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NCT01712919 Clinical Trial

Chemoradiation Plus Weekly c225 Against Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)

Nasopharyngeal Carcinoma Clinical Trial

Official title:
IMRT With Concurrent Chemotherapy and Cetuximab Against Locoregionally Advanced NPC: a Phase 1 Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01712919
Other study ID # LA-chemoR-c225
Secondary ID JSCC-SACT-01
Status Completed
Phase Phase 1/Phase 2
First received October 18, 2012
Last updated March 21, 2014
Start date May 2010
Est. completion date March 2014

Study information
Verified date March 2014
Source Jiangsu Cancer Institute & Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and efficacy of this new regimen.

Recruitment information / eligibility
Status Completed
Enrollment 61
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Pathologically confirmed untreated NPC patients

- locoregionally advanced (T3-4 or N2-3 M0)

- 18-65 years

- with MRI examinations

- ECOG = 2

- With written consent

Exclusion Criteria:

- Without a second cancer

- Pregnancy

- With other severe diseases (blood,liver ,kidney or heart diseases)

- Could not be staged properly

- Without written consent

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Radiation:
• Intensity-modulated radiotherapy
Patients will be given intensity-modulated radiotherapy(IMRT)
Drug:
• Concurrent chemotherapy with paclitaxel and nedaplatin
Patients will be given 2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin
Biological:
• Cetuximab
Patients will be given cetuximab weekly during radiation therapy

Locations
Country Name City State
China Jiangsu Cancer Hospital Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Jiangsu Cancer Institute & Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Other local-relapse free survival 24 months No
Primary Number of Participants with Adverse Events as a Measure of Safety 6 months Yes
Primary Number of Participants with Adverse Events as a Measure of Safety and tolerability 6 months Yes
Secondary Progress free survival 24 months No
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