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
  Purpose

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.


Condition Intervention Phase
Head and Neck Carcinoma
Radiation: Accl. RT
Radiation: Accl. radiotherapy + Nimorazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Danish Head and Neck Cancer Group:

Primary Outcome Measures:
  • Locoregional control after curative intended radiotherapy +/- Nimorazole [ Time Frame: 5-years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 600
Study Start Date: January 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Accl. RT
Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
Radiation: Accl. RT
Accelerated Radiotherapy: Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
Other Name: Radiation Oncology, Accelerated fractionation
Experimental: Accl. RT + Nimorazole
Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week + Nimorazole
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507467

Locations
Egypt
Radiation Oncology Department, National Cancer Institute
Cairo, Egypt
Estonia
Radiation Oncology Depart-ment North Estonia Regional Hospital
Tallinn, Estonia
India
Postgraduate Institute of Medical Education and Research (PGIMER)
Chandigarh, Punjab, India
Department of Radiation Oncology, Tata Memorial Centre (TMC)
Mumbai, India
Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
New Delhi, India
Pakistan
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
Poland
Radiation Oncology Ward Maria Sklodowska-Curie Memorial
Gliwice, Poland
Slovenia
Institute of Oncology Department of Radiation Oncology
Ljubljana, Slovenia
Sponsors and Collaborators
Danish Head and Neck Cancer Group
International Atomic Energy Agency
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Investigators
Principal Investigator: Jens Overgaard, MD Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark
Study Director: Mohamed Hassan, MD Study Coordinator
  More Information

Additional Information:
No publications provided

Responsible Party: Jens Overgaard, Professor, Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier: NCT01507467     History of Changes
Other Study ID Numbers: IAEA-HypoX, IAEA-HypoX
Study First Received: August 14, 2011
Last Updated: January 10, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Danish Head and Neck Cancer Group:
Head and neck carcinoma
Accelerated radiotherapy
Hypoxic modification with Nimorazole

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Nimorazole
Radiation-Sensitizing Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014