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

Primary Purpose

Head and Neck Carcinoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Accl. RT
Accl. radiotherapy + Nimorazole
Sponsored by
Danish Head and Neck Cancer Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Carcinoma focused on measuring Head and neck carcinoma, Accelerated radiotherapy, Hypoxic modification with Nimorazole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Radiation Oncology Department, National Cancer Institute
  • Radiation Oncology Center
  • Nuclear Medicine, Oncology & Radiotherapy Institute, Radiation Oncology Department G-8/3
  • Karachi Institute of Radiotherapy and Nuclear Medicine
  • Institute of Radiotherapy and Nuclear Medicine (IRNUM) Hospital Peshawar
  • Institute of Oncology Department of Radiation Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Accl. RT

Accl. RT + Nimorazole

Arm Description

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

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

Outcomes

Primary Outcome Measures

Locoregional control after curative intended radiotherapy +/- Nimorazole

Secondary Outcome Measures

Disease specific survival
Overall survival
Treatment related morbidity
Treatment related acute and late morbidity releted to radiotherapy and/or nimorazole treatment

Full Information

First Posted
August 14, 2011
Last Updated
November 22, 2016
Sponsor
Danish Head and Neck Cancer Group
Collaborators
International Atomic Energy Agency, Danish Center for Interventional Research in Radiation Oncology (CIRRO)
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1. Study Identification

Unique Protocol Identification Number
NCT01507467
Brief Title
IAEA-HypoX. Accelerated Radiotherapy With or Without Nimorazole in Squamous Cell Carcinoma of the Head and Neck
Acronym
IAEA-HypoX
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Head and Neck Cancer Group
Collaborators
International Atomic Energy Agency, Danish Center for Interventional Research in Radiation Oncology (CIRRO)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Carcinoma
Keywords
Head and neck carcinoma, Accelerated radiotherapy, Hypoxic modification with Nimorazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Accl. RT
Arm Type
Active Comparator
Arm Description
Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
Arm Title
Accl. RT + Nimorazole
Arm Type
Experimental
Arm Description
Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week + Nimorazole
Intervention Type
Radiation
Intervention Name(s)
Accl. RT
Other Intervention Name(s)
Radiation Oncology, Accelerated fractionation
Intervention Description
Accelerated Radiotherapy: Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
Intervention Type
Radiation
Intervention Name(s)
Accl. radiotherapy + Nimorazole
Other Intervention Name(s)
Hypoxic radiosensitizer, Nimorazole, Nimoral
Intervention Description
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
Primary Outcome Measure Information:
Title
Locoregional control after curative intended radiotherapy +/- Nimorazole
Time Frame
5-years
Secondary Outcome Measure Information:
Title
Disease specific survival
Time Frame
5.years
Title
Overall survival
Time Frame
5-years
Title
Treatment related morbidity
Description
Treatment related acute and late morbidity releted to radiotherapy and/or nimorazole treatment
Time Frame
5-years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Overgaard, MD
Organizational Affiliation
Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Hassan, MD
Organizational Affiliation
Study Coordinator
Official's Role
Study Director
Facility Information:
Facility Name
Radiation Oncology Department, National Cancer Institute
City
Cairo
Country
Egypt
Facility Name
Radiation Oncology Center
City
Tallin
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Nuclear Medicine, Oncology & Radiotherapy Institute, Radiation Oncology Department G-8/3
City
Islamabad
Country
Pakistan
Facility Name
Karachi Institute of Radiotherapy and Nuclear Medicine
City
Karachi
Country
Pakistan
Facility Name
Institute of Radiotherapy and Nuclear Medicine (IRNUM) Hospital Peshawar
City
Peshawar
Country
Pakistan
Facility Name
Institute of Oncology Department of Radiation Oncology
City
Ljubljana
Country
Slovenia

12. IPD Sharing Statement

Learn more about this trial

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

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