laryngeal cancer
Conditions
Interventions
Arm A: total laryngectomy + paratracheal dissection + elective lateral neck dissection
Arm B: total laryngectomy + paratracheal dissection
Sponsors
HOMMA Akihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically proven squamous cell carcinoma from primary lesion biopsy. (2) Primary lesion exists in the larynx, and its subsite is either the glottis or the supraglottis. (3) No extension of the primary lesion to the pharynx is observed by head and neck endoscopy. In addition, if preoperative pharmacotherapy with pembrolizumab was administered, no extension to the pharynx is observed by head and neck endoscopy both before and after pharmacotherapy. (4) The patient has been diagnosed as having T3-T4aN0M0 disease by both of the following examinations (i) and (ii) (UICC-TNM 8th edition). In addition, if preoperative pharmacotherapy with pembrolizumab was administered, the patient has been diagnosed as having T3-T4aN0M0 disease by both of the following examinations (i) and (ii) before the start of pharmacotherapy. Furthermore, if either examination (i) or (ii) was performed after completion of pharmacotherapy, no cervical lymph node metastasis or distant metastasis is observed. (i) Head and neck contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) (ii) Thoracoabdominal contrast-enhanced CT, or whole-body PET (PET/CT or PET/MRI) (5) For age and Eastern Cooperative Oncology Group performance status (PS), one of the following is met. (i) Age 18-74 years with PS 0-2 (ii) Age >= 75 years with PS 0-1 (6) For patients with T3N0 disease, either of the following criteria is met. In addition, if preoperative pharmacotherapy with pembrolizumab was administered, either of the following criteria is met before the start of pharmacotherapy. (i) The patient is judged to be intolerant to high-dose cisplatin administration. (ii) Presence of vocal cord paralysis or airway stenosis resulting in impaired voice or swallowing function. (iii) Patients do not wish to receive chemoradiotherapy or radiotherapy alone. (7) No history of cervical lymph node dissection or radiotherapy to the head and neck. Diagnostic cervical lymph node biopsy is permitted. (8) No preoperative treatment other than pembrolizumab* has been administered for laryngeal cancer. However, tracheostomy for airway management is permitted. * Pembrolizumab may have been administered as preoperative pharmacotherapy up to a total dose of 400 mg. However, patients who received preoperative pharmacotherapy with pembrolizumab exceeding 400 mg are considered ineligible. (9) No dementia. (10) All of the following laboratory values are met. (i) Neutrophil count >= 1,500 /mm3 (ii) Hemoglobin >= 8.0 g/dl (iii) Platelet count >= 75,000 /mm3 (iv) Total bilirubin <= 2.0 mg/dL (v) AST <= 100 U/L (vi) ALT <= 100 U/L (vii) Serum creatinine <= 2.0 mg/dL (11) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) Simultaneous or metachronous (within three years) double cancers, with the exception of intramucosal tumor curable with local therapy. (2) Active infection requiring systemic therapy. (3) Fever over 38 degrees Celsius. (4) Female during pregnancy or lactation and those with < 28 days of postparturition period. (5) Psychological disorder or symptom difficult to participate in this clinical trial. (6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival, local relapse-free survival, proportion of subclinical cervical lymph node metastasis, proportion of head and neck relapse (overall, unresectable, and resectable), quality of life score, postoperative function (paralysis of the accessory nerve and subjective symptoms), frequency of perioperative complications, frequency of severe adverse events, frequency of pharyngocutaneous fistula, operation time, amount of blood loss, and duration of postoperative hospitalization | — |
Contacts
Public ContactAkihiro HOMMA
Hokkaido University Hospital
Outcome results
None listed