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 ------------------------------------------ Estudio aleatorizado internacional para evaluar la suma de docetaxel a la combinación de cisplatino-5-fluoruracilo (TCF) vs. cisplatino-5-fluorouracilo (CF) en el tratamiento de inducción del carcinoma nasofaríngeo (CNF) en niños y adolescentes. - Docetaxel Pediatric study in NPC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001211-33-ES

Enrollment

Registered

2007-04-24

Start date

2007-06-20

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children and adolescents newly diagnosed with NPC with measurable disease T2-T4 any NM, of <18 years of age at the time of diagnosis. ---------- Niños y adolescentes recien diagnosticados con CNF con lesiones medibles T2-T4 cualquier NM, de <18 años en el momento del diagnóstico. MedDRA version: 9.1 Level: LLT Classification code 10028793 Term: Nasopharyngeal carcinoma

Interventions

Trade Name: TAXOTERE Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Docetaxel CAS Number: 148408-66-6 Current Sponsor code: sanofi-aventis recherche & développement Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Histological diagnosis of nasopharyngeal carcinoma WHO type II or III • Newly diagnosed disease NPC Stage IIB-IV disease with measurable disease • Ages eligible for study: =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Patients with short life expectancy. • Prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma • Performance status (Appendix C) - Patients = 16 years of age: Lansky 16 years of age: Karnofsky 15 years of age) • Bilirubin > 1.5 times upper limit of normal (ULN) for age • AST or ALT > 2.5 times ULN for age • Positive pregnancy test • Fertile patients unwilling to use effective contraception Clinical Trial Protocol 24 February 2007 EFC10339 Property of the sanofi-aventis group - strictly confidential Page 29 WW-CLIN-PR007-SD-03 VERSION n°03 (22-FEB-2006) • Refusal or inability to give informed consents to participate in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: - to estimate the Complete Response (CR) rate of TCF compared to CF in the Induction treatment of NPC.;Secondary Objective: - to determine of the Safety of TCF in comparison to CF after induction treatment of NPC. - to determine pharmacokinetics (PK) of docetaxel when added to CF will be implemented at cycle 1 of TCF in at least 20 patients. - to determine OR rate of TCF and CF on completion of consolidation (chemo-radiotherapy) treatment of NPC. - to compare overall survival between TCF and CF.;Primary end point(s): Complete response (CR) rate following the Induction treatment is the primary end point of the study. The assessment of CR will be done according to the Response Evaluation Criteria in Solid Tumors (RECIST) after the completion of the induction treatment (3 cycles) and prior to the radiation treatment. MRI is the best currently available and reproducible method to measure target lesions selected for response assessment. All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total, representative of all involved organs should be identified as target lesions and recorded and measured at baseline. CR is defined as the disappearance of all target lesions. An Independent Committee will assess CR rate in this study.	—

Measure

Time frame

Main Objective: - to estimate the Complete Response (CR) rate of TCF compared to CF in the Induction treatment of NPC.;Secondary Objective: - to determine of the Safety of TCF in comparison to CF after induction treatment of NPC. - to determine pharmacokinetics (PK) of docetaxel when added to CF will be implemented at cycle 1 of TCF in at least 20 patients. - to determine OR rate of TCF and CF on completion of consolidation (chemo-radiotherapy) treatment of NPC. - to compare overall survival between TCF and CF.;Primary end point(s): Complete response (CR) rate following the Induction treatment is the primary end point of the study. The assessment of CR will be done according to the Response Evaluation Criteria in Solid Tumors (RECIST) after the completion of the induction treatment (3 cycles) and prior to the radiation treatment. MRI is the best currently available and reproducible method to measure target lesions selected for response assessment. All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total, representative of all involved organs should be identified as target lesions and recorded and measured at baseline. CR is defined as the disappearance of all target lesions. An Independent Committee will assess CR rate in this study.

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Countries

France, Germany, Greece, Italy, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026