Head and Neck CarcinomaPhase 3IAEA-HypoXNCT01507467
IAEA-HypoX. Accelerated Radiotherapy With or Without Nimorazole in Squamous Cell Carcinoma of the Head and Neck
A Phase 3 study testing Accl. RT and Accl. radiotherapy + Nimorazole in people with Head and Neck Carcinoma, run by Danish Head and Neck Cancer Group at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Accl. RT and Accl. radiotherapy + Nimorazole
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Mar 2012to May 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Pakistan3 sites
Nuclear Medicine, Oncology & Radiotherapy Institute, Radiation Oncology Department G-8/3
Islamabad
Karachi Institute of Radiotherapy and Nuclear Medicine
Karachi
Institute of Radiotherapy and Nuclear Medicine (IRNUM) Hospital Peshawar
Peshawar
Slovenia1 site
Institute of Oncology Department of Radiation Oncology
Ljubljana
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Accl. RT, Accl. radiotherapy + Nimorazole
- Keywords
- Head and neck carcinoma, Accelerated radiotherapy, Hypoxic modification with Nimorazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accl. RTRadiation
Also called Radiation Oncology, Accelerated fractionation
Accelerated Radiotherapy: Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
Accl. radiotherapy + NimorazoleRadiation
Also called Hypoxic radiosensitizer, Nimorazole, Nimoral
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
| Study group | Role | What they receive |
|---|---|---|
| Accl. RT | Active comparator | Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week Receives: Radiation: Accl. RT |
| Accl. RT + Nimorazole | Experimental | Accelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week + Nimorazole Receives: Radiation: Accl. RT; Radiation: Accl. radiotherapy + Nimorazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional control after curative intended radiotherapy +/- Nimorazole
Measured: 5-years
Secondary outcomes (3)
Disease specific survival
Measured: 5.years
Overall survival
Measured: 5-years
Treatment related morbidity
Treatment related acute and late morbidity releted to radiotherapy and/or nimorazole treatment
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2014
- Study completionMay 2016
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Head and Neck Cancer Group
- Sponsor type
- Research network
- Collaborators
- International Atomic Energy Agency, Danish Center for Interventional Research in Radiation Oncology (CIRRO)
- Responsible party
- Principal investigator, Jens Overgaard, Danish Head and Neck Cancer Group
- Investigators
- Jens Overgaard, MD, Principal investigator, Department of Experimental Clinical Oncology, Aarhus University Hospital, DenmarkMohamed Hassan, MD, Study director, Study Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507467
- Sponsor's protocol ID
- IAEA-HypoX
- Other IDs
- IAEA-HypoX
- Acronym
- IAEA-HypoX
- Status last verified
- Nov 2016
- First submitted
- 14 Aug 2011
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01507467
- Acronym / sponsor ID
- IAEA-HypoX / IAEA-HypoX
- Conditions
- Head and Neck Carcinoma
- Keywords
- Head and neck carcinoma, Accelerated radiotherapy, Hypoxic modification with Nimorazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Danish Head and Neck Cancer GroupResearch network
- Collaborators
- International Atomic Energy Agency, Danish Center for Interventional Research in Radiation Oncology (CIRRO)
- Study start
- Mar 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accl. RT | Active comparator | Radiation: Accl. RTAccelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week |
| Accl. RT + Nimorazole | Experimental | Radiation: Accl. RT, Radiation: Accl. radiotherapy + NimorazoleAccelerated Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week + Nimorazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accl. RTAlso: Radiation Oncology, Accelerated fractionationAccelerated Radiotherapy: Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week | Radiation | Accl. RT, Accl. RT + Nimorazole |
| Accl. radiotherapy + NimorazoleAlso: Hypoxic radiosensitizer, Nimorazole, NimoralRadiation: 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 | Radiation | Accl. RT + Nimorazole |
Primary outcome
Locoregional control after curative intended radiotherapy +/- Nimorazole
Time frame: 5-years
3 secondary outcomes
Disease specific survival
Time frame: 5.years
Overall survival
Time frame: 5-years
Treatment related morbidity
Time frame: 5-years
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Overgaard, MD principal investigator
Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark
Mohamed Hassan, MD study director
Study Coordinator
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Accl. RT and Accl. radiotherapy + Nimorazole in people with Head and Neck Carcinoma, run by Danish Head and Neck Cancer Group at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Pakistan, Egypt, Estonia, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional control after curative intended radiotherapy +/- Nimorazole (time frame: 5-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016.