Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypopharyngeal Cancer

Intervention / Treatment
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* Drug: neoadjuvant docetaxel/cisplatin/fluorouracil
* Drug: No treatment before definitive CCRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CCRT only arm<br>no neoadjuvant chemotherapy before definitive CCRT | Drug: No treatment before definitive CCRT<br>* concurrent chemoradiation therapy radiation: 70Gy/35fractions chemotherapy: cisplatin single 100mg/m2/day D1, D22, D43<br>|
| Experimental: neoadjuvant chemotherapy arm<br>2 cycles of TPF chemotherapy before definitive CCRT | Drug: neoadjuvant docetaxel/cisplatin/fluorouracil<br>* 2 cycles of neoadjuvant Docetaxel/cisplatin/5-fluorouracil therapy followed by CCRT Neoadjuvant chemotherapy (docetaxel 75mg/m2 D1, cisplatin 75mg/m2 D1, 5-fluoruracil 759mg/m2/day, D1-4, every 3 weeks) CCRT protocol is same with that of control arm.<br>* Other names: Docetaxel (taxotere);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether addition of neoadjuvant chemotherapy before definite CCRT increase progression-free survival(PFS) compared with CCRT only |  | 18 months after the enrollment of the last patients | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether addtion of neoaduvant chemotherapy increase complete response rate compared with CCRT only |  | 18 months after enrollemnt of last patients | 
| To determine whether addtion of neoaduvant chemotherapy increase organ preservation rate compared with CCRT only |  | 18 months after the enrollment of the last patient | 
| To determine whether addition of neoadjuvant chemotherapy to CCRT increase the number of patients with adverse events compared with CCRT only |  | 18 months after the enrollment of the last patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neoadjuvant chemotherapy, definitive chemoradiation therapy, head and neck cancer, base of tongue, Locally advanced