Resource Sparing Curative Radiotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck: The HYPNO Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02765503
• Date of registration: 29/04/2016
• Prospective Registration: No
• Primary sponsor: International Atomic Energy Agency
• Public title: Resource Sparing Curative Radiotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck: The HYPNO Trial HYPNO
• Scientific title: A Randomized Multicenter Trial of Accelerated Hypo - vs. Normo-fractionated Radiotherapy for Head and Neck Squamous Cell Carcinoma (IAEA-HYPNO Trial)
• Date of first enrolment: March 2014
• Target sample size: 836
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02765503
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Argentina, Cuba, India, Indonesia, Pakistan, Philippines, South Africa, Thailand, Uruguay

Contacts

• Name: Kirsten I Hopkins, MD FRCP FRCR

• Name: Soren Bentzen
• Affiliation: University of Maryland, College Park

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Tumor classified as stage I-IV located in oropharynx, hypopharynx, larynx (not glottic
stage I-II), or oral cavity according to the TNM classification

2. Histopathological diagnosis of invasive squamous cell carcinoma at the primary site

3. Age > 18 years

4. Informed consent according to the Helsinki declaration and local regulations

5. The patient must be a candidate for external beam radical radiotherapy, and must be
expected to complete the treatment

6. WHO performance status of 0-2

7. 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

1. Distant metastases

2. 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

3. Patients who test positive for human immunodeficiency virus (HIV)

4. Prior surgical excision (except biopsy)

5. Planned (elective) surgery

6. The existence of synchronous multiple malignancies (not leukoplakia) or previous
history of cancer

7. The patient must not be pregnant

8. 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Squamous Cell Carcinoma of the Head and Neck

Intervention(s)

Radiation: External beam radiotherapy

Primary Outcome(s)

Treatment related late Grade 2+ toxicity (CTCAE 4.0) [Time Frame: 3 years after date of randomisation in HYPNO]

Primary tumor control in T and N position [Time Frame: 3 years after date of randomisation in HYPNO]

Secondary Outcome(s)

Disease free survival [Time Frame: 1, 3 and 5 years after date of randomisation in HYPNO]

Overall survival [Time Frame: 1, 3 and 5 years after date of randomisation in HYPNO]

Any other treatment related early and late morbidities (CTCAE 4.0) [Time Frame: 1 and 3 years after date of randomisation in HYPNO]

EORTC QOL-C30/HN-35 (optional) [Time Frame: 1 and 3 years after date of randomisation in HYPNO]

Secondary ID(s)

E33035

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Pretoria, Pretoria, South Africa

University of Indonesia, Jakarta, Indonesia

Barretos Cancer Hospital, Barretos, Brazil

Institute Rotary Cancer Hospital, New Delhi, India

Bahawalpur Institute of Nuclear Medicine and Oncology, Bahawalpur, Pakistan

Centro de Lucha contra el Cáncer, Montevideo, Uruguay

Instituto de Oncología y Radiobiología, Havana, Cuba

Tata Memorial Centre

Mahidol University, Bangkok, Thailand

St Luke's Medical Centre, Quezon City, Manilla, Phillippines

University of Maryland, College Park

Fundacion Escuela de Medicina Nuclear, Mendoza, Argentina

GKNM Hospital, Tamil Nadu, India