Nasopharyngeal NeoplasmsPhase 2NCT00436293
Taxotere + Cisplatin in Nasopharyngeal Carcinoma
A Phase 2 study testing Docetaxel and Cisplatin in people with Nasopharyngeal Neoplasms, run by Sanofi at 1 site in Hong Kong.
Trial summary
Primary objective: To assess and compare the toxicities of patients with advanced NPC treated with concurrent cisplatin-radiotherapy with or without neoadjuvant Taxotere (docetaxel) and cisplatin. Secondary objective: To assess tumor control and survival Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Neoplasms
- What is being tested?
- Docetaxel and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteHong Kong
- Study dates
- Dec 2002to Mar 2010
- Phase
- Phase 2
- 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
- International Union against Cancer stages III and IV newly diagnosed NPC
Who cannot join
- Inadequate bone marrow reserve
- Inadequate renal function
- Other primary malignancy
- Evidence of distant metastases
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Study of Concurrent Cisplatin-radiotherapy With or Without Neoadjuvant Chemotherapy Using Taxotere and Cisplatin in Advanced Nasopharyngeal Carcinoma (NPC)
Primary objective:
To assess and compare the toxicities of patients with advanced NPC treated with concurrent cisplatin-radiotherapy with or without neoadjuvant Taxotere (docetaxel) and cisplatin.
Secondary objective:
To assess tumor control and survival
- Conditions
- Nasopharyngeal Neoplasms
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Neo-adjuvant Taxotere followed by cisplatin and radiotherapy Receives: Drug: Docetaxel |
| 2 | Active comparator | Cisplatin and radiotherapy alone without neo-adjuvant chemotherapy Receives: Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response is evaluated by correlating findings on clinical examination, endoscopy, biopsy, Computed tomography or Magnetic resonance imaging as appropriate.
Measured: From administration of drug to end of study
Secondary outcomes (1)
Adverse Events
Measured: From administration of drug to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startDec 2002
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Iris Chan, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436293
- Sponsor's protocol ID
- XRP6976F_6002
- Status last verified
- Nov 2010
- First submitted
- 16 Feb 2007
- Last updated
- 17 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Concurrent Cisplatin-radiotherapy With or Without Neoadjuvant Chemotherapy Using Taxotere and Cisplatin in Advanced Nasopharyngeal Carcinoma (NPC)
- ClinicalTrials.gov ID
- NCT00436293
- Acronym / sponsor ID
- XRP6976F_6002
- Conditions
- Nasopharyngeal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Feb 2007 (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.
Primary objective:
To assess and compare the toxicities of patients with advanced NPC treated with concurrent cisplatin-radiotherapy with or without neoadjuvant Taxotere (docetaxel) and cisplatin.
Secondary objective:
To assess tumor control and survival
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DocetaxelNeo-adjuvant Taxotere followed by cisplatin and radiotherapy |
| 2 | Active comparator | Drug: CisplatinCisplatin and radiotherapy alone without neo-adjuvant chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- International Union against Cancer stages III and IV newly diagnosed NPC
Key exclusion criteria (5 listed)
- Inadequate bone marrow reserve
- Inadequate renal function
- Other primary malignancy
- Evidence of distant metastases
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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/m² | Drug | 1 |
| Cisplatin75 mg/m² | Drug | 2 |
Primary outcome
Treatment response is evaluated by correlating findings on clinical examination, endoscopy, biopsy, Computed tomography or Magnetic resonance imaging as appropriate.
Time frame: From administration of drug to end of study
1 secondary outcome
Adverse Events
Time frame: From administration of drug to end of study
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 17 Nov 2010.
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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.
Iris Chan study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Cisplatin in people with Nasopharyngeal Neoplasms, run by Sanofi at 1 site in Hong Kong.
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 1 inclusion and 5 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 17 Nov 2010. 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 Hong Kong. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Treatment response is evaluated by correlating findings on clinical examination, endoscopy, biopsy, Computed tomography or Magnetic resonance imaging as appropriate. (time frame: From administration of drug to end of study). 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 17 Nov 2010.