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Completed

NCT Number: NCT00565448

Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma 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.

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Key information

Conditions

Nasopharyngeal Neoplasms Carcinoma Head and Neck Neoplasms Nasopharyngeal Carcinoma Nasopharyngeal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

1 month–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number 012001, Algiers, Algeria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

Pharmaceutical form:solution for infusion

Route of administration:intravenous

Other names: Taxotere®, XRP6976

Cisplatin

Drug

Pharmaceutical form:solution for infusion

Route of administration:intravenous

5-fluorouracil

Drug

Pharmaceutical form:solution for infusion

Route of administration:intravenous

Other names: 5-FU

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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).

  2. Overall Response (OR)

    Time frame: 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.

  3. Overall Survival (OS) Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2012
First posted
Nov 30, 2007
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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