Oropharyngeal, hypopharyngeal or laryngeal cancer oropharynx, hypopharynx, larynx, cancer, radiotherapy
Conditions
Interventions
Short-term radiotherapy of 55 Gy/20 fractions, with a intratumoral high dose boost of 66 Gy/20 fractions. At least one replan is performed during treatment to adapt to changes of the tumour volume (ad
D011878, D002945
Radiotherapy, Cisplatin
Sponsors
Yasuda Koichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Primary site in the oropharynx, hypopharynx, or larynx. 2) Histologically diagnosed as squamous cell carcinoma (In the case of oropharyngeal carcinoma, p16-negative by immunohistochemical staining). 3) The patient has been diagnosed in stages III to IVB (UICC-TNM 8th edition) based on the examinations in i) and ii). i) Contrast-enhanced CT or MRI of the head and neck (if contrast media is not tolerated due to allergy, renal dysfunction, or bronchial asthma, or if the patient refuses to use it, non-contrast MRI can be used instead, but not non-contrast CT). The investigator may decide whether to use CT or MRI, but the same imaging modality must be used for treatment response evaluation and follow-up. ii) Either a) or b) below a) Contrast-enhanced CT of the chest and abdomen (if contrast media is not tolerated due to allergy, renal impairment, or bronchial asthma, or if the patient refuses to use contrast media, a non-contrast CT scan is acceptable) b) PET-CT (contrast or non-contrast) and breath-hold chest CT (contrast or non-contrast, from the apex of the lung to the base of the lung) 4) Age 20 years or older on the date of informed consent. 5) Performance status (PS) 0 or 1 (ECOG criteria) 6) No history of chemotherapy, including treatment for other types of cancer, no history of radiation therapy for the brain and head and neck region, and no history of radical surgical resection for head and neck cancer (Neck lymph node biopsy for diagnostic purposes is not excluded). 7) Not indicated for radical surgery, or the patient does not accept the surgery. 8) The latest blood test results taken within 14 days of registration must meet all of the following criteria. 1. Neutrophil count above 1,500/mm3 2. Haemoglobin above 9.0 g/dL 3. Platelet count above 10 x 10^4/mm3 4. Total bilirubin below 2.0 mg/dL 5. AST below 100 U/L 6. ALT below 100 U/L 7. eGFR above 60 mL/min/1.73m2 eGFR (Japanese Society of Nephrology) formula Male: 194 x [serum creatinine level (mg/dL)]^(-1.094) x (age)^(-0.287) Female: 194 x [serum creatinine level (mg/dL)]^(-1.094) x (age)^(-0.287) x 0.739 9) Consent to participate in the study has been obtained in written form.
Exclusion criteria
Exclusion criteria: (1) Patients with active multiple cancers (Multiple cancers and synchronous multiple cancers with a disease-free period of less than 3 years. Lesions diagnosed as having in situ or mucosal cancer of the esophagus, stomach or large intestine based on endoscopic findings before registration are not included in the category of active multiple cancers. Even if the disease-free period is less than three years, cancers with a 5-year relative survival rate of 95% or more, such as clinical stage I prostate cancer, clinical stage 0 or I laryngeal cancer that has completely responded to radiotherapy, and the following cancers that have been completely resected, are not included in the category of active multiple cancers. Stomach cancer (adenocarcinoma (general type)): stage 0-I, colon cancer (adenocarcinoma): stage 0-I, rectal cancer (adenocarcinoma): stage 0-I, esophageal cancer (squamous cell carcinoma, adenosquamous cell carcinoma, basaloid carcinoma): stage 0, breast cancer (non-invasive ductal carcinoma, non-invasive lobular carcinoma): stage 0, breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, Paget's disease): stage 0-IIA, uterine cancer (endometrioid adenocarcinoma, mucinous adenocarcinoma): stage I, prostate cancer (adenocarcinoma): stage I-II, cervical cancer (squamous cell carcinoma): stage 0, thyroid cancer (papillary carcinoma, follicular carcinoma): stages I, II, III, kidney cancer (clear cell carcinoma, chromophobe cell carcinoma): stage I, other carcinoma in situ (UICC 8th). 2) Have an infectious disease that requires systemic treatment. 3) Have a fever of 38.0 degrees celsius or higher at the time of registration. 4) Are a woman who is pregnant, possibly pregnant, within 28 days of child birth, or breastfeeding. Are a man whose partner wants to become pregnant. 5) Have a mental disorder or mental symptoms that interfere with daily life and are judged to be difficult to participate in the study. 6) Receiving continuous systemic administration (oral or intravenous) of steroid or other immunosuppressive drugs. 7) Having poorly controlled diabetes with HbA1c of 8.0% or higher. 8) Having poorly controlled hypertension with systolic blood pressure of 180 mmHg or higher. 9) Has unstable angina (angina that has developed or worsened within the last 3 weeks) or has a history of myocardial infarction within the last 6 months. 10) Has poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. 11) Is judged to be unable to stop smoking or drinking during the study treatment. 12) Is judged by the principal investigator or other investigators to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation: Dose Limiting Toxicity (DLT) (the proportion of Grade 4 or higher adverse events from the start of treatment to 90 days later) Efficacy validation: Overall survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation: Incidence of adverse events (Key secondary endpoint: Grade 3 or 4 dysphagia at 1 year after treatment initiation) Efficacy validation: Incidence of adverse events, complete response rate, locoregional progression-free survival, progression-free survival, laryngeal function preservation rate, QOL score. | — |
Contacts
Public ContactKoichi Yasuda
Department of Radiation Oncology, Hokkaido University Hospital
Outcome results
None listed