Concurrent Chemoradiation Versus Induction Docetaxel, Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy in Locally Advanced Hypopharyngeal and Base of Tongue Cancer: A Randomized Phase II Study
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Hypopharyngeal Cancer
Both
Hypopharyngeal Cancer
Trial Information
Concurrent Chemoradiation Versus Induction Docetaxel, Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy in Locally Advanced Hypopharyngeal and Base of Tongue Cancer: A Randomized Phase II Study
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine whether addition of neoadjuvant chemotherapy before definite CCRT increase progression-free survival(PFS) compared with CCRT only
Outcome Time Frame:
18 months after the enrollment of the last patients
Safety Issue:
No
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
2010-10-028
NCT ID:
NCT01312350
Start Date:
November 2010
Completion Date:
Related Keywords:
- Hypopharyngeal Cancer
- neoadjuvant chemotherapy
- definitive chemoradiation therapy
- head and neck cancer
- base of tongue
- Locally advanced
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
- Hypopharyngeal Neoplasms
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