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

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ClinicalTrials.gov Identifier: NCT01507467
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : January 11, 2012
Last Update Posted : November 25, 2016
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

Tracking Information
First Submitted Date  ICMJE August 14, 2011
First Posted Date  ICMJE January 11, 2012
Last Update Posted Date November 25, 2016
Study Start Date  ICMJE March 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
Locoregional control after curative intended radiotherapy +/- Nimorazole [ Time Frame: 5-years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01507467 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
  • Disease specific survival [ Time Frame: 5.years ]
  • Overall survival [ Time Frame: 5-years ]
  • Treatment related morbidity [ Time Frame: 5-years ]
    Treatment related acute and late morbidity releted to radiotherapy and/or nimorazole treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IAEA-HypoX. Accelerated Radiotherapy With or Without Nimorazole in Squamous Cell Carcinoma of the Head and Neck
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 28, 2014)
104
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2012)
600
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt,   Estonia,   Pakistan,   Slovenia
Removed Location Countries India,   Poland
 
Administrative Information
NCT Number  ICMJE NCT01507467
Other Study ID Numbers  ICMJE IAEA-HypoX
IAEA-HypoX ( Other Grant/Funding Number: IAEA, CIRRO; Aarhus University, Denmark, AZANTA Denmark )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jens Overgaard, Danish Head and Neck Cancer Group
Study Sponsor  ICMJE Danish Head and Neck Cancer Group
Collaborators  ICMJE
  • International Atomic Energy Agency
  • Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Investigators  ICMJE
Principal Investigator: Jens Overgaard, MD Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark
Study Director: Mohamed Hassan, MD Study Coordinator
PRS Account Danish Head and Neck Cancer Group
Verification Date November 2016

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