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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 : Active, not recruiting
First Posted : May 21, 2014
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
First People's Hospital of Foshan
Guangzhou General Hospital of Guangzhou Military Command
Information provided by (Responsible Party):
Zhao Chong, Sun Yat-sen University

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 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : May 2014
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 18 months ]
    Defined as the time in months from first dose of cisplatin until PD is observed or death occurs due to 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. Three-year locoregional relapse free survival rate [ Time Frame: 3 years ]
  2. Three-year distance metastasis free survival rate [ Time Frame: 3 years ]
  3. Three-year overall survival rate [ Time Frame: 3 years ]
  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.



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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

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
First People's Hospital of Foshan
Guangzhou General Hospital of Guangzhou Military Command
Investigators
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Principal Investigator: zhao chong, M.D Sun Yat-sen University

Additional Information:
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Responsible Party: Zhao Chong, MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02143388     History of Changes
Other Study ID Numbers: CCRT-AC-LAHR-NPC
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
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