Back to resultsCombination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Neoplasms
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Cisplatin
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Neoplasms focused on measuring nasopharyngeal carcinoma, induction chemotherapy, docetaxel, xeloda
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
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment arm
Arm Description
docetaxel 75mg/㎡,d1; cisplatin 25mg/㎡,d1-3; capecitabine 2g/㎡, d1-14. repeated every three weeks
Outcomes
Primary Outcome Measures
overall response rate
overall response rate is the sum of complete response rate and partial response rate.
Secondary Outcome Measures
complete response rate
1 year progression free survival rate
1 year overall survival rate
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).
Full Information
NCT ID
NCT02360501
First Posted
February 3, 2015
Last Updated
April 18, 2016
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02360501
Brief Title
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
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Neoplasms
Keywords
nasopharyngeal carcinoma, induction chemotherapy, docetaxel, xeloda
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment arm
Arm Type
Experimental
Arm Description
docetaxel 75mg/㎡,d1; cisplatin 25mg/㎡,d1-3; capecitabine 2g/㎡, d1-14. repeated every three weeks
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
75mg/㎡,d1
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
25mg/㎡,d1-3
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
xeloda
Intervention Description
2000mg/㎡,d1-14
Primary Outcome Measure Information:
Title
overall response rate
Description
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 Outcome Measure Information:
Title
complete response rate
Time Frame
every 4 weeks,up to completion of treatment(approximately 6 months)
Title
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）.
Title
1 year overall survival rate
Time Frame
date from diagnosis of NPC to death of any cause (up to 12 months)
Title
safety profiles (including hematologic toxicities and non-hematologic toxicities.)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Wang, DOCTOR
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Learn more about this trial
Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Nasopharyngeal Carcinoma
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