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

Primary Purpose

Locally Advanced Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
GP+CCRT
TPF+CCRT
Sponsored by
Guiyang Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Hospital of Guizhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GP+CCRT

TPF+CCRT

Arm Description

GP neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy

TPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy

Outcomes

Primary Outcome Measures

Progress-free survival(PFS)
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

Overall survival(OS)
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.
Locoregional failure-free survival(LRFS)
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.
Distant metastasis-free survival(DMFS)
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.
Overall response rate
Tumour response(CR/PR/SD/PD) was classified according to RECIST v1.1
Incidence of acute and late toxicity
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

Full Information

First Posted
July 21, 2018
Last Updated
July 21, 2018
Sponsor
Guiyang Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03604965
Brief Title
GP Induction Chemotherapy us TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 21, 2018 (Actual)
Primary Completion Date
July 21, 2020 (Anticipated)
Study Completion Date
July 21, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guiyang Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GP+CCRT
Arm Type
Experimental
Arm Description
GP neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy
Arm Title
TPF+CCRT
Arm Type
Active Comparator
Arm Description
TPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy
Intervention Type
Drug
Intervention Name(s)
GP+CCRT
Other Intervention Name(s)
Experimental group
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
TPF+CCRT
Other Intervention Name(s)
Control group
Intervention Description
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
Primary Outcome Measure Information:
Title
Progress-free survival(PFS)
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival(OS)
Description
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.
Time Frame
3 years
Title
Locoregional failure-free survival(LRFS)
Description
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.
Time Frame
3 years
Title
Distant metastasis-free survival(DMFS)
Description
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.
Time Frame
3 years
Title
Overall response rate
Description
Tumour response(CR/PR/SD/PD) was classified according to RECIST v1.1
Time Frame
3 years
Title
Incidence of acute and late toxicity
Description
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
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In the newly diagnosed patient, no radiotherapy or chemotherapy was performed before the start of the clinical trial. Pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III). III, IVa patients (AJCC version 8 staging). Male or non-pregnant women. Age ≥ 18 and < 70 years old. Functional status: Karnofsky scale (KPS) > 70. 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) Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN. Renal function: creatinine clearance ≥ 60ml / min or serum creatinine ≤ 1.5 × ULN. The patient has signed an informed consent form. Exclusion Criteria: The pathological type is WHO's keratinized squamous cell carcinoma or basal squamous cell carcinoma. Age ≥ 70 years old or < 18 years old. Treatment is palliative. Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer. Women during pregnancy or lactation (pregnant women should be considered for women of childbearing age; Effective contraception). Previously received radiation therapy (if non-melanoma skin cancer and previous lesions are outside the target area of radiotherapy, then except). Primary and cervical metastatic lesions received chemotherapy or surgery (except for diagnostic treatment). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Jin, Bachelor
Phone
0851-86512802
Email
jinf8865@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanyuan Li, Master
Phone
0851-86512802
Email
lilyuanyuan@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanyuan Li, Master
Organizational Affiliation
Guizhou Provincial Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital of Guizhou Medical University
City
Guiyang
State/Province
贵州省
ZIP/Postal Code
550000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanyuan Li, master
Phone
085186512802
Email
lilyuanyuan@qq.com
First Name & Middle Initial & Last Name & Degree
Feng Jin, Bachelor
First Name & Middle Initial & Last Name & Degree
Weili Wu, Master
First Name & Middle Initial & Last Name & Degree
Jinhua Long, Master
First Name & Middle Initial & Last Name & Degree
Xiuling Luo, Bachelor
First Name & Middle Initial & Last Name & Degree
Xiuyun Gong, Bachelor
First Name & Middle Initial & Last Name & Degree
Yanfang Cen, Bachelor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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