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NCT02301208 Clinical Trial

Weekly Cisplatin or Nedaplatin Concurrent With Intensity-modulated Radiation Therapy in Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

— NPC-RCT-WCRT  

Official title:
A Randomized Phase III Study of Concurrent Weekly Nedaplatin or Cisplatin With IMRT in NPC Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02301208
Other study ID # JiangsuCIH
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received November 19, 2014
Last updated December 5, 2014
Start date December 2014

Study information
Verified date December 2014
Source Jiangsu Cancer Institute & Hospital
Contact Li Yin, M.D. Ph.D.
Phone +8613913909043
Email yinli7878@sina.com
Is FDA regulated No
Health authority Jiangsu Provincial Commission of Health and Family Planning:China
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Nedaplatin
Nedaplatin combine with IMRT
• Cisplatin
Cisplatin combine with IMRT

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
He Xia

Outcome
Type Measure Description Time frame Safety issue
Primary Response rate 2 years Yes
Primary Progress-free survival 2 years Yes
Secondary Tumor response radiotherapy in 2 week?4 week?7 week Yes
Secondary Overall survival 2 years Yes
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