Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Nasopharyngeal Carcinoma

Sun Yat-sen University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasopharyngeal Neoplasms

Interventions

DocetaxelDRUG

75mg/㎡,d1

CisplatinDRUG

25mg/㎡,d1-3

CapecitabineDRUG

2000mg/㎡,d1-14

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

overall response rate

overall response rate is the sum of complete response rate and partial response rate.

Time frame: every 4 weeks,up to completion of treatment(approximately 6 months)

Secondary Outcomes

complete response rate

Time frame: every 4 weeks,up to completion of treatment(approximately 6 months)

1 year progression free survival rate

Time frame: 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

Time frame: date from diagnosis of NPC to death of any cause (up to 12 months)

safety profiles (including hematologic toxicities and non-hematologic toxicities.)

including hematologic toxicities (eg.the incidence rate of neutropenia,thrombocytopenia, and anemia), and non-hematologic toxicities (eg.edema, diarrhea, hand-foot-syndrome).

Time frame: date from diagnosis of NPC to completion of study (about 6 months)

Data from ClinicalTrials.gov

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