head and neck squamous cell carcinoma
Conditions
Interventions
Arm A: Radiotherapy (RT) alone
* RT: 2 Gy per fraction, once daily, 5 days per week, for a total of 35 fractions (total dose: 70 Gy), delivered by IMRT using SIB56 method.
Arm B: Concurrent chemoradio
Sponsors
KANEMITSU Yukihide
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Primary lesion exists in the oropharynx, hypopharynx, or larynx. (2) Histologically proven squamous cell carcinoma from primary leision biopsy. In case of oropharyngeal cancer, p16 is negative or positive by immunohistochemical staining. (3) Diagnosed as stage III-IVB for p16-negative oropharyngeal, hypopharyngeal, or laryngeal cancer, and as stage II (T1-3N2M0) or stage III for p16-positive oropharyngeal cancer (UICC-TNM 8th edition), by the following examinations. (i) Head and neck contrast-enhanced CT or MRI (ii) Thoracoabdominal CT (4) Aged 70 years and older. (5) ECOG Performance status (PS) 0-2. (6) For age, PS, renal function, and comorbidities, any of the following (i)-(vi) are met. * Comorbidity A: cardiovascular disease, diabetes mellitus, liver cirrhosis, cerebrovascular disease, chronic pulmonary disease, hearing impaired. (i) All of the following (a)-(d) are met. (a) age 70-74 years, (b) PS 0-1, (c) eGFR >= 60 mL/min/1.73 m2, (d) at least one comorbidity A present (ii) All of the following (a)-(c) are met. (a) age 70-74 years, (b) PS 0-1, (c) eGFR 50-= 50 mL/min/1.73 m2, (d) no comorbidity A (iv) All of the following (a)-(d) are met. (a) age >= 75 years, (b) PS 0, (c) eGFR >= 80 mL/min/1.73 m2, (d) at least one comorbidity A present (v) All of the following (a)-(c) are met. (a) age >= 75 years, (b) PS 0, (c) eGFR 50-= 75 years, (b) PS 1, (c) eGFR >= 50 mL/min/1.73 m2 (7) Presence of measurable lesions is not mandatory. (8) All of the following criteria (i)-(iv) are met. (i) No history of treatment with CDDP for any cancer. (ii) No history of radiation therapy for the brain and head and neck. (iii) No history of surgery for cancers with a primary site in the oropharynx, hypopharynx, or larynx. (iv) No history of neck lymph node dissection for malignant tumors. (9) Any of the following criteria are met. (i) Judged that technically and functionally radical surgical resection is impossible by consulting with head and neck surgeon or otolaryngologist. (ii) Patients do not have a preference to receive a surgical resection, even though the surgeon judged surgical resection is possible. (10) No dementia, or dementia with family support to continue protocol treatment or examinations. (11) All of the following laboratory values are met. (i) Neutrophil count >= 1,500 /mm3 (ii) Hemoglobin >= 9.0 g/dl (iii) Platelet count >= 100,000 /mm3 (iv) T-bil = 50 mL/min/1.73 m2. (13) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) Simultaneous or metachronous (within 3 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) Psychological disorder difficult to participate in this clinical study. (5) Receiving continuous systemic corticosteroid or immunosuppressant treatment. (6) Uncontrolled arterial hypertension. (7) History of unstable angina pectoris within three weeks or myocardial infarction within twelve months before registration. (8) NYHA functional class II or higher, or EF = 8.0%. (10) Clinically diagnosed liver cirrhosis classified as Child-Pugh class B or C. (11) History of cerebrovascular disease within the past 12 months, or with residual deficits impairing activities of daily living or social functioning if occurred earlier. (12) Chronic pulmonary disease (interstitial pneumonia, pulmonary fibrosis, or severe emphysema, alone or in combination) with COPD classified as stage III or higher. (13) Hearing impaired of Grade >= 3, as defined by CTCAE v5.0 (Adults not enrolled on a Monitoring Program). (14) Positive for HBs antigen or HCV antibody. (15) Positive for HIV antibody. (16) Judged that smoking cessation and abstinence are impossible during protocol treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, time-to-treatment-failure 1, time-to-treatment-failure 2, loco-regional progression-free survival, complete response proportion, cumulative incidence of loco-regional progression, cumulative incidence of distant metastasis, cumulative incidence of disease-specific death, cumulative incidence of death from other causes, proportion of adverse events, proportion of serious adverse events, dose intensity of cisplatin, proportion of protocol treatment completion, QOL survey, proportion of patients without IADL deterioration | — |
Contacts
Public ContactHiroshi KATAYAMA
National Cancer Center Hospital
Outcome results
None listed