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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 â…¡ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cisplatin-radiotherapy (CRT) | Active Comparator | The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent weekly cisplatin and radiotherapy |
|
| cetuximab-radiotherapy (ERT) | Experimental | The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent cetuximab and radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | 400 mg/m2 initial dose before radiation, then 250 mg/m2 weekly during radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time from date of randomization until date of death due to any cause, assessed up to 3 years. | 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. |
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Inclusion Criteria:
Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)
Stage â…¢-â…£B 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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guopei Zhu, M.D. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26163437 | Derived | 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. |
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| Cisplatin | Drug | 2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3 |
|
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| Docetaxel | Drug | 2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1 |
|
|
| Intensity-modulated radiotherapy | Radiation | 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 |
|
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| Cisplatin | Drug | 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 |
|
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| 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. | 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 |
| 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 | 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 | QoL score will be documented on each weekend during the course of radiotherapy | 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 | At 3 months after completion of radiotherapy |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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