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

Head and Neck Carcinoma Clinical Trial

— IAEA-HypoX  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01507467
• Other study ID #: IAEA-HypoX
• Secondary ID: IAEA-HypoX
• Status: Terminated
• Phase: Phase 3
• First received: August 14, 2011
• Last updated: November 22, 2016
• Start date: March 2012
• Est. completion date: May 2016

Study information

• Verified date: November 2016
• Source: Danish Head and Neck Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: May 2016
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Carcinoma
• Head and Neck Neoplasms

Intervention

Radiation:
• Accl. RT
Accelerated Radiotherapy: Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
• 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

Locations

Country	Name	City	State
Egypt	Radiation Oncology Department, National Cancer Institute	Cairo
Estonia	Radiation Oncology Center	Tallin
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
Slovenia	Institute of Oncology Department of Radiation Oncology	Ljubljana

Sponsors (3)

Lead Sponsor	Collaborator
Danish Head and Neck Cancer Group	Danish Center for Interventional Research in Radiation Oncology (CIRRO), International Atomic Energy Agency

Countries where clinical trial is conducted

Egypt,  Estonia,  Pakistan,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional control after curative intended radiotherapy +/- Nimorazole		5-years	No
Secondary	Disease specific survival		5.years	No
Secondary	Overall survival		5-years	No
Secondary	Treatment related morbidity	Treatment related acute and late morbidity releted to radiotherapy and/or nimorazole treatment	5-years	Yes

External Links

•   Trial homepage