Clinical trial NCT02360501: Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Nasopharyngeal Carcinoma
Official title: Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Locally Advanced or Metastatic Nasopharyngeal Carcinoma: a Prospective, Phase 2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Neoplasms
Keywords: nasopharyngeal carcinoma
induction chemotherapy
docetaxel
xeloda
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: overall response rate
timeFrame: every 4 weeks,up to completion of treatment(approximately 6 months)
Secondary outcomes:
measure: complete response rate
timeFrame: every 4 weeks,up to completion of treatment(approximately 6 months)
measure: 1 year progression free survival rate
timeFrame: date from diagnosis of NPC to disease progression, or death of any cause, whichever comes first （up to 12 months）.
measure: 1 year overall survival rate
timeFrame: date from diagnosis of NPC to death of any cause (up to 12 months)
measure: safety profiles (including hematologic toxicities and non-hematologic toxicities.)
timeFrame: date from diagnosis of NPC to completion of study (about 6 months)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Liang Wang, DOCTOR
role: PRINCIPAL_INVESTIGATOR
References: