Clinical trial NCT01507467: IAEA-HypoX. Accelerated Radiotherapy With or Without Nimorazole in Squamous Cell Carcinoma of the Head and Neck
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Head and Neck Carcinoma
Keywords: Head and neck carcinoma
Accelerated radiotherapy
Hypoxic modification with Nimorazole
Lead sponsor: Danish Head and Neck Cancer Group
Sponsor class: NETWORK
Collaborators: name: International Atomic Energy Agency
name: Danish Center for Interventional Research in Radiation Oncology (CIRRO)
First posted: 2012-01-11
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Locoregional control after curative intended radiotherapy +/- Nimorazole
timeFrame: 5-years
Secondary outcomes:
measure: Disease specific survival
timeFrame: 5.years
measure: Overall survival
timeFrame: 5-years
measure: Treatment related morbidity
timeFrame: 5-years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Radiation Oncology Department, National Cancer Institute
city: Tallin
country: Estonia
facility: Radiation Oncology Center
city: Islamabad
country: Pakistan
facility: Nuclear Medicine, Oncology & Radiotherapy Institute, Radiation Oncology Department G-8/3
city: Karachi
country: Pakistan
facility: Karachi Institute of Radiotherapy and Nuclear Medicine
city: Peshawar
country: Pakistan
facility: Institute of Radiotherapy and Nuclear Medicine (IRNUM) Hospital Peshawar
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Department of Radiation Oncology
Study officials:
affiliation: Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark
name: Jens Overgaard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Coordinator
name: Mohamed Hassan, MD
role: STUDY_DIRECTOR
References: