Clinical trial NCT01614938: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
Locally advanced
Cetuximab
Weekly cisplatin chemotherapy
Intensity-modulated radiotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free survival
timeFrame: up to 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: up to 3 years
measure: Locoregional recurrence-free survival
timeFrame: up to 3 years
measure: Distant metastasis-free survival
timeFrame: up to 3 years
measure: Number of participants with hematologic toxicity events occurred during two cycles of neoadjuvant chemotherapy according to CTCAE v4.0
timeFrame: 1, 2, 3 weeks post-dose
measure: Number of participants with acute toxicities (hematologic toxicity events, oral mucositis, acne-like rash) occurred during the concurrent treatment according to CTCAE v4.0
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: 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
timeFrame: Every 3 months during the first 2 years, then every 6 months during year 3 after completion of radiotherapy
measure: 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
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: 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
timeFrame: At 3 months after completion of radiotherapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Guopei Zhu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.