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OpenTrials
Completed

NCT Number: NCT00916097

NPC Study : TAX + CIS Neoadjuvant in Patients With Loco Regionally Advanced Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT)

Primary Objective:

To estimate the overall response rate after neo-adjuvant chemotherapy of Docetaxel 75 mg/m2 in combination with Cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional radiotherapy in UCNT.

Secondary Objectives:

To evaluate:

* The radiological response after chemotherapy and radiotherapy * The pathological response after chemotherapy by cavum biopsy

To estimate:

* The duration of overall response * The time to progression (T.T.P)

To analyze:

* The overall survival * The safety profile

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Algiers, Algeria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written or witnessed oral informed consent prior to beginning specific protocol procedures >Histologically proven undifferentiated carcinoma of nasopharyngeal type (UCNT- stage II-III OMS) at first diagnosis
  • Staging of disease: stage III, IV A, IV B (UICC/AJCC, 1997 classification), any T, N2 - N3 UCNT, without metastasis
  • Adenopathy > 3 cm
  • Patients are required to have an unidimensionally measurable disease with RECIST method
  • Performance status 1 or karnofsky index 3
  • Previous therapy: Chemotherapy :none Radiation therapy: none Surgery: none
  • Laboratory requirements

Exclusion criteria

  • Prior chemotherapy or / and radiotherapy
  • Metastatic disease (M as per the UCCI/AJC classification)
  • Past or current history of neoplasm other than UCNT, except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix or other cancer,curatively treated and with no evidence of disease at the previous 5 years
  • Pregnant, or lacting, patients of childbearing potential must implement adequate contraceptive measures during study participation
  • Pre-existing motor or sensory neurotoxicity of a severity 3 grade 2 according to NCI criteria
  • Others serious illness or medical condition:

1.Congestive heart failure or unstable angina pectoris even if it is medically controlled 2.Previous history of myocardial infraction within 1 year from study entry 3.Uncontrolled hypertension or high risk uncontrolled arrhythmias 4.Uncontrolled peptic ulcer, unstable diabetes mellitus susceptible to contraindicate any use of corticoids 5.Concomitant treatment with corticoids initiated > 6 months prior to study entry is given to the dose of methylprednisolone or equivalent 3 20 mg 6.Definite contraindications for the use of Corticoids 7.Concurrent treatment with other experimental drugs 8.Participation in another clinical with any investigational drug within 30 days prior to study entry 9.Performance status = 2,3,4 or karnofsky index < 80 10. History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

DOCETAXEL(XRP6976)

Drug

docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle

Primary outcomes

  1. Evaluation of tumor response in patients with measurable disease according to RECIST criteria

    Time frame: on day 21 of each treatment cycle for neoadjuvant chemotherapy, on day 64 and day 71 (3 to 4 weeks after the third chemotherapy)

Secondary outcomes

  1. Evaluation of the radiological response after chemotherapy and radiotherapy

    Time frame: from baseline to the end of the study

  2. Evaluation of the pathological response after chemotherapy

    Time frame: between day 64 and day 71 of the treatment

  3. Overall response duration

    Time frame: from baseline to the end of the study

  4. Estimation of the time to progression

    Time frame: from baseline to the end of the study

  5. Overall survival

    Time frame: from baseline to the end of the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Multicenter Phase II Trial of Docetaxel Combined With Cisplatin (CDDP) as a Neo-Adjuvant Chemotherapy in Patients With Loco Regionally Advanced Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT)

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Jun 9, 2009
Registry last updated
Jun 24, 2009

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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