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Taxotere + Cisplatin in Nasopharyngeal Carcinoma

A Randomized Phase II Study of Concurrent Cisplatin-radiotherapy With or Without Neoadjuvant Chemotherapy Using Taxotere and Cisplatin in Advanced Nasopharyngeal Carcinoma (NPC)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00436293
Enrollment
61
Registered
2007-02-19
Start date
2002-12-31
Completion date
2010-03-31
Last updated
2010-11-17

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

Conditions

Nasopharyngeal Neoplasms

Brief summary

Primary objective: To assess and compare the toxicities of patients with advanced NPC treated with concurrent cisplatin-radiotherapy with or without neoadjuvant Taxotere (docetaxel) and cisplatin. Secondary objective: To assess tumor control and survival

Interventions

DRUGDocetaxel

75 mg/m²

DRUGCisplatin

75 mg/m²

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* International Union against Cancer stages III and IV newly diagnosed NPC

Exclusion criteria

* Inadequate bone marrow reserve * Inadequate renal function * Other primary malignancy * Evidence of distant metastases The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Design outcomes

Primary

MeasureTime frame
Treatment response is evaluated by correlating findings on clinical examination, endoscopy, biopsy, Computed tomography or Magnetic resonance imaging as appropriate.From administration of drug to end of study

Secondary

MeasureTime frame
Adverse EventsFrom administration of drug to end of study

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026