Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)
Conditions
Hypopharyngeal Cancer
Conditions: official terms
Head and Neck Neoplasms - Hypopharyngeal Neoplasms
Conditions: Keywords
neoadjuvant chemotherapy, definitive chemoradiation therapy, head and neck cancer, base of tongue, Locally advanced
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: neoadjuvant docetaxel/cisplatin/fluorouracil Type: Drug
Name: No treatment before definitive CCRT Type: Drug
Overall Status
Recruiting
Summary
The investigators will examine whether 2-cycles of DFP chemotherapy before definitive concurrent chemoradiation therapy (CCRT) can improve progression-free survival in locally advanced (Stage III & IVM0) hypopharyngeal and base of tongue carcinoma compared to definitive CCRT alone.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically/cytologically proven stage III/IVM0 hypopharyngeal or base of tongue cancer

- One or more evaluable or measurable lesion

- No prior chemotherapy, radiation, or surgery

- ECOG 0-2

Exclusion Criteria:

- Distant metastasis

- Other malignancy
Location
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: keunchil Park, Pf - 822-3410-3459 - kpark@skku.edu
Start Date
November 2010
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page