- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02485548
Cisplatin Plus Raltitrexed or 5-fluorouracil Concurrent With Radiotherapy for Head and Neck Squamous Cell Cancer
June 29, 2015 updated by: Dr. Xia He, Jiangsu Cancer Institute & Hospital
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xuesong Jiang, M.D.
- Phone Number: 86138517007
- Email: 13851700790@126.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Recruiting
- Jiangsu Cancer Hospital
-
Contact:
- Xuesong Jiang, M.D.
- Email: 13851700790@126.com
-
Sub-Investigator:
- Xuesong Jiang, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Raltitrexed plus cisplatin
Raltitrexed plus cisplatin and IMRT
|
Patients will receive IMRT and concurrent raltitrexed and cisplatin
All patients will receive concurrent cisplatin.
All patients will receive IMRT
|
Active Comparator: 5-fluorouracil plus cisplatin
5-fluorouracil plus cisplatin and IMRT
|
All patients will receive concurrent cisplatin.
All patients will receive IMRT
Patients will receive IMRT and concurrent 5-Fu and cisplatin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival (PFS)
Time Frame: 36 months
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival (OS)
Time Frame: 36 months
|
36 months
|
Locoregional and distant control rate
Time Frame: 36 months
|
36 months
|
Percentage of participants experiencing grade 3-5 adverse events(AEs)
Time Frame: 36 months
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Xia He, M.D., Jiangsu Cancer Institute & Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Anticipated)
June 1, 2018
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
June 26, 2015
First Submitted That Met QC Criteria
June 29, 2015
First Posted (Estimate)
June 30, 2015
Study Record Updates
Last Update Posted (Estimate)
June 30, 2015
Last Update Submitted That Met QC Criteria
June 29, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Carcinoma, Squamous Cell
- Neoplasms, Squamous Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Folic Acid Antagonists
- Cisplatin
- Fluorouracil
- Raltitrexed
Other Study ID Numbers
- 2014NL-035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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