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

NCT01507467 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2016-11-25

No results posted yet for this study

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

Interventions

RADIATION

Accl. RT

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

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

Sponsors & Collaborators

  • International Atomic Energy Agency

    collaborator OTHER_GOV

  • Danish Center for Interventional Research in Radiation Oncology (CIRRO)

    collaborator OTHER

  • Danish Head and Neck Cancer Group

    lead NETWORK

Principal Investigators

  • Jens Overgaard, MD · Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark

  • Mohamed Hassan, MD · Study Coordinator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-05-31
Completion
2016-05-31

Countries

  • Egypt
  • Estonia
  • Pakistan
  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01507467 on ClinicalTrials.gov