Head and Neck Squamous Cell CarcinomaPhase 3TRACENCT00174837
TRACE: Tirapazamine-Radiation And Cisplatin Evaluation
A Phase 3 study testing Tirapazamine and Cisplatin in people with Head and Neck Squamous Cell Carcinoma, run by Sanofi at 17 sites in 17 countries.
Trial summary
The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Tirapazamine and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 17 sitesin 17 countries
- Study dates
- Apr 2005to Jan 2008
- 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
- Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
- Stage III or IV disease (excluding T1N1, and T2N1 and metastatic disease).
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
- Absolute neutrophil count at least 1.5 X 10^9/L, platelet count at least 100 X 10^9/L, and hemoglobin > 9g/dL.
- Serum bilirubin < 1.25 times upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine transaminase (ALT) < 2.5 times ULN.
- Calculated creatinine clearance (Cockcroft-Gault) > 55 mL/min.
Who cannot join
- Metastatic Disease
- Primary cancers of the nasal and paranasal cavities and of the nasopharynx
- Significant intercurrent illness that will interfere with the Chemotherapy or Radiation Therapy during the trial
- Symptomatic peripheral neuropathy > grade 2
- Clinically significant hearing impairment
- Significant cardiac disease
Trial locations and contacts
17 sites in 17 countries.
17 sites in 17 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
New Zealand1 site
sanofi-aventis New Zealand administrative office
Macquarie Park
About this study
Official title: Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer
The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Tirapazamine, Cisplatin
- Keywords
- Tirapazamine, Head and Neck Cancer, Cisplatin, Radiation
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirapazamineDrug
Also called SR259075
in combination with cisplatin and concomitant radiation
CisplatinDrug
with concomitant radiation
| Study group | Role | What they receive |
|---|---|---|
| Tirapazamine + Cisplatin | Experimental | Not described Receives: Drug: Tirapazamine; Drug: Cisplatin |
| Cisplatin | Active comparator | Not described Receives: Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Study period
Secondary outcomes (4)
Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure
Measured: Study period
Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final complete response (CR) Rate at Six Months After Completion of Therapy
Measured: Study period
Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy
Measured: Study period
Toxicity and Safety
Measured: Study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Groupe Oncologie Radiotherapie Tete et Cou
- Responsible party
- Sponsor
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174837
- Sponsor's protocol ID
- EFC5512
- Other IDs
- SR259075
- Acronym
- TRACE
- Status last verified
- Apr 2016
- First submitted
- 13 Sep 2005
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00174837
- Acronym / sponsor ID
- TRACE / EFC5512
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Tirapazamine, Head and Neck Cancer, Cisplatin, Radiation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Groupe Oncologie Radiotherapie Tete et Cou
- Study start
- Apr 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 15 Sep 2005 (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 trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirapazamine + Cisplatin | Experimental | Drug: Tirapazamine, Drug: Cisplatin |
| Cisplatin | Active comparator | Drug: Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
- Stage III or IV disease (excluding T1N1, and T2N1 and metastatic disease).
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
- Absolute neutrophil count at least 1.5 X 10^9/L, platelet count at least 100 X 10^9/L, and hemoglobin > 9g/dL.
- Serum bilirubin < 1.25 times upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine transaminase (ALT) < 2.5 times ULN.
Key exclusion criteria (6 listed)
- Metastatic Disease
- Primary cancers of the nasal and paranasal cavities and of the nasopharynx
- Significant intercurrent illness that will interfere with the Chemotherapy or Radiation Therapy during the trial
- Symptomatic peripheral neuropathy > grade 2
- Clinically significant hearing impairment
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 |
|---|---|---|
| TirapazamineAlso: SR259075in combination with cisplatin and concomitant radiation | Drug | Tirapazamine + Cisplatin |
| Cisplatinwith concomitant radiation | Drug | Cisplatin, Tirapazamine + Cisplatin |
Primary outcome
Overall survival
Time frame: Study period
4 secondary outcomes
Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure
Time frame: Study period
Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final complete response (CR) Rate at Six Months After Completion of Therapy
Time frame: Study period
Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy
Time frame: Study period
Toxicity and Safety
Time frame: Study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Related InfoLink provided by the sponsor.
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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.
ICD CSD study director
Sanofi
17 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirapazamine and Cisplatin in people with Head and Neck Squamous Cell Carcinoma, run by Sanofi at 17 sites in 17 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Argentina, Australia, Canada, Chile and 12 more countries. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (time frame: Study period). 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 26 May 2016.