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

Arm | Intervention/treatment |
---|---|
Active Comparator: Accl. RT
Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
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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 |
- Locoregional control after curative intended radiotherapy +/- Nimorazole [ Time Frame: 5-years ]
- Disease specific survival [ Time Frame: 5.years ]
- Overall survival [ Time Frame: 5-years ]
- Treatment related morbidity [ Time Frame: 5-years ]Treatment related acute and late morbidity releted to radiotherapy and/or nimorazole treatment

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

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
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 |
Principal Investigator: | Jens Overgaard, MD | Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark | |
Study Director: | Mohamed Hassan, MD | Study Coordinator |
Responsible Party: | Jens Overgaard, Professor, Danish Head and Neck Cancer Group |
ClinicalTrials.gov Identifier: | NCT01507467 |
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 |
Head and neck carcinoma Accelerated radiotherapy Hypoxic modification with Nimorazole |
Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
Head and Neck Neoplasms Neoplasms by Site Nimorazole Antitrichomonal Agents Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |