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

Phase 3

Terminated

• Conditions: Head and Neck Carcinoma
• Interventions: Radiation: Accl. RT; Radiation: Accl. radiotherapy + Nimorazole

• Registration Number: NCT01507467
• Lead Sponsor: Danish Head and Neck Cancer Group

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.

Study Timeline

• Study First Submitted: 2011-08-14
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-11
• Study Start: 2012-03
• Primary Completion: 2014-05
• Study Completion: 2016-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 104

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accl. RT	Accl. RT	Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
Accl. RT + Nimorazole	Accl. RT	Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week + Nimorazole
Accl. RT + Nimorazole	Accl. radiotherapy + Nimorazole	Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week + Nimorazole

Primary Outcome Measures

Name	Time	Method
Locoregional control after curative intended radiotherapy +/- Nimorazole	5-years

Secondary Outcome Measures

Name	Time	Method
Disease specific survival	5.years
Overall survival	5-years
Treatment related morbidity	5-years	Treatment related acute and late morbidity releted to radiotherapy and/or nimorazole treatment

Trial Locations

Locations (6)

Radiation Oncology Department, National Cancer Institute; 🇪🇬 Cairo, Egypt

Nuclear Medicine, Oncology & Radiotherapy Institute, Radiation Oncology Department G-8/3; 🇵🇰 Islamabad, Pakistan

Radiation Oncology Center; 🇪🇪 Tallin, Estonia

Karachi Institute of Radiotherapy and Nuclear Medicine; 🇵🇰 Karachi, Pakistan

Institute of Radiotherapy and Nuclear Medicine (IRNUM) Hospital Peshawar; 🇵🇰 Peshawar, Pakistan

Institute of Oncology Department of Radiation Oncology; 🇸🇮 Ljubljana, Slovenia