Resource Sparing Curative Radiotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck: The HYPNO Trial (HYPNO)
Squamous Cell Carcinoma of the Head and Neck
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck
Eligibility Criteria
Inclusion Criteria:
- Tumor classified as stage I-IV located in oropharynx, hypopharynx, larynx (not glottic stage I-II), or oral cavity according to the TNM classification
- Histopathological diagnosis of invasive squamous cell carcinoma at the primary site
- Age > 18 years
- Informed consent according to the Helsinki declaration and local regulations
- The patient must be a candidate for external beam radical radiotherapy, and must be expected to complete the treatment
- WHO performance status of 0-2
- For patients receiving concomitant chemotherapy: Normal CBC and normal function of liver and kidney by routine laboratory examinations.
Impaired function of liver is defined as elevation of liver enzymes by 2.5 times the upper limit of the normal reference value for the institution and of kidney as serum creatinine by 1.5 times the upper limit of the normal reference value for the institution by routine laboratory examinations or creatinine clearance level less than 50 ml/min
Exclusion Criteria
- Distant metastases
- The patient should not be in a state or have major co-morbidity that could be expected to influence the outcome of treatment, or interfere with the assessment of treatment outcome at follow-up, or (apart from the present disease) considerably reduce the life expectancy
- Patients who test positive for human immunodeficiency virus (HIV)
- Prior surgical excision (except biopsy)
- Planned (elective) surgery
- The existence of synchronous multiple malignancies (not leukoplakia) or previous history of cancer
- The patient must not be pregnant
- Socio-demographic or other factors that make it unlikely that the patient will be available for follow up of long term treatment outcome
3.5. Additional criterion for patients receiving chemotherapy
Sites / Locations
- Fundacion Escuela de Medicina NuclearRecruiting
- Instituto Naciolal de Oncologia y Radiobiologia (INOR)Recruiting
- Department of Radiation Oncology, V.N. Cancer Center, GKNM HospitalRecruiting
- Tata Memorial Centre (TMC) Department of Atomic Energy (DAE)Recruiting
- Institute Rotary Cancer HospitalRecruiting
- Cipto Magunkusumo General Hospital, University of IndonesiaRecruiting
- Bahawalpur Institute of Nuclear Medicine and Oncology (BINO)Recruiting
- St Luke's Medical Centre, Quezon CityRecruiting
- University of PretoriaRecruiting
- Mahidol University Faculty of Medicine Siriraj HospitalRecruiting
- Centro de Lucha contra el CáncerRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control
HYPNO
'Standard' external beam radiotherapy to deliver 66Gy in 33 fractions treating with 6 fractions a week.
The experimental regimen in which patients receive external beam radiotherapy to deliver 55Gy in 20 fractions treating 5 times a week.