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

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ClinicalTrials.gov Identifier: NCT02360501
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Liang Wang, 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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Neoplasms Drug: Docetaxel Drug: Cisplatin Drug: Capecitabine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2008
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: treatment arm
docetaxel 75mg/㎡,d1; cisplatin 25mg/㎡,d1-3; capecitabine 2g/㎡, d1-14. repeated every three weeks
Drug: Docetaxel
75mg/㎡,d1
Other Name: Taxotere

Drug: Cisplatin
25mg/㎡,d1-3

Drug: Capecitabine
2000mg/㎡,d1-14
Other Name: xeloda




Primary Outcome Measures :
  1. overall response rate [ Time Frame: 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 :
  1. complete response rate [ Time Frame: every 4 weeks,up to completion of treatment(approximately 6 months) ]
  2. 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). ]
  3. 1 year overall survival rate [ Time Frame: date from diagnosis of NPC to death of any cause (up to 12 months) ]
  4. safety profiles (including hematologic toxicities and non-hematologic toxicities.) [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360501


Locations
China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Liang Wang, DOCTOR Sun Yat-sen University

Responsible Party: Liang Wang, Doctor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02360501     History of Changes
Other Study ID Numbers: DCX in NPC
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

Keywords provided by Liang Wang, Sun Yat-sen University:
nasopharyngeal carcinoma
induction chemotherapy
docetaxel
xeloda

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Docetaxel
Cisplatin
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites