Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal Cancer
Phase II Trial of Docetaxel-Cisplatin Neoadjuvant Chemotherapy Followed by Concurrent Radiotherapy With Cetuximab or Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
1 other identifier
interventional
46
1 country
1
Brief Summary
The purpose of this study is to compare the efficacy and toxicity of docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin in locally advanced nasopharyngeal carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 5, 2012
CompletedFirst Posted
Study publicly available on registry
June 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedJune 8, 2012
June 1, 2012
4 years
June 5, 2012
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
The time from date of randomization until date of first documented disease progression or death from any cause, assessed up to 3 years.
up to 3 years
Secondary Outcomes (8)
Overall survival
up to 3 years
Locoregional recurrence-free survival
up to 3 years
Distant metastasis-free survival
up to 3 years
Number of participants with hematologic toxicity events occurred during two cycles of neoadjuvant chemotherapy according to CTCAE v4.0
1, 2, 3 weeks post-dose
Number of participants with acute toxicities (hematologic toxicity events, oral mucositis, acne-like rash) occurred during the concurrent treatment according to CTCAE v4.0
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
- +3 more secondary outcomes
Study Arms (2)
cisplatin-radiotherapy (CRT)
ACTIVE COMPARATORThe arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent weekly cisplatin and radiotherapy
cetuximab-radiotherapy (ERT)
EXPERIMENTALThe arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent cetuximab and radiotherapy
Interventions
400 mg/m2 initial dose before radiation, then 250 mg/m2 weekly during radiation
2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3
2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1
a total dose of 66-70.4Gy in 30-32 fractions over 6-6.5 weeks planned to be delivered to the PTV of gross tumor
Eligibility Criteria
You may qualify if:
- Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)
- Stage Ⅲ-ⅣB disease (AJCC/UICC 2009)
- ECOG performance status of 0-1
- Life expectancy of more than 6 months
- Signed written informed consent
- Adequate organ function including the following:
- Absolute neutrophil count (ANC) \>= 1.5 \* 109/l
- Platelets count \>= 100 \* 109/l
- Hemoglobin \>= 10 g/dl
- AST and ALT \<= 2.5 times institutional upper limit of normal (ULN)
- Total bilirubin \<= 1.5 times institutional ULN
- Creatinine clearance \>= 50 ml/min
- Serum creatine \<= 1 times ULN
You may not qualify if:
- Evidence of distant metastasis
- Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
- Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
Xu T, Liu Y, Dou S, Li F, Guan X, Zhu G. Weekly cetuximab concurrent with IMRT aggravated radiation-induced oral mucositis in locally advanced nasopharyngeal carcinoma: Results of a randomized phase II study. Oral Oncol. 2015 Sep;51(9):875-9. doi: 10.1016/j.oraloncology.2015.06.008. Epub 2015 Jul 7.
PMID: 26163437DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guopei Zhu, M.D.
Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Associated Professor
Study Record Dates
First Submitted
June 5, 2012
First Posted
June 8, 2012
Study Start
August 1, 2010
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
June 8, 2012
Record last verified: 2012-06