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

NCT ID: NCT01507467

Last Updated: 2016-11-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-05-31

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.

Conditions

Head and Neck Carcinoma

Keywords

Head and neck carcinoma; Accelerated radiotherapy; Hypoxic modification with Nimorazole

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Accl. RT

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

Group Type: ACTIVE_COMPARATOR

Accl. RT

Intervention Type: RADIATION

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

Accl. RT + Nimorazole

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

Group Type: EXPERIMENTAL

Accl. RT

Intervention Type: RADIATION

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

Accl. radiotherapy + Nimorazole

Intervention Type: RADIATION

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

Interventions

Accl. RT

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

Intervention Type: RADIATION

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

Intervention Type: RADIATION

Other Intervention Names

Radiation Oncology, Accelerated fractionation; Hypoxic radiosensitizer, Nimorazole, Nimoral

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Atomic Energy Agency

OTHER_GOV

Sponsor Role: collaborator

Danish Center for Interventional Research in Radiation Oncology (CIRRO)

OTHER

Sponsor Role: collaborator

Danish Head and Neck Cancer Group

NETWORK

Sponsor Role: lead

Responsible Party

Jens Overgaard

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jens Overgaard, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark

Mohamed Hassan, MD

Role: STUDY_DIRECTOR

Study Coordinator

Locations

Radiation Oncology Department, National Cancer Institute

Cairo, , Egypt

Radiation Oncology Center

Tallinn, , Estonia

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, , Pakistan

Institute of Oncology Department of Radiation Oncology

Ljubljana, , Slovenia

Countries

India; Poland; Egypt; Estonia; Pakistan; Slovenia

Other Identifiers

IAEA-HypoX

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IAEA-HypoX

Identifier Type: -

Identifier Source: org_study_id