Head and Neck NeoplasmsPhase 3NCT00094081
Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer
A Phase 3 study testing tirapazamine (SR259075), cisplatin and Radiation Therapy in people with Head and Neck Neoplasms, run by Sanofi at 10 sites in United States.
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 Neoplasms
- What is being tested?
- tirapazamine (SR259075), cisplatin and Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 861 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2002to Sep 2006
- 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).
- 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 ULN and AST/ALT < 2.5 times ULN.
- Calculated creatinine clearance (Cockcroft-Gault) > 55 mL/min.
Who cannot join
- Metastatic Disease
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21231
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago Medical Center
Chicago, Illinois, 60637
Harper Hospital
Detroit, Michigan, 48201
VA New Jersey Health Care Medical Center
East Orange, New Jersey, 07018
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Stanford University Medical Center
Palo Alto, California, 94305
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013
University of Rochester Medical Center
Rochester, New York, 14620
H-Lee Moffitt Cancer Center and Research
Tampa, Florida, 33612
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 Neoplasms
- Being tested
- tirapazamine (SR259075), cisplatin, Radiation Therapy
- Keywords
- squamous cell carcinoma, oropharynx, oral cavity, larynx, hypopharynx
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tirapazamine (SR259075)Drug
cisplatinDrug
Radiation TherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival.
Secondary outcomes (1)
Time to locoregional failure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2004 (estimated)
- Study startOct 2002
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies 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
- 861 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094081
- Sponsor's protocol ID
- EFC4690
- Other IDs
- SR259075
- Status last verified
- Feb 2010
- First submitted
- 11 Oct 2004
- Last updated
- 15 Feb 2010
- Results posted
- No
Publications
Ringash J, Fisher R, Peters L, Trotti A, O'Sullivan B, Corry J, Kenny L, Nuyts S, Wratten C, Rischin D. Effect of p16 Status on the Quality-of-Life Experience During Chemoradiation for Locally Advanced Oropharyngeal Cancer: A Substudy of Randomized Trial Trans-Tasman Radiation Oncology Group (TROG) 02.02 (HeadSTART). Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):678-686. doi: 10.1016/j.ijrobp.2016.03.017. Epub 2016 Mar 23.
PubMed 27209505
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. 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
- NCT00094081
- Acronym / sponsor ID
- EFC4690
- Conditions
- Head and Neck Neoplasms
- Keywords
- squamous cell carcinoma, oropharynx, oral cavity, larynx, hypopharynx
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 861 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 14 Oct 2004 (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)
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).
- 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 ULN and AST/ALT < 2.5 times ULN.
Key exclusion criteria (1 listed)
- Metastatic Disease
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 |
|---|---|---|
| tirapazamine (SR259075) | Drug | – |
| cisplatin | Drug | – |
| Radiation Therapy | Procedure or surgery | – |
Primary outcome
Overall survival.
1 secondary outcome
Time to locoregional failure.
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 15 Feb 2010.
- Derived from this study: PubMed 27209505Ringash J, Fisher R, Peters L, Trotti A, O'Sullivan B, Corry J, Kenny L, Nuyts S, Wratten C, Rischin D. Effect of p16 Status on the Quality-of-Life Experience During Chemoradiation for Locally Advanced Oropharyngeal Cancer: A Substudy of Randomized Trial Trans-Tasman Radiation Oncology Group (TROG) 02.02 (HeadSTART). Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):678-686. doi: 10.1016/j.ijrobp.2016.03.017. Epub 2016 Mar 23.
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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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tirapazamine (SR259075), cisplatin and Radiation Therapy in people with Head and Neck Neoplasms, run by Sanofi at 10 sites in United States.
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 1 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 15 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00094081, which also lists 1 linked publication.
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 15 Feb 2010.