Back to resultsCombination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC (NPC)
Primary Purpose
Nasopharyngeal Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Inductive chemotherapy + concurrent cisplatin and IMRT
Inductive chemotherapy + IMRT
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Cisplatin, neoadjuvant chemotherapy, intensity-modulated radiation therapy, concurrent chemoradiotherapy
Eligibility Criteria
Inclusion Criteria:
- Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).
- A Karnofsky performance status of at least 80;
- Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0 Stage IVb：Any T、N3.
- Adequate marrow: a WBC ≥3.5×109 l-1; a platelet count ≥100×109 l-1; and hemoglobin levels ≥100 g/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: a creatinine clearance rate of at least 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.
- Age >65 years or <18 years.
- Distant metastasis,
- Treatment with palliative intent.
- Pregnancy or lactation.
- a history of previous radiotherapy in the nasopharyngeal region or previous chemotherapy.
- history of renal disease, unstable cardiac disease requiring treatment.
Sites / Locations
- Cancer Center,Sun Yat-sen UniversityRecruiting
- State Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IInductive chemotherapy + concurrent cisplatin and IMRT
Inductive chemotherapy + IMRT
Arm Description
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30 mg/m2，on day 1) repeated every weeks for 6 cycles during radiotherapy.
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.
Outcomes
Primary Outcome Measures
Overall survival
Overall survival is calculated from randomization to death from any cause.
Failure-free survival
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
Locoregional failure-free survival
the latency to the first local failure
Distant failure-free survival
The latency to the first remote failure
Secondary Outcome Measures
Difference in the complete response rates between the two treatment arms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01854203
Brief Title
Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC
Acronym
NPC
Official Title
Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.
Detailed Description
The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Cisplatin, neoadjuvant chemotherapy, intensity-modulated radiation therapy, concurrent chemoradiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IInductive chemotherapy + concurrent cisplatin and IMRT
Arm Type
Experimental
Arm Description
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30 mg/m2，on day 1) repeated every weeks for 6 cycles during radiotherapy.
Arm Title
Inductive chemotherapy + IMRT
Arm Type
Experimental
Arm Description
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.
Intervention Type
Drug
Intervention Name(s)
Inductive chemotherapy + concurrent cisplatin and IMRT
Other Intervention Name(s)
Gemcitabine and cisplatin
Intervention Description
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2，on day 1) repeated every week for 6 cycles during radiotherapy.
Intervention Type
Drug
Intervention Name(s)
Inductive chemotherapy + IMRT
Other Intervention Name(s)
Gemcitabine and cisplatin
Intervention Description
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival is calculated from randomization to death from any cause.
Time Frame
3-year
Title
Failure-free survival
Description
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
Time Frame
3-year
Title
Locoregional failure-free survival
Description
the latency to the first local failure
Time Frame
3-year
Title
Distant failure-free survival
Description
The latency to the first remote failure
Time Frame
3-year
Secondary Outcome Measure Information:
Title
Difference in the complete response rates between the two treatment arms
Time Frame
12 weeks after the completion of therapy
Other Pre-specified Outcome Measures:
Title
Rates of toxicity
Description
Rates of toxicity will also be compared. Rates will be compared by the chi-square test.The Chemotherapy toxicity include thrombocytopenia, leukocytopenia , anemia, granulocytopenia,damage to hepatic function, damage to renal function,constipation, diarrhea,vomiting and rash. The radiotherapy toxicities include mucositis, radiation dermatitis,dysphagia, xerostomia, skin fibrosis, trismus, hearing loss ane cranial neuropathy.
Time Frame
3-years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).
A Karnofsky performance status of at least 80;
Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0 Stage IVb：Any T、N3.
Adequate marrow: a WBC ≥3.5×109 l-1; a platelet count ≥100×109 l-1; and hemoglobin levels ≥100 g/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: a creatinine clearance rate of at least 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.
Age >65 years or <18 years.
Distant metastasis,
Treatment with palliative intent.
Pregnancy or lactation.
a history of previous radiotherapy in the nasopharyngeal region or previous chemotherapy.
history of renal disease, unstable cardiac disease requiring treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janjun Li, M.D.
Phone
+86+13829745245
Email
lijj@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lizhi Liu, M.D.
Phone
+86+13660528375
Email
liulizh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yong Su, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Janjun Li, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lizhi Liu, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center,Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian-jun Li, MD
Phone
+862087343381
Email
lijj@sysucc.org.cn
Facility Name
State Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian-jun Li, M.D.
First Name & Middle Initial & Last Name & Degree
Li-zhi Liu, M.D.
12. IPD Sharing Statement
Learn more about this trial
Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC
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