Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents

Sanofi75 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasopharyngeal Neoplasms Carcinoma

Interventions

Eligibility

Sex: ALLMin age: 1 MonthMax age: 21 Years

Medical Language ↔ Plain English

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 (26)

Investigational Site Number 012001

Algiers, Algeria

Investigational Site Number 076002

Rio de Janeiro, Brazil

Investigational Site Number 076001

São Paulo, Brazil

Investigational Site Number 156005

Fuzhou, China

Investigational Site Number 250001

Villejuif, France

Investigational Site Number 356003

Ahmedabad, India

Investigational Site Number 356004

Kolkata, India

Investigational Site Number 356002

Thiruvananthapuram, India

Investigational Site Number 356001

Vellore, India

Investigational Site Number 360001

Jakarta, Indonesia

...and 16 more locations

Outcomes

Primary Outcomes

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.

Time frame: after the completion of the induction treatment (up to 9 weeks)

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 3 years after the end of the consolidation treatment period (up to 40 months from randomization)