Status:
TERMINATED
IAEA-HypoX. Accelerated Radiotherapy With or Without Nimorazole in Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Danish Head and Neck Cancer Group
Collaborating Sponsors:
International Atomic Energy Agency
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Conditions:
Head and Neck Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 i...
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. Significan...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01507467
Start Date
March 1 2012
End Date
May 1 2016
Last Update
November 25 2016
Active Locations (6)
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1
Radiation Oncology Department, National Cancer Institute
Cairo, Egypt
2
Radiation Oncology Center
Tallinn, Estonia, 13419
3
Nuclear Medicine, Oncology & Radiotherapy Institute, Radiation Oncology Department G-8/3
Islamabad, Pakistan
4
Karachi Institute of Radiotherapy and Nuclear Medicine
Karachi, Pakistan