Back to resultsInduction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
A combination of Gemcitabine and cisplatin
A combination of Docetaxel, cisplatin and 5-Fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma, Induction chemotherapy, Concurrent chemoradiotherapy, Gemcitabine, Docetaxel
Eligibility Criteria
Inclusion Criteria:
- Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
- 18 years to 70 years;
- Tumor staged as T3-4N1/N2-3M0 (according to the 7th AJCC edition),
- Performance status: Karnofsky scale (KPS) > 70 (Appendix I ).
- Adequate marrow: leucocyte count > 4×109/L, neutrophil count > 2×109/L, hemoglobin > 90g/L and platelet count > 100×109/L.
- 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.
- Adequate renal function: creatinine clearance > 60 ml/min.
- Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria:
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Age > 70 or < 18.
- Treatment with palliative intent.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A combination of Gemcitabine and cisplatin
A combination of Docetaxel, cisplatin and 5-Fluorouracil
Arm Description
The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT.
The TPF regimen consists of docetaxel at a dose of 60 mg/m2/day on day 1, cisplatin 60 mg/m2 by i.v. infusion for 4 h on day 1-3, plus 5-Fluorouracil 600 mg/m2 CIV over 120 hours. The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT.
Outcomes
Primary Outcome Measures
Failure-free survival (FFS)
From the date of registration to the date of either locally, regionally or distant failure or last follow-up
Secondary Outcome Measures
Overall survival (OS)
Survival from the date of registration to the date of death or last follow-up
Loco-regional failure-free survival (LFFS)
Survival from the date of registration to the date of either locally, regional recurrence or last follow-up
Distant metastasis failure-free survival (DMFS)
Survival from the date of registration to the date of either distant metastasis or last follow-up
Acute induction chemotherapy toxicity
The side effects will be evaluated according to NCI-CTC AE V 3.0.
Full Information
NCT ID
NCT02016417
First Posted
December 15, 2013
Last Updated
April 15, 2014
Sponsor
Cancer Hospital of Guangxi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02016417
Brief Title
Induction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma
Official Title
Phase II Study Comparing Gemcitabine Plus Cisplatin to Docetaxel, Cisplatin, and Fluorouracil Induction Chemotherapy Followed by Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Hospital of Guangxi Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The present study is a randomized, control, phase II study of locally advanced nasopharyngeal carcinoma (NPC) treated with Gemcitabine plus cisplatin regimen (GP) or Docetaxel，cisplatin regimen plus 5-Fluorouracil (TPF) induction chemotherapy followed by concurrent chemoradiotherapy.
Detailed Description
Nasopharyngeal carcinoma (NPC) prevalence is reported to be highest in southern China, where an average of 80 cases per 100,000 population are reported each year. Nasopharyngeal carcinoma is both radiosensitive and chemosensitive. The National Comprehensive Cancer Network (NCCN) guidelines (version 1, 2013), have recommended use of concurrent chemoradiotherapy (CCRT) with or without adjuvant chemotherapy (AC) and induction chemotherapy (IC) followed by CCRT plus AC as standard treatment for NPC. However, it was unclear whether patients with NPC could benefit from IC. Recently, many new drugs including docetaxel and gemcitabine have been incorporated in the induction chemotherapy phase of NPC. The investigators designed the present study with induction chemotherapy follow by CCRT for locoregionally advanced NPC, comparing induction chemotherapy regime of gemcitabine plus cisplatin (GP) and docetaxel, cisplatin, and fluorouracil (TPF).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal carcinoma, Induction chemotherapy, Concurrent chemoradiotherapy, Gemcitabine, Docetaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A combination of Gemcitabine and cisplatin
Arm Type
Experimental
Arm Description
The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT.
Arm Title
A combination of Docetaxel, cisplatin and 5-Fluorouracil
Arm Type
Active Comparator
Arm Description
The TPF regimen consists of docetaxel at a dose of 60 mg/m2/day on day 1, cisplatin 60 mg/m2 by i.v. infusion for 4 h on day 1-3, plus 5-Fluorouracil 600 mg/m2 CIV over 120 hours. The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT.
Intervention Type
Drug
Intervention Name(s)
A combination of Gemcitabine and cisplatin
Other Intervention Name(s)
GP
Intervention Description
The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT.
Intervention Type
Drug
Intervention Name(s)
A combination of Docetaxel, cisplatin and 5-Fluorouracil
Other Intervention Name(s)
TPF
Intervention Description
The TPF regimen consists of docetaxel at a dose of 60 mg/m2/day on day 1, cisplatin 60 mg/m2 by i.v. infusion for 4 h on day 1-3, plus 5-Fluorouracil 600 mg/m2 CIV over 120 hours. The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT.
Primary Outcome Measure Information:
Title
Failure-free survival (FFS)
Description
From the date of registration to the date of either locally, regionally or distant failure or last follow-up
Time Frame
One year
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Survival from the date of registration to the date of death or last follow-up
Time Frame
One year
Title
Loco-regional failure-free survival (LFFS)
Description
Survival from the date of registration to the date of either locally, regional recurrence or last follow-up
Time Frame
One year
Title
Distant metastasis failure-free survival (DMFS)
Description
Survival from the date of registration to the date of either distant metastasis or last follow-up
Time Frame
One year
Title
Acute induction chemotherapy toxicity
Description
The side effects will be evaluated according to NCI-CTC AE V 3.0.
Time Frame
Two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
18 years to 70 years;
Tumor staged as T3-4N1/N2-3M0 (according to the 7th AJCC edition),
Performance status: Karnofsky scale (KPS) > 70 (Appendix I ).
Adequate marrow: leucocyte count > 4×109/L, neutrophil count > 2×109/L, hemoglobin > 90g/L and platelet count > 100×109/L.
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.
Adequate renal function: creatinine clearance > 60 ml/min.
Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria:
WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Age > 70 or < 18.
Treatment with palliative intent.
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaodong Zhu, Doctor
Phone
867715331466
Email
zhuxiaodong83@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Song Qu, Doctor
Phone
867715331466
Email
daisyqs2002@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaodong Zhu, Doctor
Organizational Affiliation
Cancer Institute of Guangxi Zhuang Autonomous Region
Official's Role
Study Chair
12. IPD Sharing Statement
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Links:
URL
http://www.gxmu.edu.cn/
Description
Guangxi Medical University
URL
http://www.nlm.nih.gov/medlineplus/cancer.html
Description
MedlinePlus related topics: Cancer
URL
http://druginfo.nlm.nih.gov/drugportal/
Description
Drug Information available for: Cisplatin, Gemcitabine, Docetaxel and Fluorouracil
URL
http://www.clinicaltrials.gov/
Description
U.S. FDA Resources
Learn more about this trial
Induction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma
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