are defined as the regions expanded by 3 mm outward from CTV1 and CTV2, respectively. The prescribed dose for PTV1 is 60 Gy in 30 fractions (60 Gy/30F), and the prescribed dose for PTV2 is 54 Gy in 30 fractions (54 Gy/30F).
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. Aged 18 years or older, regardless of gender; 2. Pathologically confirmed glottic squamous cell carcinoma; 3. T1-T2N0M0 glottic laryngeal carcinoma with anterior commissure involvement; 4. Patients who have undergone curative intent surgery for glottic carcinoma with negative surgical margins, within 4-8 weeks post operation; 5. No prior radiotherapy, chemotherapy or other anti neoplastic agent treatment; 6. ECOG performance status of 0 or 1; 7. Signed informed consent form.
Exclusion criteria
1. Patients without anterior commissure involvement; 2. Prior chemotherapy or treatment with other anti neoplastic agents; 3. Prior history of head and neck radiotherapy; 4. Prior participation in other clinical trials; 5. Patients with severe allergy history or allergic diathesis, e.g., contrast medium allergy; 6. Pregnant or lactating women; 7. Patients with uncontrolled acute infection; 8. Patients with drug addiction, substance abuse, chronic heavy alcohol consumption, or human immunodeficiency virus (HIV) infection; 9. Patients with other uncontrolled concurrent malignancies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year local-regional failure-free survival (LRFS) | From the date of surgery 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 surgery 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 surgery 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 surgery 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 surgery 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 surgery 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 surgery until the date of surgery due to any cause, assessed up to 5 year. | Overall Survival(OS) is defined as the period from the date of surgery to the date of death due to any cause. |
| 5-year disease-free survival (DFS) | Time from the date of surgery 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 surgery 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 surgery 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