- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02301208
Weekly Cisplatin or Nedaplatin Concurrent With Intensity-modulated Radiation Therapy in Nasopharyngeal Carcinoma (NPC-RCT-WCRT)
December 5, 2014 updated by: He Xia
A Randomized Phase III Study of Concurrent Weekly Nedaplatin or Cisplatin With IMRT in NPC Patients
This is a randomized Phase III study to evaluate efficancy of weekly cisplatin or nedaplatin concurrent with Intensity-modulated radiation therapy in Nasopharyngeal Carcinoma (NPC).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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: Li Yin, M.D. Ph.D.
- Phone Number: +8613913909043
- Email: yinli7878@sina.com
Study Contact Backup
- Name: Pengwei Yan, M.M.
- Phone Number: +8613815888775
- Email: 179032794@qq.com
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 NPC patients
- T1-2N1-3M0 or T3-4NxM0
- 18-70 years old
- with MRI examinations
- ECOG ≤ 2
- With written consent
Exclusion Criteria:
- With a second cancer
- Pregnancy
- With other severe diseases (blood,liver ,kidney or heart diseases)
- Could not be staged properly
- 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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Low dose cisplatin arm
concurrent chemotherapy: cisplatin 20mg/m2,weekly,for 6 cycles during radiotherapy
|
Cisplatin combine with IMRT
Other Names:
|
Active Comparator: High dose cisplatin arm
concurrent chemotherapy: cisplatin 30mg/m2,weekly,for 6 cycles during radiotherapy
|
Cisplatin combine with IMRT
Other Names:
|
Experimental: Low dose nedaplatin arm
concurrent chemotherapy: nedaplatin 20mg/m2,weekly,for 6 cycles during radiotherapy
|
Nedaplatin combine with IMRT
Other Names:
|
Experimental: High dose nedaplatin arm
concurrent chemotherapy: nedaplatin 30mg/m2,weekly,for 6 cycles during radiotherapy
|
Nedaplatin combine with IMRT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate
Time Frame: 2 years
|
2 years
|
Progress-free survival
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 2 years
|
2 years
|
Tumor response
Time Frame: radiotherapy in 2 week、4 week、7 week
|
radiotherapy in 2 week、4 week、7 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 1, 2014
Primary Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
November 19, 2014
First Submitted That Met QC Criteria
November 21, 2014
First Posted (Estimate)
November 25, 2014
Study Record Updates
Last Update Posted (Estimate)
December 8, 2014
Last Update Submitted That Met QC Criteria
December 5, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Antineoplastic Agents
- Nedaplatin
Other Study ID Numbers
- JiangsuCIH
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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