Brief Title
Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal Cancer
Official Title
Phase II Trial of Docetaxel-Cisplatin Neoadjuvant Chemotherapy Followed by Concurrent Radiotherapy With Cetuximab or Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
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.
Detailed Description
Although concurrent chemoradiation is the standard treatment modality for locally advanced
nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment
related toxicities have become an obstacle to be overcome. A phase Ⅱ study conducted by Hui
et al. showed that neoadjuvant docetaxel-cisplatin (TP) chemotherapy followed by concurrent
chemoradiotherapy was superior to the standard concomitant chemoradiation in terms of the
3-year OS without significantly exacerbating the acute toxicities. Moreover, Bonner et al.
demonstrated that RT with concurrent Cetuximab significantly improved the 5-year OS and did
not increase the treatment induced toxicities when compared with RT alone. Therefore, we
initiated this study to compare the efficacy and toxicity of the two regimens, neoadjuvant
chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin for
locally advanced NPC.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-free survival
Secondary Outcome
Overall survival
Condition
Nasopharyngeal Carcinoma
Intervention
Cetuximab
Study Arms / Comparison Groups
cisplatin-radiotherapy (CRT)
Description: The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent weekly cisplatin and radiotherapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
46
Start Date
August 2010
Completion Date
August 2014
Primary Completion Date
August 2014
Eligibility Criteria
Inclusion Criteria:
1. Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)
2. Stage Ⅲ-ⅣB disease (AJCC/UICC 2009)
3. ECOG performance status of 0-1
4. Life expectancy of more than 6 months
5. Signed written informed consent
6. 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
Exclusion Criteria:
1. Evidence of distant metastasis
2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior
radiotherapy to the head and neck region
3. Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous
basal cell carcinoma
4. Pregnant or breast-feeding females, or females and males of childbearing potential not
taking adequate contraceptive measures
5. 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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Guopei Zhu, M.D., ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01614938
Organization ID
HN201002
Responsible Party
Principal Investigator
Study Sponsor
Fudan University
Study Sponsor
Guopei Zhu, M.D., Principal Investigator, Fudan University
Verification Date
June 2012