locally advanced squamous cell carcinoma of the head and neck
Conditions
Interventions
A: Preventive irradiation dose standard group (56 Gy)
CDDP (100 mg/m2, every 3 weeks, 3 times) in combination with radiation therapy.
Radiation therapy (IMRT) : SIB56 method (tumor area 70 Gy/35 Fr/7
Sponsors
Kodaira Takeshi
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 by immunohistochemical staining (IHC). (3) Comprehensively diagnosed as stage III-IVB (UICC-TNM 8th edition) by the following (except for N3a). (i) Head and neck contrast-enhanced MRI (ii) Thoracoabdominal CT (4) Aged 20 years and older. (5) ECOG Performance status 0 or 1. (6) Presence of measurable lesions is not mandatory. (7) No history of chemotherapy for any cancer, and radiation therapy for the brain and head and neck. No history of surgery for head and neck cancer. (8) Following (i) or (ii) is satisfied. (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. (9) Major organ function is preserved. (i) Neutrophil count >= 1,500 /mm3 (ii) Hemoglobin >= 9.0 mg/dl (iii) Platelet count >= 100,000 /mm3 (iv) T-bil=60 mL/min (10) 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) Female during pregnancy, within 28 days of postparturition, or during lactation. Male who wants partner's pregnancy. (5) Psychological disorder difficult to participate in this clinical study. (6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. (7) Diabetes mellitus uncontrollable with continuous use of insuline or hypoglycemic agents. (8) Uncontrolled arterial hypertension. (9) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. (10) Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy. (11) Positive for HBs antigen. (12) Positive for HIV antibody. (13) Judged that smoking cessation and abstinence are impossible during protocol treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to treatment failure 1 (starting from the registration date to the earliest of the following, the date of progression, the date of judgement of tumor remnants after the completion of protocol treatment, or the date of death due to any cause.) | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, complete response proportion, progression-free survival, loco-regional progression-free survival, time to treatment failure 2, proportion of acute adverse events, proportion of late adverse events, QOL survey (EORTC QLQ-C30, QLQ-HN43), swallowing function evaluation (swallowing endoscopy, functional outcome swallowing scale), hearing function. | — |
Contacts
Public ContactTakeshi Kodaira
Aichi Cancer Center
Outcome results
None listed