Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Hypoxia

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Anti-Infective Agents

All Drugs and Chemicals

Nimorazole

Antiprotozoal Agents

Antiparasitic Agents

Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week

Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week + Nimorazole

Accelerated Radiotherapy: Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week

Accl. RT

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

Accl. radiotherapy + Nimorazole

Jens Overgaard, MD

Mohamed Hassan, MD

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.

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.

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

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

Treatment related acute and late morbidity releted to radiotherapy and/or nimorazole treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
IAEA-HypoX. Accelerated Radiotherapy With or Without Nimorazole in Squamous Cell Carcinoma of the Head and Neck	NCT01507467	Head and Neck C...	Accl. RT Accl. radiother...	18 Years -	Danish Head and Neck Cancer Group
IAEA-HypoX. Accelerated Radiotherapy With or Without Nimorazole in Squamous Cell Carcinoma of the Head and Neck	NCT01507467	Head and Neck C...	Accl. RT Accl. radiother...	18 Years -	Danish Head and Neck Cancer Group

Spots Global Cancer Trial Database for hypoxic modification with nimorazole