Nasopharyngeal NeoplasmsPhase 2NCT00565448
Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents
A Phase 2 study testing docetaxel, cisplatin and 5-fluorouracil in people with Nasopharyngeal Neoplasms and Carcinoma, run by Sanofi at 26 sites in 14 countries.
Trial summary
The primary objective is to estimate the Complete Response rate of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in the Induction treatment of Nasopharyngeal Carcinoma (NPC). Read more about this study
- Who is it for?
- Ages 1 month to 21 years
- Conditions the study is for
- Nasopharyngeal Neoplasms, Carcinoma
- What is being tested?
- docetaxel, cisplatin and 5-fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 26 sitesin 14 countries
- Study dates
- Nov 2007to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 month to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Histological diagnosis of nasopharyngeal carcinoma World Health Organization (WHO) type II or III
- Children and adolescents newly diagnosed with Stage IIB-IV NPC with measurable disease, who are >1 month to ≤21 years of age at the time of diagnosis. In France, participants must be ≥1 year to ≤21 years of age at the time of diagnosis
Who cannot join
- Participants with short life expectancy
- Prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma
- Inadequate renal function evidenced by unacceptable laboratory results
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
26 sites in 14 countries.
26 sites in 14 countries
India4 sites
Investigational Site Number 356003
Ahmedabad, 380006
Investigational Site Number 356004
Kolkata, 700054
Investigational Site Number 356002
Thiruvananthapuram, 695011
Investigational Site Number 356001
Vellore, 632004
Morocco3 sites
Investigational Site Number 504001
Casablanca, 20000
Investigational Site Number 504002
Rabat, 10000
Investigational Site Number 504003
Rabat
South Korea3 sites
Investigational Site Number 410001
Seoul, 110-744
Investigational Site Number 410003
Seoul, 135-710
Investigational Site Number 410002
Seoul, 138-736
Turkey (Türkiye)3 sites
Investigational Site Number 792003
Abacıoğlu, 34662
Investigational Site Number 792001
Ankara, 06100
Investigational Site Number 792002
Istanbul, 34303
Brazil2 sites
Investigational Site Number 076002
Rio de Janeiro, 20230-130
Investigational Site Number 076001
São Paulo, 04023-062
Thailand2 sites
Investigational Site Number 764001
Bangkok, 10330
Investigational Site Number 764002
Chiang Mai, 50200
Tunisia2 sites
Investigational Site Number 788002
Sousse, 4000
Investigational Site Number 788003
Tunis, 1006
About this study
Official title: International Randomized Study to Evaluate the Addition of Docetaxel to the Combination of Cisplatin-5-fluorouracil (TCF) vs. Cisplatin-5-fluorouracil (CF) in the Induction Treatment of Nasopharyngeal Carcinoma (NPC) in Children and Adolescents
The primary objective is to estimate the Complete Response rate of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in the Induction treatment of Nasopharyngeal Carcinoma (NPC).
The secondary objectives are to determine:
- the safety of TCF in comparison to CF after induction treatment of NPC,
- the pharmacokinetics of docetaxel when added to CF,
- the Overall Response rate of TCF and CF on completion of induction and consolidation (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and CF.
Read the detailed description
Planned treatment duration:
- induction period: 9 weeks of induction treatment
- consolidation period: 9 weeks of chemoradiation treatment.
The consolidation treatment was the same for all participants: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.
- Conditions
- Nasopharyngeal Neoplasms, Carcinoma
- Being tested
- docetaxel, cisplatin, 5-fluorouracil
- Keywords
- Nasopharyngeal carcinoma
- Medical subject headings
- Nasopharyngeal Neoplasms, Carcinoma, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Also called Taxotere®, XRP6976
Pharmaceutical form:solution for infusion
Route of administration:intravenous
cisplatinDrug
Pharmaceutical form:solution for infusion
Route of administration:intravenous
5-fluorouracilDrug
Also called 5-FU
Pharmaceutical form:solution for infusion
Route of administration:intravenous
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel/Cisplatin/5-FU (TCF) | Experimental | * Docetaxel 75 milligrams per square meter (mg/m²) over 1 hour on Day 1 every 3 weeks
* Cisplatin 75 mg/m² Day 1 over 6 hours every 3 weeks
* 5-Fluorouracil 750 mg/m²/day continuous infusion Days 1 to 4 every 3 weeks as an induction therapy
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. Receives: Drug: docetaxel; Drug: cisplatin; Drug: 5-fluorouracil |
| Cisplatin/5-FU (CF) | Active comparator | * Cisplatin 80 mg/m² Day 1 over 6 hours every 3 weeks
* 5-Fluorouracil 1000 mg/m²/day continuous infusion Day 1 to 4 every 3 weeks as an induction therapy.
Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. Receives: Drug: cisplatin; Drug: 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Response (CR)
CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the induction treatment and prior to the radiation treatment. CR defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
Measured: after the completion of the induction treatment (up to 9 weeks)
Secondary outcomes (3)
Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group
AUC estimated by Bayesian method using concentration-time data for each participant and the previously defined adult population model as prior information (with validity of the estimation verified).
