Cisplatin Plus Raltitrexed or 5-fluorouracil Concurrent With Radiotherapy for Head and Neck Squamous Cell Cancer

Study Overview
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Brief Summary
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This study is a multicenter phase Ⅲ trial. The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.

Detailed Description
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The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.

Official Title
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A Multicenter Phase Ⅲ Trial of Cisplatin Plus Raltitrexed or 5-fluorouracil in Concurrence With Intensity-modulated Radiotherapy (IMRT) for the Treatment of Locoregionally Advanced Head and Neck Squamous Cell Cancer

Conditions
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Head and Neck Squamous Cell Cancer

Intervention / Treatment
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* Drug: Raltitrexed
* Drug: 5-fluorouracil
* Drug: Cisplatin
* Radiation: IMRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed untreated head and neck squamous cell cancer patients 18-70 years Clinical stage: T3-4N0-3M0 or T1-4N1-3M0 Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL Renal function: Cr ≤ 1.25×UNL Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL ECOG ≤ 1 Woman and man of childbearing age must adopt contraception With written consent Exclusion Criteria: Malignant history Pregnant or lactating women With other severe diseases (blood, liver ,kidney or heart diseases) Subjects not suitable for chemo-radiotherapy Without written consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Raltitrexed plus cisplatin<br>Raltitrexed plus cisplatin and IMRT | Drug: Raltitrexed<br>* Patients will receive IMRT and concurrent raltitrexed and cisplatin<br>Drug: Cisplatin<br>* All patients will receive concurrent cisplatin.<br>Radiation: IMRT<br>* All patients will receive IMRT<br>|
| Active Comparator: 5-fluorouracil plus cisplatin<br>5-fluorouracil plus cisplatin and IMRT | Drug: 5-fluorouracil<br>* Patients will receive IMRT and concurrent 5-Fu and cisplatin<br>Drug: Cisplatin<br>* All patients will receive concurrent cisplatin.<br>Radiation: IMRT<br>* All patients will receive IMRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | 36 months | 
| Locoregional and distant control rate |  | 36 months | 
| Percentage of participants experiencing grade 3-5 adverse events(AEs) |  | 36 months |