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NCT Number: NCT02143388

Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial

This is an randomized controlled, multicenter clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.

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Key information

Conditions

Local Advanced High Risk Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Carcinoma 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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
  • Clinical stage III~IVb(UICC 7th)
  • Meet at least one factor below :1 primary tumor SUVmax>10 in 18F-FDG PET/CT;2 primary tumor volume>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter>4cm; 4 T4N2M0; 5 T1-4N3M0;6 EBV-DNA>2×10E4 copy/l
  • Range from 18～70 years old
  • WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
  • ALT or AST < 2.5×ULN、bilirubin < 1.5×ULN
  • OSerum creatinine < 1.5×ULN

Exclusion criteria

  • Central nervous system metastases
  • Suitable for local treatment
  • Uncontrolled seizure disorder or other serious neurologic disease
  • Clinically significant cardiac or respiratory disease
  • Drug or alcohol addition
  • Do not have full capacity for civil acts
  • Severe complication, active infection
  • Concurrent immunotherapy or hormone therapy for other diseases
  • Pregnancy or lactation

Treatment and study plan

IMRT combine with cisplatin concurrent chemotherapy

Drug

Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT.

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Drug

Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles.

Primary outcomes

  1. Failure free survival

    Time frame: 3-year

    Defined as the time from date of recruitment to documented relapse or death from any cause.

Secondary outcomes

  1. Acute Toxicity

    Time frame: 18 months

    To evaluate the acute toxicity with CTC 3.0 when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.

Other outcomes

  1. Locoregional relapse free survival

    Time frame: 3-year

    Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.

  2. Distance metastasis free survival

    Time frame: 3-year

    Defined as the time from date of recruitment to documented distant metastatic recurrence or death from any cause.

  3. Overall survival rate

    Time frame: 3-year

    Defined as the time from date of recruitment to death from any cause.

  4. Late Toxicity

    Time frame: 3 years

    To evaluate the late toxicity with the RTOG/EORTC criterion when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.

Sponsors and collaborators

Lead sponsor

Zhao Chong

Other

Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Jiangxi Provincial Cancer Hospital
  • National Cancer Centre, Singapore

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2022
First posted
May 21, 2014
Registry last updated
Aug 31, 2022

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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