Residual lesion or local recurrence after radiotherapy for head and neck cancer
Conditions
Interventions
Transoral surgery for residual lesion or local recurrence after radiotherapy for head and neck cancer
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients have received radical irradiation (radiation dose of 60 Gy or more) for the primary disease in the past. 2) Histologically diagnosed as squamous cell carcinoma (not including severe dysplasia). 3) Clinically diagnosed as residual lesion or local recurrence. 4) Most of the lesion is confined to the epithelium and subepithelial layer. 5) Lesions primarily located in the oropharynx, hypopharynx or supraglottic (not including cervical esophageal lesions). 6) A clinical diagnosis that the residual lesion or local recurrence is 4cm or less in diameter (rT2) (T factor before radical irradiation is not considered). 7) Neither CT nor MRI shows obvious cartilage invasion of the residual lesion or local recurrence. 8) No evidence of lymph node metastasis or distant metastasis on computed tomography of the neck, chest or abdomen (rN0M0) (Regions including the cranial base should be scanned, with a slice thickness of 10 mm or less.) 9) An age of 20 years to 75 years or younger at the time of registration. 10) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 11) All of the following conditions are met (all laboratory tests should be the most recent within 28 days prior to enrollment) Testing on the same day of the week 4 weeks prior to registration is acceptable) a. Leukocyte count >= 3000/uL b. Hemoglobin level >= 10 g/dL c. Platelet count >=100 x 103/uL d. Aspartate aminotransferase and alanine transaminase levels 3 times or less the institutional upper limit of normal e. Total bilirubin levels 1.5 times or less the institutional upper limit of normal f. No electrocardiographic abnormalities requiring treatment on 12-lead electrocardiograms obtained at rest 12) Written consent to participate in the study has been obtained.
Exclusion criteria
Exclusion criteria: 1) Patient has two or more multiple cancers of the head and neck region other than the primary lesion at the time of enrollment. 2) Incurable multiple head and neck cancers or double cancers 3) Scheduled to receive chemotherapy (including endocrine therapy, molecular targeted therapy, or immune checkpoint inhibitors) for multiple head and neck cancers or double cancers at the time of enrollment. 4) Women who might be pregnant 5) Participation in the study is precluded by the presence of psychosis or psychiatric symptoms. 6) Active infection (a fever of >=38 degrees and bacterial infection confirmed on imaging studies or bacteriologic examinations) 7) Investigator determines that the patient is ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year relapse-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| En bloc resection rate The rate of adverse events associated with transoral surgery 2 and 5-year Overall survival rates, Relapse-free survival rates, Cause-specific survival rates, Laryngeal preservation survival rates and Laryngeal function preservation rates. Local recurrence rate Lymph node and distant recurrence rate Examinations of voice, swallowing function, and pain Comparison with data of the National registration survey of superficial head and neck cancer and TOS-J trial. | — |
Countries
Japan
Contacts
Public ContactKoichi Kano
Kitasato University School of Medicine Department of Otorhinolaryngology - Head and Neck Sugery
Outcome results
None listed