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
18 Years
N/A
Both
Head and Neck Carcinoma
Trial Information
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
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.
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).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Locoregional control after curative intended radiotherapy +/- Nimorazole
Outcome Time Frame:
5-years
Safety Issue:
No
Principal Investigator
Jens Overgaard, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark
Authority:
Denmark: The Regional Committee on Biomedical Research Ethics
Study ID:
IAEA-HypoX
NCT ID:
NCT01507467
Start Date:
January 2012
Completion Date:
September 2016
Related Keywords:
- Head and Neck Carcinoma
- Head and neck carcinoma
- Accelerated radiotherapy
- Hypoxic modification with Nimorazole
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
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