Nasopharyngeal Neoplasms
Conditions
Keywords
nasopharyngeal carcinoma, induction chemotherapy, docetaxel, xeloda
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.
Interventions
DRUGDocetaxel
75mg/㎡,d1
DRUGCisplatin
25mg/㎡,d1-3
DRUGCapecitabine
2000mg/㎡,d1-14
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| complete response rate | every 4 weeks,up to completion of treatment(approximately 6 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）. | — |
| 1 year overall survival rate | date from diagnosis of NPC to death of any cause (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). |
Countries
China
Outcome results
None listed