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TPF Induction Chemotherapy vs PF Adjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC

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ClinicalTrials.gov Identifier: NCT03574324
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Feng Jing, Guiyang Medical University

Brief Summary:
Through randomized controlled phase III multicenter clinical trials, TPF induction chemotherapy vs. PF regimen adjuvant chemotherapy concurrently Radiotherapy and chemotherapy for the treatment of locally advanced nasopharyngeal carcinoma: the efficacy, toxicity and quality of life, and further improvement Survival rate and improve the quality of life.

Condition or disease Intervention/treatment Phase
Locally Advanced Nasopharyngeal Carcinoma Drug: TPF+CCRT Drug: CCRT+PF Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Controlled Phase III Clinical Trial of TPF Induction Chemotherapy Versus PF Adjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
Actual Study Start Date : May 24, 2018
Estimated Primary Completion Date : May 24, 2023
Estimated Study Completion Date : May 24, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TPF+CCRT
TPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy
Drug: TPF+CCRT
Patients receive Neoadjuvant Docetaxel (75mg/m2 on day1 03:30-04:30) and cisplatin (75mg/m2 on day 1-5 10:00-22:00) and 5-FU(750mg/m2 on day 1-5 22:00-10:00) every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 10:00-22:00)every 21 days for three cycles during radiotherapy
Other Name: Experimental group

CCRE+PF
Cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy followed by PF adjuvant chemotherapy
Drug: CCRT+PF
Patients receive concurrent cisplatin (100mg/m2 on day1 10:00-22:00)every 21 days for three cycles during radiotherapy followed by adjuvant cisplatin (80mg/m2 on day 1-5 10:00-22:00) and 5-FU(800mg/m2 on day 1-5 22:00-10:00) every 21days for three cycles
Other Name: Control group




Primary Outcome Measures :
  1. Progress-free survival(PFS) [ Time Frame: 3 years ]
    Progress-free survival(year) is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.


Secondary Outcome Measures :
  1. Overall survival(OS) [ Time Frame: 3 years ]
    The OS(year) was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.

  2. Locoregional failure-free survival(LRFS) [ Time Frame: 3 years ]
    The LRFS(year) is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.

  3. Distant metastasis-free survival(DMFS) [ Time Frame: 3 years ]
    The DMFS(year) is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.

  4. Overall response rate [ Time Frame: 12 weeks after completion of concurrent chemoradiotherapy ]
    Tumour response(CR/PR/SD/PD) was classified according to RECIST v1.1

  5. Incidence of acute and late toxicity [ Time Frame: 3 years ]
    Incidence of acute toxicity(Grade1/2/3/4) is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
  2. Clinical staged as III,IVa(according to the American Joint Committee on Cancer(AJCC) 7th edition)
  3. Fertility women should ensure contraception during entry into the study.
  4. Age 18-69 years old.
  5. Karnofsky scale(KPS)≥70.
  6. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
  7. Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
  8. Adequate renal function: creatinine clearance ≥60 ml/min.
  9. Patients must be informed of the investigational nature of this study and give written informed consent

Exclusion Criteria:

  1. With distant metastasis.
  2. who had received prior chemotherapy or radiotherapy.
  3. patients have physical or mental illness, and by researchers believe that patients 4.can not be completely or fully understood in this study possible complications.

5.pregnancy (via the urine or serum β-HCG test confirmed) or during lactation. 6.serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.


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): NCT03574324


Contacts
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Contact: Feng Jin, Bachelor 0851-86512802 jinf8865@yeah.net
Contact: Yuanyuan Li, Master 0851-86512802 lilyuanyuan@qq.com

Locations
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China, 贵州省
Cancer Hospital of Guizhou Medical University Recruiting
Guiyang, 贵州省, China, 550000
Contact: Yuanyuan Li, master    085186512802    lilyuanyuan@qq.com   
Sub-Investigator: Feng Jin, Bachelor         
Sub-Investigator: Weili Wu, Master         
Sub-Investigator: Jinhua Long, Master         
Sub-Investigator: Xiuling Luo, Bachelor         
Sub-Investigator: Xiuyun Gong, Bachelor         
Sub-Investigator: Hang Jiang, Master         
Sub-Investigator: Yanfang Cen, Bachelor         
Sponsors and Collaborators
Guiyang Medical University
Investigators
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Principal Investigator: Yuanyuan Li, Master Guizhou Provincial Cancer Hospital
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Responsible Party: Feng Jing, Head and neck cancer director, chief researcher, clinical professor, Guiyang Medical University
ClinicalTrials.gov Identifier: NCT03574324    
Other Study ID Numbers: 20180602
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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