NCT02485548
Unknown
Phase 3
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
Jiangsu Cancer Institute & Hospital1 site in 1 country120 target enrollmentJune 2015
ConditionsHead and Neck Squamous Cell Cancer
Overview
- Phase
- Phase 3
- Intervention
- Raltitrexed
- Conditions
- Head and Neck Squamous Cell Cancer
- Sponsor
- Jiangsu Cancer Institute & Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS)
- Last Updated
- 10 years ago
Overview
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.
Investigators
Dr. Xia He
Director of Radiation Oncology
Jiangsu Cancer Institute & Hospital
Eligibility Criteria
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
- •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
Arms & Interventions
Raltitrexed plus cisplatin
Raltitrexed plus cisplatin and IMRT
Intervention: Raltitrexed
Raltitrexed plus cisplatin
Raltitrexed plus cisplatin and IMRT
Intervention: Cisplatin
Raltitrexed plus cisplatin
Raltitrexed plus cisplatin and IMRT
Intervention: IMRT
5-fluorouracil plus cisplatin
5-fluorouracil plus cisplatin and IMRT
Intervention: 5-fluorouracil
5-fluorouracil plus cisplatin
5-fluorouracil plus cisplatin and IMRT
Intervention: Cisplatin
5-fluorouracil plus cisplatin
5-fluorouracil plus cisplatin and IMRT
Intervention: IMRT
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: 36 months
Secondary Outcomes
- Overall Survival (OS)(36 months)
- Percentage of participants experiencing grade 3-5 adverse events(AEs)(36 months)
- Locoregional and distant control rate(36 months)
Study Sites (1)
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