Overview

This trial is active, not recruiting.

Condition nasopharyngeal carcinoma
Treatments cetuximab, cisplatin, docetaxel, intensity-modulated radiotherapy
Phase phase 2
Target EGFR
Sponsor Fudan University
Start date August 2010
End date August 2014
Trial size 46 participants
Trial identifier NCT01614938, HN201002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent weekly cisplatin and radiotherapy
docetaxel Taxotere
2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1
intensity-modulated radiotherapy IMRT
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
cisplatin Platinol
2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3, then 6 cycles of concomitant chemotherapy every week with cisplatin 30 mg/m2 D1
(Experimental)
The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent cetuximab and radiotherapy
cetuximab Erbitux
400 mg/m2 initial dose before radiation, then 250 mg/m2 weekly during radiation
cisplatin Platinol
2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3
docetaxel Taxotere
2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1
intensity-modulated radiotherapy IMRT
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

Primary Outcomes

Measure
Progression-free survival
time frame: up to 3 years

Secondary Outcomes

Measure
Overall survival
time frame: up to 3 years
Locoregional recurrence-free survival
time frame: up to 3 years
Distant metastasis-free survival
time frame: up to 3 years
Number of participants with hematologic toxicity events occurred during two cycles of neoadjuvant chemotherapy according to CTCAE v4.0
time frame: 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
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Number of participants with late toxicities (hematologic toxicity events, dysphagia, acne-like rash) occurred from 3 months after completion of radiotherapy to last follow-up visit according to CTCAE v4.0
time frame: Every 3 months during the first 2 years, then every 6 months during year 3 after completion of radiotherapy
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) at 3 months after completion of radiotherapy
time frame: At 3 months after completion of radiotherapy

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Phase II Trial of Docetaxel-Cisplatin Neoadjuvant Chemotherapy Followed by Concurrent Radiotherapy With Cetuximab or Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
Principal investigator Guopei Zhu, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Fudan University.