Cisplatin Plus Raltitrexed or 5-fluorouracil Concurrent With Radiotherapy for Head and Neck Squamous Cell Cancer
Phase 3
- Conditions
- Head and Neck Squamous Cell Cancer
- Interventions
- Registration Number
- NCT02485548
- Lead Sponsor
- Jiangsu Cancer Institute & Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5-fluorouracil plus cisplatin IMRT 5-fluorouracil plus cisplatin and IMRT Raltitrexed plus cisplatin Raltitrexed Raltitrexed plus cisplatin and IMRT Raltitrexed plus cisplatin Cisplatin Raltitrexed plus cisplatin and IMRT Raltitrexed plus cisplatin IMRT Raltitrexed plus cisplatin and IMRT 5-fluorouracil plus cisplatin 5-fluorouracil 5-fluorouracil plus cisplatin and IMRT 5-fluorouracil plus cisplatin Cisplatin 5-fluorouracil plus cisplatin and IMRT
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) 36 months
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) 36 months Percentage of participants experiencing grade 3-5 adverse events(AEs) 36 months Locoregional and distant control rate 36 months
Trial Locations
- Locations (1)
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China