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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
International Atomic Energy Agency
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Information provided by (Responsible Party):
Jens Overgaard, Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier:
NCT01507467
First received: August 14, 2011
Last updated: January 10, 2012
Last verified: January 2012

August 14, 2011
January 10, 2012
January 2012
September 2014   (final data collection date for primary outcome measure)
Locoregional control after curative intended radiotherapy +/- Nimorazole [ Time Frame: 5-years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01507467 on ClinicalTrials.gov Archive Site
  • Disease specific survival [ Time Frame: 5.years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5-years ] [ Designated as safety issue: No ]
  • Treatment related morbidity [ Time Frame: 5-years ] [ Designated as safety issue: Yes ]
    Treatment related acute and late morbidity releted to radiotherapy and/or nimorazole treatment
Same as current
Not Provided
Not Provided
 
IAEA-HypoX. Accelerated Radiotherapy With or Without Nimorazole in Squamous Cell Carcinoma of the Head and Neck
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

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Carcinoma
  • Radiation: Accl. RT
    Accelerated Radiotherapy: Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
    Other Name: Radiation Oncology, Accelerated fractionation
  • 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
    Other Name: Hypoxic radiosensitizer, Nimorazole, Nimoral
  • Active Comparator: Accl. RT
    Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
    Intervention: Radiation: Accl. RT
  • Experimental: Accl. RT + Nimorazole
    Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week + Nimorazole
    Interventions:
    • Radiation: Accl. RT
    • Radiation: Accl. radiotherapy + Nimorazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
September 2016
September 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India,   Slovenia,   Pakistan,   Estonia,   Egypt,   Poland
 
NCT01507467
IAEA-HypoX, IAEA-HypoX
Yes
Jens Overgaard, Danish Head and Neck Cancer Group
Danish Head and Neck Cancer Group
  • International Atomic Energy Agency
  • Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Principal Investigator: Jens Overgaard, MD Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark
Study Director: Mohamed Hassan, MD Study Coordinator
Danish Head and Neck Cancer Group
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP