IAEA-HypoX. Accelerated Radiotherapy With or Without Nimorazole in Squamous Cell Carcinoma of the Head and Neck (IAEA-HypoX)

November 22, 2016 updated by: Jens Overgaard, Danish Head and Neck Cancer Group

IAEA-HypoX. A Randomized Multicenter Study of Accelerated Fractionated Radiotherapy With or Without the Hypoxic Radiosensitizer Nimorazole in the Treatment of Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to test the hypothesis that radiotherapy of head and neck carcinoma can be improved by hypoxic modification of radiotherapy using nimorazole as a hypoxic radiosensitizer in association with accelerated fractionation, in an unselected patient population in a global environment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Squamous cell carcinoma in the head & neck region (HNSCC) accounts for approximately 7% of all cancers worldwide & around 75% of all HNSCC cases are seen in the less developed countries.

Significant improvement in loco-regional control & disease specific survival by radiation therapy could be achieved by reducing the overall treatment time by "Accelerated Fractionation" schedule.

Modification of hypoxia by Nimorazole demonstrated significant improved local effect of radiation with neither serious nor lasting side effects. So, it is expected that the optimal treatment option is reducing the overall treatment time with concomitant use of Nimorazole. Such treatment principle is optimal for testing in developing countries.

The aim of the study:

  • To determine the possible therapeutic gain of using nimorazole given as a hypoxic radiosensitizer in conjunction with accelerated fractionated radiotherapy of invasive squamous cell carcinoma of the larynx, pharynx and oral cavity, and
  • To determine whether the addition of Nimorazole to primary curative radiotherapy is feasible and tolerable on a worldwide scale.
  • To evaluate the tolerance, compliance and toxicity of using nimorazole.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Radiation Oncology Department, National Cancer Institute
  • Estonia
      • Tallin, Estonia, 13419
        • Radiation Oncology Center
  • Pakistan
      • Islamabad, Pakistan
        • Nuclear Medicine, Oncology & Radiotherapy Institute, Radiation Oncology Department G-8/3
      • Karachi, Pakistan
        • Karachi Institute of Radiotherapy and Nuclear Medicine
      • Peshawar, Pakistan
        • Institute of Radiotherapy and Nuclear Medicine (IRNUM) Hospital Peshawar
  • Slovenia
      • Ljubljana, Slovenia
        • Institute of Oncology Department of Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 in the primary tumor.
  • Informed consent according to the Helsinki declaration and local regula-tions.
  • The patient must be candidate for external beam radical radiotherapy, and must be expected to accomplish the treatment.
  • Performance status 0-2 according to WHO criteria.
  • The patient should not have symptoms of peripheral neuropathy assessed by clinical examination.
  • Normal function of liver and kidney by routine laboratory examinations. The patient must not be pregnant

Exclusion Criteria:

  • Distant metastases.
  • The patient should not be in a state or condition that could be expected to influence the outcome of treatment, or complicate the assessment or the treatment follow-up, or (apart from the present disease) reduce the life expectancy.
  • Surgical excision (except biopsy), prior or planned (including elective neck dissection).
  • The existence of synchronous multiple malignancies (not leukoplakia).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Accl. RT
Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
Radiation: Accl. RT
Accelerated Radiotherapy: Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
Other Names:
  • Radiation Oncology, Accelerated fractionation
EXPERIMENTAL: Accl. RT + Nimorazole
Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week + Nimorazole
Radiation: Accl. RT
Accelerated Radiotherapy: Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
Other Names:
  • Radiation Oncology, Accelerated fractionation
Radiation: Accl. radiotherapy + Nimorazole
Radiation: Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week plus Nimorazole (tablets or powder) 1.2 g/m2 body surface in connection with the first daily radiation treatments
Other Names:
  • Hypoxic radiosensitizer, Nimorazole, Nimoral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Locoregional control after curative intended radiotherapy +/- Nimorazole
Time Frame: 5-years
5-years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5-years
5-years
Disease specific survival
Time Frame: 5.years
5.years
Treatment related morbidity
Time Frame: 5-years
Treatment related acute and late morbidity releted to radiotherapy and/or nimorazole treatment
5-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Head and Neck Cancer Group

Collaborators

International Atomic Energy Agency
Danish Center for Interventional Research in Radiation Oncology (CIRRO)

Investigators

  • Principal Investigator: Jens Overgaard, MD, Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark
  • Study Director: Mohamed Hassan, MD, study coordinator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

August 14, 2011

First Submitted That Met QC Criteria

January 10, 2012

First Posted (ESTIMATE)

January 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAEA-HypoX (OTHER_GRANT: IAEA, CIRRO; Aarhus University, Denmark, AZANTA Denmark)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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