Larynx cancer
Conditions
Interventions
Definitive CRT:IMRT+concurrent cisplatin
Radiation dosage: GTV 66-70Gy/28-33F
CTV1 60-63Gy/28-33F
CTV2 50-56Gy/28-33F.
Prophylactic neck irradiation should involve at least bilateral level II-IV.
Concurrent chemotherapy: cispaltin 100mg/m2, every 3 weeks, for 3 cycles.
Evaluation at 12 weeks after
OPL ± adjuvant (chemo)radiotherapy:The surgical procedure of OPL should be SCPL-CHEP or SCPL-CHP. All patients need neck dissection for at least level II-IV.
Indications for adjuvant RT: pT4a, pN+, cl
for positive neck level, 60Gy/30F.
Chemotherapy: cisplatin 100mg/m2, every 3 weeks, for 3 cycles.
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) The pathology type of larynx cancer should be squamous cell carcinoma. (2) Glottic or supraglottic cancer; the TNM stage should be T3N0-3M0 (according to the 8th AJCC staging system). (3) Evaluated by the otolaryngologist-head and neck surgeon, the tumor is unsuitable for transoral microsurgery, but suitable for open partial laryngectomy, and the surgical procedure is supracricoid partial laryngectomy (SCPL) with either cricohyoidoepiglottopexy (CHEP) or cricohyoidopexy (CHP). (4) Patients have no contraindications for radiotherapy and cisplatin. (5) Karnofsky performance scale (KPS) = 80. (6) Normal bone marrow function: WBC=4×109/L, hemoglobin=90g/L, Platelet=100×109/L. (7) Normal liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) =1.5×upper limit of normal (ULN); alkaline phosphatase (ALP) =2.5×ULN; bilirubin=ULN. (8) Normal kidney function: creatinine clearance =60 ml/min. (9) Normal pulmonary function: FEV1=60%. No pneumonia history within the past three months. (10) Patients must be told about the content of this trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients can not stand surgery. (2) Patients can not stand radiotherapy or cisplatin. (3) Age>70 or < 18 years old. (4) Treatment is palliative. (5) With other primary malignant tumors at the same time. (6) Prior malignant tumor history, except for cured skin cancer (basaloid squamous cell carcinoma or squamous cell carcinoma) and cervical carcinoma in situ. (7) Pregnant or breastfeeding women (women of childbearing potential should have pregnancy tests; patients of childbearing/reproductive potential should agree to use adequate birth control measures). (8) Radiotherapy history (except for non-melanoma skin cancer outside the head and neck region). (9) Already received treatment for primary or neck disease (except for the diagnostic treatment). (10) Severe comorbidity that may pose an unacceptable risk or undermine treatment compliance. For example: unstable heart disease, kidney disease, chronic hepatitis which need treatment, uncontrolled diabetes and mental diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| laryngo-esophageal dysfunction-free survival, LEDFS (3 year); | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, OS;disease-free survival, DFS;laryngectomy-free survival, LFS;locoregional control,LRC;Acute toxicity related to (chemo)radiotherapy;Surgical complications within 30 days;Late toxicity related to (chemo)radiotherapy;Quality of life;Quality of voice;Swallow function; | — |
Countries
China
Contacts
Public ContactWen-Bin Lei
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed