Larynx CancerPhase 3NCT00169182
Induction CT by Cisplatin, 5FU With or Without Docetaxel in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma
A Phase 3 study testing DOCETAXEL, Cisplatin and 5-Fluoro-3-Pyridinecarboxylic Acid in people with Larynx Cancer and Hypopharynx Cancer, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.
Trial summary
The purpose of the study is to compare two regimen of chemotherapy used as first treatment for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy. The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Larynx Cancer, Hypopharynx Cancer
- What is being tested?
- DOCETAXEL, Cisplatin and 5-Fluoro-3-Pyridinecarboxylic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2001to May 2009
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T3 and T4 larynx and hypopharynx tumor that would be treated with total laryngectomy
- Biopsy proven carcinoma
- Adequate biology
- Performance status 0 or 1
Who cannot join
- Larynx or hypopharynx tumors that could be treated with partial laryngectomy
- Distant metastasis
- Prior surgery, chemotherapy or radiation
- Intercurrent disease that is a contra indication to chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study Comparing Induction Chemotherapy With Docetaxel, Cisplatin, 5FU Versus Cisplatin, 5 FU in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma
The purpose of the study is to compare two regimen of chemotherapy used as first treatment for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy. The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). The aim of the study is to evaluate the potential benefit of the addition of a third drug (Docetaxel) in the chemotherapy regimen. Patients will receive 3 cycles of chemotherapy. Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy.
Read the detailed description
The purpose of the study is to compare two regimen of induction chemotherapy for patients with T3 and T4 larynx or hypopharynx carcinoma that would be treated with total laryngectomy. The aim of the study is to compare the standard regimen (Cisplatin + 5FU) versus the TPF regimen (Taxotere + Cisplatin + 5FU). Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy followed by postoperative radiation.
- Conditions
- Larynx Cancer, Hypopharynx Cancer
- Keywords
- Larynx cancer, Hypopharynx cancer, Chemotherapy, Randomized trial, Larynx preservation
- Medical subject headings
- Laryngeal Neoplasms, Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOCETAXELDrug
75 mg/m 2 on day 1
CisplatinDrug
75 mg/m 2 on day 1
5-Fluoro-3-Pyridinecarboxylic AcidDrug
750 mg/m 2 by 24-hour continuous infusion for 5 days
| Study group | Role | What they receive |
|---|---|---|
| TPF | Experimental | Docetaxel, Cisplatine, 5-FU Receives: Drug: DOCETAXEL; Drug: Cisplatin; Drug: 5-Fluoro-3-Pyridinecarboxylic Acid |
| PF | Active comparator | Cisplatine, 5-FU Receives: Drug: Cisplatin; Drug: 5-Fluoro-3-Pyridinecarboxylic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-years larynx preservation rate
Secondary outcomes (1)
5-years survival rate
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 start15 Dec 2001
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Larynx CancerStudies 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Gilles Calais, MD, Principal investigator, CHU Bretonneau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169182
- Sponsor's protocol ID
- GORTEC 2000-01
- Status last verified
- Feb 2019
- First submitted
- 9 Sep 2005
- Last updated
- 15 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Induction Chemotherapy With Docetaxel, Cisplatin, 5FU Versus Cisplatin, 5 FU in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma
- ClinicalTrials.gov ID
- NCT00169182
- Acronym / sponsor ID
- GORTEC 2000-01
- Conditions
- Larynx Cancer, Hypopharynx Cancer
- Keywords
- Larynx cancer, Hypopharynx cancer, Chemotherapy, Randomized trial, Larynx preservation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et CouUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 15 Dec 2001 (actual)
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (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 purpose of the study is to compare two regimen of chemotherapy used as first treatment for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy. The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). The aim of the study is to evaluate the potential benefit of the addition of a third drug (Docetaxel) in the chemotherapy regimen. Patients will receive 3 cycles of chemotherapy. Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy.
Detailed description
The purpose of the study is to compare two regimen of induction chemotherapy for patients with T3 and T4 larynx or hypopharynx carcinoma that would be treated with total laryngectomy. The aim of the study is to compare the standard regimen (Cisplatin + 5FU) versus the TPF regimen (Taxotere + Cisplatin + 5FU). Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy followed by postoperative radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPF | Experimental | Drug: DOCETAXEL, Drug: Cisplatin, Drug: 5-Fluoro-3-Pyridinecarboxylic AcidDocetaxel, Cisplatine, 5-FU |
| PF | Active comparator | Drug: Cisplatin, Drug: 5-Fluoro-3-Pyridinecarboxylic AcidCisplatine, 5-FU |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- T3 and T4 larynx and hypopharynx tumor that would be treated with total laryngectomy
- Biopsy proven carcinoma
- Adequate biology
- Performance status 0 or 1
Key exclusion criteria (4 listed)
- Larynx or hypopharynx tumors that could be treated with partial laryngectomy
- Distant metastasis
- Prior surgery, chemotherapy or radiation
- Intercurrent disease that is a contra indication to chemotherapy
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 |
|---|---|---|
| DOCETAXEL75 mg/m 2 on day 1 | Drug | TPF |
| Cisplatin75 mg/m 2 on day 1 | Drug | PF, TPF |
| 5-Fluoro-3-Pyridinecarboxylic Acid750 mg/m 2 by 24-hour continuous infusion for 5 days | Drug | PF, TPF |
Primary outcome
3-years larynx preservation rate
1 secondary outcome
5-years survival rate
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 2019.
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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.
Gilles Calais, MD principal investigator
CHU Bretonneau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DOCETAXEL, Cisplatin and 5-Fluoro-3-Pyridinecarboxylic Acid in people with Larynx Cancer and Hypopharynx Cancer, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
3-years larynx preservation rate. 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 15 Feb 2019.