Cisplatin Plus Raltitrexed or 5-fluorouracil Concurrent With Radiotherapy for Head and Neck Squamous Cell Cancer
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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2015
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 26, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJune 30, 2015
June 1, 2015
3 years
June 26, 2015
June 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
36 months
Secondary Outcomes (3)
Overall Survival (OS)
36 months
Locoregional and distant control rate
36 months
Percentage of participants experiencing grade 3-5 adverse events(AEs)
36 months
Study Arms (2)
Raltitrexed plus cisplatin
EXPERIMENTALRaltitrexed plus cisplatin and IMRT
5-fluorouracil plus cisplatin
ACTIVE COMPARATOR5-fluorouracil plus cisplatin and IMRT
Interventions
Patients will receive IMRT and concurrent raltitrexed and cisplatin
Patients will receive IMRT and concurrent 5-Fu and cisplatin
All patients will receive concurrent cisplatin.
Eligibility Criteria
You may qualify if:
- Pathologically confirmed untreated head and neck squamous cell cancer patients
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jiangsu Cancer Institute & Hospitallead
- Affiliated Hospital of Jiangnan Universitycollaborator
- Changzhou Cancer Hospital of Soochow Universitycollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- Northern Jiangsu People's Hospitalcollaborator
- The Second Hospital of Nanjing Medical Universitycollaborator
- Nanjing BenQ Hospitalcollaborator
Study Sites (1)
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xia He, M.D.
Jiangsu Cancer Institute & Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Radiation Oncology
Study Record Dates
First Submitted
June 26, 2015
First Posted
June 30, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
June 30, 2015
Record last verified: 2015-06