clinical stage I/II (T1-2N0) tongue cancer
Conditions
Interventions
A: partial glossectomy with prophylactic neck dissection
B: partial glossectomy alone
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proven squamous cell carcinoma by biopsy specimen of the tongue 2)Clinically diagnosed as Stage I/II (T1-2, N0, M0) tongue carcinoma (UICC-TNM 8th edition) i)The maximum of tumor diameter is 4 cm or less by enhanced computed tomography and clinical findings. ii)No lymph node metastases by enhanced computed tomography of neck iii)No distant metastases by enhanced computed tomography of chest and upper abdomen 3)DOI of tumor spread from 3 mm to 10 mm by enhanced magnetic resonance imaging 4)Age >= 20 and =< 80 5)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6)No history of tongue carcinoma 7)No previous cervical lymph node resection or radiotherapy to the neck 8)No preoperative therapy for tongue carcinoma 9)No previous chemotherapy or radiotherapy for any malignant neoplasms. 10)Adequate organ and marrow function as defined below within 28 days prior to registration:a) White blood cell >= 3,000 /mm3 b) Hemoglobin >= 8.0 g/dL c) Platelets >= 75,000 /mm3 d) Total bilirubin =< 2.0 mg/dL e) AST=< 100 IU/L f) ALT=< 100 IU/L g) Creatinine =< 1.5 mg/dL 11)No abnormal findings requiring treatment on electrocardiogram (ECG) within 28 days prior to registration 12)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers. 2)Active infection requiring systemic therapy 3)Body temperature >= 38 degrees Celsius 4)Women during pregnancy, within 28 days of postparturition, or during lactation. Men favoring gestation of their partners. 5)Severe psychiatric disease 6)Patients requiring systemic steroid medication or the other immunosuppressive drug excluding corticosteroid drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival, Local-relapse-free survival, Proportion of unresectable relapse, Proportion of cervical-lymph node relapse, Postoperative function (paralysis of the accessory nerve and the mandibular branch of the facial nerve, subjective symptoms), Adverse events | — |
Countries
Japan
Contacts
Public ContactNobuhiro Hanai, MD, PhD
JCOG1601 Coordinating Office Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Japan
Outcome results
None listed