Back to resultsEfficacy of Chemoradiotherapy After Neoadjuvant Cisplatin and Docetaxel in the Nasopharynx Carcinoma (Tax-Nazo)
Primary Purpose
Head and Neck Neoplasms
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
docetaxel and cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Histologically/cytologically confirmed, patients with stage T2b-T4N1 or TanyN2-3 undifferentiated or nonkeratinized squamous cell carcinoma of nasopharynx who are candidate for curative radiotherapy.
- ECOG Performance Status is 0-1
- Weight loss within last 6 months <10% of body weight
- Acceptable haematological profile (as defined by a leukocyte count ≥ 4000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 1.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis)
Exclusion Criteria:
- Patients with stage IVC or metastatic disease
- Patients treated with chemotherapy for nasopharyngeal cancer
- Patients treated with radiotherapy to head and neck region
- Concomitant use of another anti-cancer therapy
- Patients treated with amifostine or pilocarpine during protocol treatment.
- Unstable medical condition that makes the patient unable to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 6 months, massive pleural, peritoneal or pericardial effusion; or presence of serious uncontrolled infection.
- Presence of other tumours different from carcinoma of the skin except melanoma and carcinoma in situ of the breast and cervix with disease free survival less than 5 years.
- Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used
- Social or psychological condition that render the patient inadequate for the follow-up of the study
- Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Complete response rate after neoadjuvant chemotherapy
Secondary Outcome Measures
Percentage of patients whose is disease controlled locally or regionally
Median length of overall survival
Median length of disease free survival
Percentage of alive patients without metastatis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00772681
Brief Title
Efficacy of Chemoradiotherapy After Neoadjuvant Cisplatin and Docetaxel in the Nasopharynx Carcinoma
Acronym
Tax-Nazo
Official Title
Phase IV Clinical Study Evaluating The Efficacy of Chemoradiotherapy Following Neoadjuvant Treatment With Docetaxel and Cisplatin in Indifferentiated and Non-keratinized Squamous Cell Carcinoma of Nasopharynx
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the efficacy of docetaxel, cisplatin combination in terms of disease free survival.
Time to progression of the disease in terms of local and distant failure; assess the survival time, and assess the objective (clinical and radiological) response rate and the safety of the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
docetaxel and cisplatin
Intervention Description
3 cycles of docetaxel 75mg/m2 and 100mg/m2 cisplatin combination every 3 weeks
Primary Outcome Measure Information:
Title
Complete response rate after neoadjuvant chemotherapy
Time Frame
From the start date of the treatment to the date of first documented progression of disease or at least until 2 years follow-up period
Secondary Outcome Measure Information:
Title
Percentage of patients whose is disease controlled locally or regionally
Time Frame
from the start date of the treatment to the date of first documented local or regional tumor progression
Title
Median length of overall survival
Time Frame
time interval from the date of treatment to the date of death or at least until 2 years follow-up period
Title
Median length of disease free survival
Time Frame
time interval from the date of treatment to the date of death or at least until 2 years follow-up period
Title
Percentage of alive patients without metastatis
Time Frame
from the start date of the treatment to the date of first documented distant metastasis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically/cytologically confirmed, patients with stage T2b-T4N1 or TanyN2-3 undifferentiated or nonkeratinized squamous cell carcinoma of nasopharynx who are candidate for curative radiotherapy.
ECOG Performance Status is 0-1
Weight loss within last 6 months <10% of body weight
Acceptable haematological profile (as defined by a leukocyte count ≥ 4000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 1.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis)
Exclusion Criteria:
Patients with stage IVC or metastatic disease
Patients treated with chemotherapy for nasopharyngeal cancer
Patients treated with radiotherapy to head and neck region
Concomitant use of another anti-cancer therapy
Patients treated with amifostine or pilocarpine during protocol treatment.
Unstable medical condition that makes the patient unable to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 6 months, massive pleural, peritoneal or pericardial effusion; or presence of serious uncontrolled infection.
Presence of other tumours different from carcinoma of the skin except melanoma and carcinoma in situ of the breast and cervix with disease free survival less than 5 years.
Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used
Social or psychological condition that render the patient inadequate for the follow-up of the study
Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edibe Taylan, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Chemoradiotherapy After Neoadjuvant Cisplatin and Docetaxel in the Nasopharynx Carcinoma
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