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NCT Number: NCT02940925

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

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.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SunYat-senU

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug: Taxol,cisplatin and capecitabine

Other

Taxol, cisplatin and capecitabine as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

Drug: Cisplatin and 5-Fluorouracil

Other

Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

Primary outcomes

  1. Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause

    Time frame: up to 5 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Oct 21, 2016
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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