Trial · NCT00565448
Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents
NCT00565448, Phase 2, Completed, Sanofi; results first posted 2010-03-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents. Trials, record NCT00565448. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00565448
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents
- NCT number
- NCT00565448
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 75 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Nasopharyngeal Neoplasms, Carcinoma
- Interventions
- docetaxel, cisplatin, 5-fluorouracil
- First posted
- 2007-11-30
- Last updated
- 2015-07-30
- Other registries' IDs
- eudract:2007-001211-33
- Results first posted
- 2010-03-25
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Response (CR) | 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. |
| Secondary | Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group | Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion | 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). |
| Secondary | Overall Response (OR) | after the completion of the consolidation treatment (up to 18 weeks) | 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. |
| Secondary | Overall Survival (OS) Rate | 3 years after the end of the consolidation treatment period (up to 40 months from randomization) | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Complete Response (CR) | after the completion of the induction treatment (up to 9 weeks) | ITT population: all randomized participants. | participants | NUMBER |
| SECONDARY | Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group | Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion | Participants who were randomized to docetaxel/cisplatin/5-FU and had evaluable docetaxel pharmacokinetic (PK) sample. | µg*h/mL | MEAN |
| SECONDARY | Overall Response (OR) | after the completion of the consolidation treatment (up to 18 weeks) | ITT population: all randomized participants. | participants | NUMBER |
| SECONDARY | Overall Survival (OS) Rate | 3 years after the end of the consolidation treatment period (up to 40 months from randomization) | ITT population: all randomized participants. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Complete Response (CR) | Docetaxel /Cisplatin/5-FU | 1 | participants | ||
| Number of Participants With Complete Response (CR) | Cisplatin/5-FU | 0 | participants | ||
| Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group | Docetaxel/Cisplatin/5-FU | 3.43 | Standard Deviation 2.05 | µg*h/mL | |
| Overall Response (OR) | Docetaxel /Cisplatin/5-FU | CR | 1 | participants | |
| Overall Response (OR) | Cisplatin/5-FU | CR | 1 | participants | |
| Overall Response (OR) | Docetaxel /Cisplatin/5-FU | PR | 43 | participants | |
| Overall Response (OR) | Cisplatin/5-FU | PR | 20 | participants | |
| Overall Response (OR) | Docetaxel /Cisplatin/5-FU | SD | 2 | participants | |
| Overall Response (OR) | Cisplatin/5-FU | SD | 1 | participants | |
| Overall Response (OR) | Docetaxel /Cisplatin/5-FU | PD | 2 | participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Docetaxel /Cisplatin/5-FU | 50 | |
| Overall Study | STARTED | Cisplatin/5-FU | 25 | |
| Overall Study | COMPLETED | Docetaxel /Cisplatin/5-FU | 47 | |
| Overall Study | COMPLETED | Cisplatin/5-FU | 23 | |
| Overall Study | NOT COMPLETED | Docetaxel /Cisplatin/5-FU | 3 | |
| Overall Study | NOT COMPLETED | Cisplatin/5-FU | 2 |
Source ClinicalTrials.gov
Adverse events190
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Cisplatin/5-FU | 3 | 25 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Docetaxel /Cisplatin/5-FU | 14 | 50 | |
| other | BONE MARROW FAILURE | Blood and lymphatic system disorders | Cisplatin/5-FU | 1 | 25 | |
| other | BONE MARROW FAILURE | Blood and lymphatic system disorders | Docetaxel /Cisplatin/5-FU | 3 | 50 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Cisplatin/5-FU | 1 | 25 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Docetaxel /Cisplatin/5-FU | 6 | 50 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Cisplatin/5-FU | 0 | 25 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Docetaxel /Cisplatin/5-FU | 6 | 50 | |
| other | NEUTROPENIA/NEUTROPHIL COUNT | Blood and lymphatic system disorders | Cisplatin/5-FU | 7 | 25 | |
| other | NEUTROPENIA/NEUTROPHIL COUNT | Blood and lymphatic system disorders | Docetaxel /Cisplatin/5-FU | 20 | 50 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cisplatin/5-FU | ||
| Total, all-cause mortality | Docetaxel /Cisplatin/5-FU | ||
| Total, other adverse events | Cisplatin/5-FU | 23 | 25 |
| Total, other adverse events | Docetaxel /Cisplatin/5-FU | 49 | 50 |
| Total, serious adverse events | Cisplatin/5-FU | 11 | 25 |
| Total, serious adverse events | Docetaxel /Cisplatin/5-FU | 20 | 50 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Docetaxel /Cisplatin/5-FU vs Cisplatin/5-FU: Number of Participants With Complete Response (CR) | Trial comparisons |
| Cisplatin/5-FU vs Docetaxel /Cisplatin/5-FU: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00565448
GET https://conductscience.org/api/trials/v1/NCT00565448/events?page=2