Measured: Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion
Overall Response (OR)
OR is classified as CR, partial response (PR), stable disease (SD), progressive disease (PD) or Unknown on completion of both induction and radiation treatment and assessed according to the Modified RECIST from the NCI. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as ≥30% decrease in the sum of the longest diameters (LD) of TLs, taking as reference the disease measurement done at study entry. PD is defined as ≥20% increase in the sum of the LD of TLs, taking as a reference the smallest disease measurement recorded at study entry or the appearance of ≥1 new lesions or unequivocal progression of non-TLs. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: after the completion of the consolidation treatment (up to 18 weeks)
Overall Survival (OS) Rate
OS rate is the percentage of participants who survived 3 years after completion of consolidation treatment period. The Kaplan-Meier method was used to estimate OS rate.
Measured: 3 years after the end of the consolidation treatment period (up to 40 months from randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionMar 2009
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565448
- Sponsor's protocol ID
- EFC10339
- Other IDs
- 2007-001211-33
- Status last verified
- Jul 2015
- First submitted
- 29 Nov 2007
- Last updated
- 30 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Randomized Study to Evaluate the Addition of Docetaxel to the Combination of Cisplatin-5-fluorouracil (TCF) vs. Cisplatin-5-fluorouracil (CF) in the Induction Treatment of Nasopharyngeal Carcinoma (NPC) in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00565448
- Acronym / sponsor ID
- EFC10339
- Conditions
- Nasopharyngeal Neoplasms, Carcinoma
- Keywords
- Nasopharyngeal carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 30 Nov 2007 (estimated)
- Results
- Posted 25 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to estimate the Complete Response rate of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in the Induction treatment of Nasopharyngeal Carcinoma (NPC).
The secondary objectives are to determine:
- the safety of TCF in comparison to CF after induction treatment of NPC,
- the pharmacokinetics of docetaxel when added to CF,
- the Overall Response rate of TCF and CF on completion of induction and consolidation (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and CF.
Detailed description
Planned treatment duration:
- induction period: 9 weeks of induction treatment
- consolidation period: 9 weeks of chemoradiation treatment.
The consolidation treatment was the same for all participants: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel/Cisplatin/5-FU (TCF) | Experimental | Drug: docetaxel, Drug: cisplatin, Drug: 5-fluorouracil* Docetaxel 75 milligrams per square meter (mg/m²) over 1 hour on Day 1 every 3 weeks * Cisplatin 75 mg/m² Day 1 over 6 hours every 3 weeks * 5-Fluorouracil 750 mg/m²/day continuous infusion Days 1 to 4 every 3 weeks as an induction therapy Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. |
| Cisplatin/5-FU (CF) | Active comparator | Drug: cisplatin, Drug: 5-fluorouracil* Cisplatin 80 mg/m² Day 1 over 6 hours every 3 weeks * 5-Fluorouracil 1000 mg/m²/day continuous infusion Day 1 to 4 every 3 weeks as an induction therapy. Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. |
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Histological diagnosis of nasopharyngeal carcinoma World Health Organization (WHO) type II or III
- Children and adolescents newly diagnosed with Stage IIB-IV NPC with measurable disease, who are >1 month to ≤21 years of age at the time of diagnosis. In France, participants must be ≥1 year to ≤21 years of age at the time of diagnosis
Key exclusion criteria (4 listed)
- Participants with short life expectancy
- Prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma
- Inadequate renal function evidenced by unacceptable laboratory results
- The above information is not intended to contain all considerations relevant to a participant'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 |
|---|---|---|
| docetaxelAlso: Taxotere®, XRP6976Pharmaceutical form:solution for infusion Route of administration:intravenous | Drug | Docetaxel/Cisplatin/5-FU (TCF) |
| cisplatinPharmaceutical form:solution for infusion Route of administration:intravenous | Drug | Cisplatin/5-FU (CF), Docetaxel/Cisplatin/5-FU (TCF) |
| 5-fluorouracilAlso: 5-FUPharmaceutical form:solution for infusion Route of administration:intravenous | Drug | Cisplatin/5-FU (CF), Docetaxel/Cisplatin/5-FU (TCF) |
Primary outcome
Number of Participants With Complete Response (CR)
Time frame: after the completion of the induction treatment (up to 9 weeks)
CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the induction treatment and prior to the radiation treatment. CR defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
3 secondary outcomes
Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group
Time frame: Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion
Overall Response (OR)
Time frame: after the completion of the consolidation treatment (up to 18 weeks)
Overall Survival (OS) Rate
Time frame: 3 years after the end of the consolidation treatment period (up to 40 months from randomization)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Sciences & Operations study director
Sanofi
26 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel, cisplatin and 5-fluorouracil in people with Nasopharyngeal Neoplasms and Carcinoma, run by Sanofi at 26 sites in 14 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 2 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 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in India, Morocco, South Korea, Turkey (Türkiye), Brazil and 9 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 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?
Yes. Results are posted in the registry (first posted 25 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Complete Response (CR) (time frame: after the completion of the induction treatment (up to 9 weeks)). 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 30 Jul 2015.