NCT02765503

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.

Trial Health

50
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
836

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
9 countries

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

6.7 years

First QC Date

April 29, 2016

Last Update Submit

August 6, 2019

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (2)

  • Primary tumor control in T and N position

    3 years after date of randomisation in HYPNO

  • Treatment related late Grade 2+ toxicity (CTCAE 4.0)

    3 years after date of randomisation in HYPNO

Secondary Outcomes (4)

  • Overall survival

    1, 3 and 5 years after date of randomisation in HYPNO

  • Disease free survival

    1, 3 and 5 years after date of randomisation in HYPNO

  • Any other treatment related early and late morbidities (CTCAE 4.0)

    1 and 3 years after date of randomisation in HYPNO

  • EORTC QOL-C30/HN-35 (optional)

    1 and 3 years after date of randomisation in HYPNO

Study Arms (2)

Control

ACTIVE COMPARATOR

'Standard' external beam radiotherapy to deliver 66Gy in 33 fractions treating with 6 fractions a week.

Radiation: External beam radiotherapy

HYPNO

EXPERIMENTAL

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

Interventions

External beam radiotherapyRADIATION

External beam radiotherapy using megavoltage radiotherapy with radical intent.

Also known as: Radical radiotherapy
ControlHYPNO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Additional criterion for patients receiving chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Fundacion Escuela de Medicina Nuclear

Mendoza, 5500, Argentina

RECRUITING

Instituto Naciolal de Oncologia y Radiobiologia (INOR)

Havana, 10400, Cuba

RECRUITING

Department of Radiation Oncology, V.N. Cancer Center, GKNM Hospital

Coimbatore, Tamil Nadu 641 037, India

RECRUITING

Tata Memorial Centre (TMC) Department of Atomic Energy (DAE)

Mumbai, India

RECRUITING

Institute Rotary Cancer Hospital

New Delhi, India

RECRUITING

Cipto Magunkusumo General Hospital, University of Indonesia

Jakarta, 10430, Indonesia

RECRUITING

Bahawalpur Institute of Nuclear Medicine and Oncology (BINO)

Bahawalpur, Pakistan

RECRUITING

St Luke's Medical Centre, Quezon City

Manila, Philippines

RECRUITING

University of Pretoria

Pretoria, South Africa

RECRUITING

Mahidol University Faculty of Medicine Siriraj Hospital

Bangkok, Siriraj, 10700, Thailand

RECRUITING

Centro de Lucha contra el Cáncer

Montevideo, Uruguay

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Soren Bentzen

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten I Hopkins, MD FRCP FRCR

CONTACT

+431260022401k.hopkins@iaea.org

Oleg Belyakov, PhD

CONTACT

+431260021667O.Belyakov@iaea.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 6, 2016

Study Start

March 1, 2014

Primary Completion

November 1, 2020

Study Completion

November 1, 2021

Last Updated

August 8, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

IN(3)PA(1)AR(1)UR(1)CU(1)ZA(1)PH(1)ID(1)TH(1)