Clinical trial NCT00565448: Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Neoplasms
Carcinoma
Keywords: Nasopharyngeal carcinoma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-11-30
Enrollment: 75
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Complete Response (CR)
timeFrame: after the completion of the induction treatment (up to 9 weeks)
Secondary outcomes:
measure: Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group
timeFrame: Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion
measure: Overall Response (OR)
timeFrame: after the completion of the consolidation treatment (up to 18 weeks)
measure: Overall Survival (OS) Rate
timeFrame: 3 years after the end of the consolidation treatment period (up to 40 months from randomization)
Other outcomes:
Locations:
city: Alger
country: Algeria
facility: Investigational Site Number 012001
city: Rio De Janeiro
country: Brazil
facility: Investigational Site Number 076002
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076001
city: Fuzhou
country: China
facility: Investigational Site Number 156005
city: Villejuif Cedex
country: France
facility: Investigational Site Number 250001
city: Ahmedabad
country: India
facility: Investigational Site Number 356003
city: Kolkata
country: India
facility: Investigational Site Number 356004
city: Thiruvananthapuram
country: India
facility: Investigational Site Number 356002
city: Vellore
country: India
facility: Investigational Site Number 356001
city: Jakarta
country: Indonesia
facility: Investigational Site Number 360001
city: Milano
country: Italy
facility: Investigational Site Number 380001
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410001
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410003
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410002
city: Villahermosa
country: Mexico
facility: Investigational Site Number 484001
city: Casablanca
country: Morocco
facility: Investigational Site Number 504001
city: Rabat
country: Morocco
facility: Investigational Site Number 504002
city: Rabat
country: Morocco
facility: Investigational Site Number 504003
city: Quezon City
country: Philippines
facility: Investigational Site Number 608002
city: Bangkok
country: Thailand
facility: Investigational Site Number 764001
city: Chiang Mai
country: Thailand
facility: Investigational Site Number 764002
city: Sousse
country: Tunisia
facility: Investigational Site Number 788002
city: Tunis
country: Tunisia
facility: Investigational Site Number 788003
city: Abacioglu
country: Turkey
facility: Investigational Site Number 792003
city: Ankara
country: Turkey
facility: Investigational Site Number 792001
city: Istanbul
country: Turkey
facility: Investigational Site Number 792002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: