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

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ClinicalTrials.gov Identifier: NCT02765503
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : March 30, 2017
Sponsor:
Collaborators:
Centro de Lucha contra el Cáncer, Montevideo, Uruguay
Institute Rotary Cancer Hospital, New Delhi, India
Tata Memorial Centre
Bahawalpur Institute of Nuclear Medicine and Oncology, Bahawalpur, Pakistan
GKNM Hospital, Tamil Nadu, India
Fundacion Escuela de Medicina Nuclear, Mendoza, Argentina
Instituto de Oncología y Radiobiología, Havana, Cuba
University of Indonesia, Jakarta, Indonesia
St Luke's Medical Centre, Quezon City, Manilla, Phillippines
University of Pretoria, Pretoria, South Africa
Mahidol University, Bangkok, Thailand
University of Maryland
Information provided by (Responsible Party):
International Atomic Energy Agency

Brief Summary:
The aim of the study is to test whether a resource-sparing 4-week, 20-fraction course of accelerated hypofractionated radiotherapy is non-inferior to accelerated radiotherapy delivering 33 fractions over 5.5 weeks in the treatment of patients with Stage I-IV squamous cell carcinoma of the pharynx, larynx and oral cavity with the exception of paranasal sinus, nasopharyngeal and stage I-II glottic carcinomas.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Radiation: External beam radiotherapy Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 836 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Trial of Accelerated Hypo - vs. Normo-fractionated Radiotherapy for Head and Neck Squamous Cell Carcinoma (IAEA-HYPNO Trial)
Study Start Date : March 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
'Standard' external beam radiotherapy to deliver 66Gy in 33 fractions treating with 6 fractions a week.
Radiation: External beam radiotherapy
External beam radiotherapy using megavoltage radiotherapy with radical intent.
Other Name: Radical radiotherapy

Experimental: HYPNO
The experimental regimen in which patients receive external beam radiotherapy to deliver 55Gy in 20 fractions treating 5 times a week.
Radiation: External beam radiotherapy
External beam radiotherapy using megavoltage radiotherapy with radical intent.
Other Name: Radical radiotherapy




Primary Outcome Measures :
  1. Primary tumor control in T and N position [ Time Frame: 3 years after date of randomisation in HYPNO ]
  2. Treatment related late Grade 2+ toxicity (CTCAE 4.0) [ Time Frame: 3 years after date of randomisation in HYPNO ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1, 3 and 5 years after date of randomisation in HYPNO ]
  2. Disease free survival [ Time Frame: 1, 3 and 5 years after date of randomisation in HYPNO ]
  3. Any other treatment related early and late morbidities (CTCAE 4.0) [ Time Frame: 1 and 3 years after date of randomisation in HYPNO ]
  4. EORTC QOL-C30/HN-35 (optional) [ Time Frame: 1 and 3 years after date of randomisation in HYPNO ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765503


Contacts
Contact: Kirsten I Hopkins, MD FRCP FRCR +431260022401 k.hopkins@iaea.org
Contact: Oleg Belyakov, PhD +431260021667 O.Belyakov@iaea.org

Locations
Argentina
Fundacion Escuela de Medicina Nuclear Recruiting
Mendoza, Argentina, 5500
Contact: Sergio Binia       S.Binia-Alvarez@iaea.org   
Cuba
Instituto Naciolal de Oncologia y Radiobiologia (INOR) Recruiting
Havana, Cuba, 10400
Contact: Misleidy M. NAPOLES MORALES, MD         
Contact       misleidy.napoles@infomed.sld.cu   
India
Department of Radiation Oncology, V.N. Cancer Center, GKNM Hospital Recruiting
Coimbatore, India, Tamil Nadu 641 037
Contact: Nagarajan Murugaiyan    +9104222216715    mnr81@yahoo.com   
Tata Memorial Centre (TMC) Department of Atomic Energy (DAE) Recruiting
Mumbai, India
Contact: Tejpal Gupta       tejpalgupta@rediffmail.com   
Institute Rotary Cancer Hospital Recruiting
New Delhi, India
Contact: Suman BHASKER       drsumanbhasker@gmail.com   
Indonesia
Cipto Magunkusumo General Hospital, University of Indonesia Recruiting
Jakarta, Indonesia, 10430
Contact: Sochartati Gondhowiardjo       gondhow@gmail.com   
Pakistan
Bahawalpur Institute of Nuclear Medicine and Oncology (BINO) Recruiting
Bahawalpur, Pakistan
Contact: Kaukab JABEEN       kaukab1986@hotmail.com   
Philippines
St Luke's Medical Centre, Quezon City Recruiting
Manilla, Philippines
Contact: Miriam Calaguas       miriamcalaguas@yahoo.com   
South Africa
University of Pretoria Recruiting
Pretoria, South Africa
Contact: Roy Lakier       roy.lakier@up.ac.za   
Thailand
Mahidol University Faculty of Medicine Siriraj Hospital Recruiting
Bangkok, Siriraj, Thailand, 10700
Contact: Yaowalak Chansilp       yaowalak.ch@hotmail.com   
Uruguay
Centro de Lucha contra el Cáncer Recruiting
Montevideo, Uruguay
Contact: Sergio AGUIAR VITACCA       saguiar@adinet.com.uy   
Contact: A         
Sponsors and Collaborators
International Atomic Energy Agency
Centro de Lucha contra el Cáncer, Montevideo, Uruguay
Institute Rotary Cancer Hospital, New Delhi, India
Tata Memorial Centre
Bahawalpur Institute of Nuclear Medicine and Oncology, Bahawalpur, Pakistan
GKNM Hospital, Tamil Nadu, India
Fundacion Escuela de Medicina Nuclear, Mendoza, Argentina
Instituto de Oncología y Radiobiología, Havana, Cuba
University of Indonesia, Jakarta, Indonesia
St Luke's Medical Centre, Quezon City, Manilla, Phillippines
University of Pretoria, Pretoria, South Africa
Mahidol University, Bangkok, Thailand
University of Maryland
Investigators
Principal Investigator: Soren Bentzen University of Maryland

Responsible Party: International Atomic Energy Agency
ClinicalTrials.gov Identifier: NCT02765503     History of Changes
Other Study ID Numbers: E33035
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site