Efficacy of Chemoradiotherapy After Neoadjuvant Cisplatin and Docetaxel in the Nasopharynx Carcinoma

NCT00772681 | Completed Phase 4

• 1 other identifier: XRP6976F_6007
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• Complete response rate after neoadjuvant chemotherapy

  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 Outcomes (4)

• Percentage of patients whose is disease controlled locally or regionally

  from the start date of the treatment to the date of first documented local or regional tumor progression

• Median length of overall survival

  time interval from the date of treatment to the date of death or at least until 2 years follow-up period

• Median length of disease free survival

  time interval from the date of treatment to the date of death or at least until 2 years follow-up period

• Percentage of alive patients without metastatis

  from the start date of the treatment to the date of first documented distant metastasis

Study Arms (1)

1

EXPERIMENTAL

Drug: docetaxel and cisplatin

Interventions

docetaxel and cisplatin DRUG

3 cycles of docetaxel 75mg/m2 and 100mg/m2 cisplatin combination every 3 weeks

1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Edibe Taylan, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 13, 2008
• First Posted: October 15, 2008
• Study Start: October 1, 2004
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

TU (1)