Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nasopharyngeal Neoplasms; Carcinoma
Intervention: docetaxel (Drug); cisplatin (Drug); 5-fluorouracil (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Clinical Sciences & Operations, Study Director, Affiliation: Sanofi
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants With Complete Response (CR)
Secondary outcome: Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU GroupOverall Response (OR) Overall Survival (OS) Rate
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
Minimum age: 1 Month.
Maximum age: 21 Years.
Gender(s): Both.
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.
Locations and Contacts
Investigational Site Number 012001, Alger 16005, Algeria
Investigational Site Number 076002, Rio De Janeiro 20230-130, Brazil
Investigational Site Number 076001, Sao Paulo 04023-062, Brazil
Investigational Site Number 156005, Fuzhou 350014, China
Investigational Site Number 250001, Villejuif Cedex 94805, France
Investigational Site Number 356003, Ahmedabad 380006, India
Investigational Site Number 356004, Kolkata 700054, India
Investigational Site Number 356002, Thiruvananthapuram 695011, India
Investigational Site Number 356001, Vellore 632004, India
Investigational Site Number 360001, Jakarta 10430, Indonesia
Investigational Site Number 380001, Milano 20133, Italy
Investigational Site Number 410001, Seoul 110-744, Korea, Republic of
Investigational Site Number 410002, Seoul 138-736, Korea, Republic of
Investigational Site Number 410003, Seoul 135-710, Korea, Republic of
Investigational Site Number 484001, Villahermosa 86100, Mexico
Investigational Site Number 504001, Casablanca 20000, Morocco
Investigational Site Number 504002, Rabat 10000, Morocco
Investigational Site Number 504003, Rabat, Morocco
Investigational Site Number 608002, Quezon City, Philippines
Investigational Site Number 764001, Bangkok 10330, Thailand
Investigational Site Number 764002, Chiang Mai 50200, Thailand
Investigational Site Number 788002, Sousse 4000, Tunisia
Investigational Site Number 788003, Tunis 1006, Tunisia
Investigational Site Number 792003, Abacioglu 34662, Turkey
Investigational Site Number 792001, Ankara 06100, Turkey
Investigational Site Number 792002, Istanbul 34303, Turkey
Additional Information
Starting date: November 2007
Last updated: July 2, 2015
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