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

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ClinicalTrials.gov Identifier: NCT01507467
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : January 11, 2012
Last Update Posted : November 25, 2016
Sponsor:
Collaborators:
International Atomic Energy Agency
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Information provided by (Responsible Party):
Jens Overgaard, Danish Head and Neck Cancer Group

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Head and Neck Carcinoma Radiation: Accl. RT Radiation: Accl. radiotherapy + Nimorazole Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: Hypoxic radiosensitizer, Nimorazole, Nimoral


Outcome Measures
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Primary Outcome Measures :
  1. Locoregional control after curative intended radiotherapy +/- Nimorazole [ Time Frame: 5-years ]

Secondary Outcome Measures :
  1. Disease specific survival [ Time Frame: 5.years ]
  2. Overall survival [ Time Frame: 5-years ]
  3. Treatment related morbidity [ Time Frame: 5-years ]
    Treatment related acute and late morbidity releted to radiotherapy and/or nimorazole treatment


Eligibility Criteria
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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:

  • 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).
Contacts and Locations
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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): NCT01507467


Locations
Egypt
Radiation Oncology Department, National Cancer Institute
Cairo, Egypt
Estonia
Radiation Oncology Center
Tallin, Estonia, 13419
Pakistan
Nuclear Medicine, Oncology & Radiotherapy Institute, Radiation Oncology Department G-8/3
Islamabad, Pakistan
Karachi Institute of Radiotherapy and Nuclear Medicine
Karachi, Pakistan
Institute of Radiotherapy and Nuclear Medicine (IRNUM) Hospital Peshawar
Peshawar, Pakistan
Slovenia
Institute of Oncology Department of Radiation Oncology
Ljubljana, Slovenia
Sponsors and Collaborators
Danish Head and Neck Cancer Group
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
More Information
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Additional Information:
Trial homepage  This link exits the ClinicalTrials.gov site

Responsible Party: Jens Overgaard, Professor, Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier: NCT01507467     History of Changes
Other Study ID Numbers: IAEA-HypoX
IAEA-HypoX ( Other Grant/Funding Number: IAEA, CIRRO; Aarhus University, Denmark, AZANTA Denmark )
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016

Keywords provided by Jens Overgaard, Danish Head and Neck Cancer Group:
Head and neck carcinoma
Accelerated radiotherapy
Hypoxic modification with Nimorazole

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
Nimorazole
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents