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

NCT01507467 | Terminated Phase 3 DMC

• 1 other identifier: IAEA-HypoX
• Study Type: interventional
• Target: 104
• Locations: 4 countries
• Sites: 6

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.

Conditions

Head and Neck Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Locoregional control after curative intended radiotherapy +/- Nimorazole

  5-years

Secondary Outcomes (3)

• Disease specific survival

  5.years

• Overall survival

  5-years

• Treatment related morbidity

  5-years

Study Arms (2)

Accl. RT

ACTIVE COMPARATOR

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

Radiation: Accl. RT

Accl. RT + Nimorazole

EXPERIMENTAL

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

Radiation: Accl. RT; Radiation: Accl. radiotherapy + Nimorazole

Interventions

Accl. RT RADIATION

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

Also known as: Radiation Oncology, Accelerated fractionation

Accl. RT; Accl. RT + Nimorazole

Accl. radiotherapy + Nimorazole 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

Also known as: Hypoxic radiosensitizer, Nimorazole, Nimoral

Accl. RT + Nimorazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Danish Head and Neck Cancer Group: lead
• International Atomic Energy Agency: collaborator
• Danish Center for Interventional Research in Radiation Oncology (CIRRO): collaborator

Study Sites (6)

Radiation Oncology Department, National Cancer Institute

Cairo, Egypt

Location

Radiation Oncology Center

Tallinn, 13419, Estonia

Location

Nuclear Medicine, Oncology & Radiotherapy Institute, Radiation Oncology Department G-8/3

Islamabad, Pakistan

Location

Karachi Institute of Radiotherapy and Nuclear Medicine

Karachi, Pakistan

Location

Institute of Radiotherapy and Nuclear Medicine (IRNUM) Hospital Peshawar

Peshawar, Pakistan

Location

Institute of Oncology Department of Radiation Oncology

Ljubljana, Slovenia

Location

MeSH Terms

Interventions

Radiation; Nimorazole

Intervention Hierarchy (Ancestors)

Physical Phenomena; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jens Overgaard, MD

  Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• Mohamed Hassan, MD

  Study Coordinator

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2011
• First Posted: January 11, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2016
• Last Updated: November 25, 2016

Record last verified: 2016-11

Locations

ES (1); PA (3); EG (1); SL (1)