Overview

This trial has been terminated.

Condition head and neck carcinoma
Treatments accl. rt, accl. radiotherapy + nimorazole
Phase phase 3
Sponsor Danish Head and Neck Cancer Group
Collaborator International Atomic Energy Agency
Start date March 2012
End date May 2014
Trial size 104 participants
Trial identifier NCT01507467, IAEA-HypoX

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
accl. rt Radiation Oncology, Accelerated fractionation
Accelerated Radiotherapy: Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
(Experimental)
Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week + Nimorazole
accl. rt Radiation Oncology, Accelerated fractionation
Accelerated Radiotherapy: Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
accl. radiotherapy + nimorazole Hypoxic radiosensitizer, Nimorazole, Nimoral
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

Primary Outcomes

Measure
Locoregional control after curative intended radiotherapy +/- Nimorazole
time frame: 5-years

Secondary Outcomes

Measure
Disease specific survival
time frame: 5.years
Overall survival
time frame: 5-years
Treatment related morbidity
time frame: 5-years

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

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
Principal investigator Jens Overgaard, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Danish Head and Neck Cancer Group.