Advanced head and neck squamous cell carcinoma
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients scheduled for 3D-CRT or IMRT palliative fractionated radiotherapy (QUAD Shot; 14-14.8 Gy/4 fractions/2 days/cycle; 3-6 weeks interval; totally 3 cycles) for advanced head and neck squamous cell carcinoma (Stage III or IV on UICC 8th). 2) Patients who are not indicated for radical radiotherapy (conventionally fractionated irradiation with 60Gy or more). For example, patients who have refused radical radiotherapy or in whom radical radiotherapy is not feasible due to advanced lesions, old age, or complications. Patients who cannot tolerate conventionally fractionated irradiation under long-term hospitalization management due to complications such as delirium are also included in the criteria. 3) Patients aged 20 and older. 4) Patients pathologically diagnosed with squamous carcinoma of the head and neck region with lesions that can be assessed on imaging modalities. 5) Patients with ECOG performance status (PS) 0 to 3. 6) Patients who are fully informed prior to participating in this study, and voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with previous radiotherapy on regions that overlap with the irradiated volume. 2) Women who are pregnant, breastfeeding or may be pregnant. 3) Patients whom the attending physician deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate for three cycles. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response assessment based on imaging findings and physical examinations, overall survival, progression-free survival, QOL score, adverse events, additional treatment. | — |
Countries
Japan
Contacts
Nagasaki University Radiological Sciences