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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


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
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