Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Nasopharyngeal Carcinoma
- Conditions
- Nasopharyngeal Neoplasms
- Interventions
- Registration Number
- NCT02360501
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy. Thus, in this study, the investigators use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.
- Detailed Description
The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy.However, the standard chemotherapy regimen has not been defined yet.Combination of cisplatin and fluracil is the commonly used regimen with tolerable toxicity. Recent studies have found that docetaxel has good efficacy on nasopharyngeal carcinoma patients, and capecitabine can be safely used instead of fluracil. Thus, in this study, we use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- stage IVA and IVB nasopharyngeal carcinoma
- at lease one measurable lesion
- receive no chemotherapy or radiotherapy before
- Eastern CooperativeOncology Group performance status of 0 to 2.
- Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)
- mismatch the inclusion criteria
- previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
- allergy to any of these three drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description treatment arm Capecitabine docetaxel 75mg/㎡,d1; cisplatin 25mg/㎡,d1-3; capecitabine 2g/㎡, d1-14. repeated every three weeks treatment arm Docetaxel docetaxel 75mg/㎡,d1; cisplatin 25mg/㎡,d1-3; capecitabine 2g/㎡, d1-14. repeated every three weeks treatment arm Cisplatin docetaxel 75mg/㎡,d1; cisplatin 25mg/㎡,d1-3; capecitabine 2g/㎡, d1-14. repeated every three weeks
- Primary Outcome Measures
Name Time Method overall response rate every 4 weeks,up to completion of treatment(approximately 6 months) overall response rate is the sum of complete response rate and partial response rate.
- Secondary Outcome Measures
Name Time Method complete response rate every 4 weeks,up to completion of treatment(approximately 6 months) 1 year overall survival rate date from diagnosis of NPC to death of any cause (up to 12 months) 1 year progression free survival rate date from diagnosis of NPC to disease progression, or death of any cause, whichever comes first （up to 12 months）. safety profiles (including hematologic toxicities and non-hematologic toxicities.) date from diagnosis of NPC to completion of study (about 6 months) including hematologic toxicities (eg.the incidence rate of neutropenia,thrombocytopenia, and anemia), and non-hematologic toxicities (eg.edema, diarrhea, hand-foot-syndrome).
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China