Efficacy of Chemoradiotherapy After Neoadjuvant Cisplatin... | NCT00772681

NCT00772681

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: docetaxel and cisplatin

Name	Type	Description	Arm Group Labels	Other Names
docetaxel and cisplatin	Drug	3 cycles of docetaxel 75mg/m2 and 100mg/m2 cisplatin combination every 3 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Eligibility Module

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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D000077143	Docetaxel
D002945	Cisplatin