Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal Cancer

Fudan University46 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasopharyngeal Carcinoma

Interventions

CetuximabDRUG

400 mg/m2 initial dose before radiation, then 250 mg/m2 weekly during radiation

CisplatinDRUG

2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3

DocetaxelDRUG

2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: up to 3 years

Secondary Outcomes

Overall survival

The time from date of randomization until date of death due to any cause, assessed up to 3 years.

Time frame: up to 3 years

Locoregional recurrence-free survival

The time from date of randomization until date of first documented disease recurrence at a locoregional site, assessed up to 3 years.

Time frame: up to 3 years

Distant metastasis-free survival

The time from date of randomization until date of first documented distant metastasis, assessed up to 3 years.

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

Data from ClinicalTrials.gov

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