Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00539630
Other study ID # XRP6976F_3501
Secondary ID
Status Completed
Phase Phase 3
First received October 3, 2007
Last updated October 3, 2007
Start date November 2002

Study information

Verified date October 2007
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To describe the clinical response rate in two groups (Docetaxel plus cisplatin plus 5-FU, versus Cisplatin plus 5-FU) after 3 cycle of neoadjuvant chemotherapy.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Histologically or cytologically proven squamous cell carcinoma of the head and neck with locally advanced inoperable disease.

- Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx , larynx or nasopharynx.

- Patients are required to have at least one (bi-or uni-dimensionally) measurable lesion.

- WHO performance status 0 or 1.

- Adequate bone marrow, hepatic and renal functions.

Exclusion Criteria:

- Pregnant and lactating women

- Previous chemotherapy

- Previous radiotherapy for H&N

- Previous surgery for H&N

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Docetaxel


Locations

Country Name City State
Korea, Republic of Sanofi-Aventis Seoul

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed After 2 cycle, 3 cycle and after concurrent chemo/radiotherapy.
Secondary Pathologic response if clinical response of primary tumor is CR at the end of chemotherapy and end of concurrent chemo/ radiotherapy, biopsy of primary tumor site will be performed to evaluate pathologic response rate.
See also
  Status Clinical Trial Phase
Recruiting NCT02743832 - A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma. N/A
Active, not recruiting NCT02229656 - Olaparib and Radiotherapy in Head and Neck Cancer Phase 1
Completed NCT00389727 - Simultaneous Integrated Boost (SIB)- IMRT Phase 2
Recruiting NCT02328391 - STUDY OBSERVATIONAL OF ERLOTINIB AS SECOND LINE TREATMENT IN PATIENTS WITH SQUAMOUS NSCLC AND EGFR NATIVE N/A
Completed NCT00534950 - Randomized Multicenter Study of 5 vs 6 Weekly Fraction of RT in the Treatment of SCC of the Head and Neck N/A
Completed NCT00875381 - Analysis of Melanocytes (Pigment Cells) in Sun-Exposed Skin N/A
Terminated NCT00073450 - Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530) Phase 2
Terminated NCT01441128 - -02341066 and PF-00299804 for Advanced Non-Small Cell Lung Cancer Phase 1
Recruiting NCT05970497 - A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors Phase 1
Completed NCT01362127 - Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia Phase 2
Completed NCT00240682 - Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR Phase 2
Terminated NCT02254044 - Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus Phase 1
Active, not recruiting NCT00829192 - Phase II AK Study in Organ Transplant Patients Phase 2
Completed NCT00313027 - Cervical Nodal Mets in Squamous Cell Carcinoma of H&N - MRI, FDG-PET, & Histopathologic Correlation N/A
Recruiting NCT04564989 - Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
Not yet recruiting NCT06094829 - Tobacco and Alcohol Influence on Oncogenic Drivers and Somatic Evolution in the Oral Mucosa
Recruiting NCT04481256 - TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY N/A
Active, not recruiting NCT02664935 - National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer Phase 2
Terminated NCT02438995 - Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck Phase 1
Terminated NCT00673049 - Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer Phase 3