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

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ClinicalTrials.gov Identifier: NCT02143388
Recruitment Status : Completed
First Posted : May 21, 2014
Last Update Posted : August 31, 2022
Sponsor:
Collaborators:
Jiangxi Provincial Cancer Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
National Cancer Centre, Singapore
Information provided by (Responsible Party):
Zhao Chong, Sun Yat-sen University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Local Advanced High Risk Nasopharyngeal Carcinoma Drug: IMRT combine with cisplatin concurrent chemotherapy Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial
Actual Study Start Date : March 31, 2014
Actual Primary Completion Date : July 27, 2018
Actual Study Completion Date : August 5, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Concurrent chemoradiation + adjuvant chemotherapy
IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
 Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
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.
Active Comparator: Concurrent chemoradiation
IMRT combine with cisplatin concurrent chemotherapy
 Drug: IMRT combine with cisplatin concurrent chemotherapy
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02143388


Locations
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China, Guangdong
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Sponsors and Collaborators
Zhao Chong
Jiangxi Provincial Cancer Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
National Cancer Centre, Singapore
Investigators
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Principal Investigator: zhao chong, M.D Sun Yat-sen University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zhao Chong, MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02143388    
Other Study ID Numbers: CCRT-AC-LAHR-NPC
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022
Keywords provided by Zhao Chong, Sun Yat-sen University:
Local advanced
high risk
nasopharyngeal carcinoma
Additional relevant MeSH terms:
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Carcinoma
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
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Capecitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action