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GP Induction Chemotherapy us TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC

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ClinicalTrials.gov Identifier: NCT03604965
Recruitment Status : Unknown
Verified July 2018 by Feng Jing, Guiyang Medical University.
Recruitment status was:  Recruiting
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Feng Jing, Guiyang Medical University

Brief Summary:
Through randomized controlled phase III multicenter clinical trials, GP induction chemotherapy vs TPF regimen adjuvant chemotherapy combined with DDP concurrent chemoradiotherapy 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: GP+CCRT Drug: TPF+CCRT Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 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 GP Induction Chemotherapy With TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
Actual Study Start Date : July 21, 2018
Estimated Primary Completion Date : July 21, 2020
Estimated Study Completion Date : July 21, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GP+CCRT
GP neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy
Drug: GP+CCRT
Patients receive Neoadjuvant gemcitabine (1000mg/m2 on day1 and day8 ) and cisplatin (80mg/m2 on day1)every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 or day2)every 21 days for three cycles during radiotherapy
Other Name: Experimental group

Active Comparator: 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 or day2)every 21 days for three cycles during radiotherapy
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: 3 years ]
    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. In the newly diagnosed patient, no radiotherapy or chemotherapy was performed before the start of the clinical trial.
  2. Pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III).
  3. III, IVa patients (AJCC version 8 staging).
  4. Male or non-pregnant women.
  5. Age ≥ 18 and < 70 years old.
  6. Functional status: Karnofsky scale (KPS) > 70.
  7. White blood cells (WBC) ≥ 4 × 109.

    /L, hemoglobin (HGB) ≥ 90 g / L, platelets (PLT) ≥ 100 × 109 / L (or within the normal range of the laboratory)

  8. Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN.
  9. Renal function: creatinine clearance ≥ 60ml / min or serum creatinine ≤ 1.5 × ULN.
  10. The patient has signed an informed consent form.

Exclusion Criteria:

  1. The pathological type is WHO's keratinized squamous cell carcinoma or basal squamous cell carcinoma.
  2. Age ≥ 70 years old or < 18 years old.
  3. Treatment is palliative.
  4. Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer.
  5. Women during pregnancy or lactation (pregnant women should be considered for women of childbearing age; Effective contraception).
  6. Previously received radiation therapy (if non-melanoma skin cancer and previous lesions are outside the target area of radiotherapy, then except).
  7. Primary and cervical metastatic lesions received chemotherapy or surgery (except for diagnostic treatment).
  8. With other serious diseases, it may bring greater risk or affect the compliance of the test. For example: no need for treatment Stable heart disease, kidney disease, chronic hepatitis, control of unsatisfactory diabetes (fasting blood glucose > 1.5 × ULN),And mental illness.

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): NCT03604965


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: 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: NCT03604965    
Other Study ID Numbers: 201805043
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 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