JCOG1912: Novel approach of prophylactic radiation to reduce toxicities comparing 2-step-40 with SIB-56 IMRT techniques for locally advanced squamous cell carcinoma of the head and neck, an intergroup phase III trial. - NEW BRIDGE

Kodaira Takeshi0 个研究点目标入组 400 人开始时间: 2021年5月18日最近更新: 2023年10月17日

试验速览

暂无简介。

•(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<=2.0 mg/dL
•(v) AST =< 100 U/L
•(vi) ALT =< 100 U/L
•(vii) Ccr>=60 mL/min
•(10) Written informed consent.

•(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.

发起方

Kodaira Takeshi