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TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT02940925
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
XIANG YANQUN, Sun Yat-sen University

Brief Summary:
The purpose of this study is to compare the survival and toxicity of TPC (TAXOL, DDP AND CAPECITABINE ) VS PF (cisplatin and 5-Fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for stage IVa-b nasopharyngeal carcinoma patients in endemic area.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Other: Drug: Taxol,cisplatin and capecitabine Other: Drug: Cisplatin and 5-Fluorouracil Phase 3

Detailed Description:
This is a prospective, parallel, randomized, open labeled, multicenter phase III clinical trial to compare the survival and toxicity of TPC VS PF as induction chemotherapy combined with CCRT for stage IVa-b nasopharyngeal carcinoma patients in endemic area.The primary endpoint is failure free survival (FFS).The secondary endpoints are overall survival(OS),progression-free survival(PFS), local-regionally relapse free survival(LRFS), distant metastasis free survival(DMFS)and toxicities.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma, a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial
Study Start Date : September 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug: Taxol,cisplatin and capecitabine
Taxol, cisplatin and capecitabine as induction chemotherapy (IC) combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy |(CCRT).
Other: Drug: Taxol,cisplatin and capecitabine
Taxol, cisplatin and capecitabine as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

Active Comparator: Drug: Cisplatin and 5-Fluorouracil
Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
Other: Drug: Cisplatin and 5-Fluorouracil
Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.




Primary Outcome Measures :
  1. Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause [ Time Frame: up to 5 years ]

Secondary Outcome Measures :
  1. Overall survival calculated from randomisation to death from any cause [ Time Frame: up to 5 years ]
  2. Progression free survival calculated from randomisation to disease progression or death from any cause [ Time Frame: up to 5 years ]
  3. Local-regionally relapse free survival calculated from randomisation to locoregional failure [ Time Frame: up to 5 years ]
  4. Distant metastasis free survival calculated from randomisation to distant failure [ Time Frame: up to 5 years ]
  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: up to 5 years ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • WHO II or III pathological type
  • stage Ⅳa or Ⅳb (UICC 7th edition)
  • no anticancer treatment before
  • no malignant history
  • both gender, 18-60 years old
  • enough liver function: TBIL≤ULN;AST/ALT≤2.5×ULN;ALP≤5×ULN
  • enough kidney function: Clcr≥80 mL/min
  • enough hemo: ANC≥2×109/L, PLT≥100×109/L and HB≥9g/dL
  • no sever heart, lung disfunction
  • PS≤2

Exclusion Criteria:

  • previous anticancer treatment
  • distant metastasis
  • pregnant or breasting female
  • can not access to followup
  • enrolled in other therapeutic clinical trial
  • sever infection and internal disease
  • sever disfunction of heart, lung, kidney, liver, etc
  • TBIL>ULN;AST/ALT>2.5×ULN;ALP>5×ULN
  • with factors that will affect the administration, distribution,metabolism or evacuation.
  • using immunosuppressive agents after organ transplantation
  • other malignant history

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): NCT02940925


Contacts
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Contact: Weixiong Xia +86-18520415699
Contact: Xing Lv +86-15920182400

Locations
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China, Guangdong
SunYat-senU Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Yanqun Xiang, MD    +86-18666096623    xiangyq@sysucc.org.cn   
Contact: Weixiong Xia, MD    +86-18520415699    xiawx@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Chair: Yanqun Xiang Sun Yat-sen University
Principal Investigator: Taize Yuan Cancer Center of Guangzhou medical school
Principal Investigator: Yunxiang He Xiangya Hospital

Publications:

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Responsible Party: XIANG YANQUN, PROFESSOR, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02940925     History of Changes
Other Study ID Numbers: 20160049
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The diagnosis, treatment regimen, toxicity and followup data will be shared once every year through email, phone or meeting.

Keywords provided by XIANG YANQUN, Sun Yat-sen University:
Nasopharyngeal carcinoma
induction chemotherapy

Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Capecitabine
Fluorouracil
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators