Back to resultsComparison the Effects of Different Neoadjuvant Chemotherapy Regimen on Acute Toxicity, Tumor Response, and Survival in Patients With Advanced Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma
Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Cisplatin
Fluorouracil
Radiation therapy
Leucovorin
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Histological proven NPC.
- 2010 AJCC stage II-IVB.
- Age ≧ 20 years old.
- Performance status of ECOG ≦ 2.
- Adequate liver, renal, and bone marrow functions 5-1 Serum total bilirubin level ≦ 2.5 mg/dl. 5-2 Serum creatinine ≦ 1.6 mg/dl or calculated CCr ≧ 60 cc/min. 5-3 WBC ≧ 3,000/ul 5-4 Platelet count ≧ 100,000/ul
- Signed informed consent.
Exclusion Criteria:
- Presence of distant metastasis.
- Previous radiotherapy or chemotherapy.
- History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast.
- Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
- Female patients who are pregnant or lactating.
Sites / Locations
- Taichung Vaterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Control group
Test group
Arm Description
Neoadjuvant chemotherapy with tri-weekly cisplatin plus fluorouracil × 3 cycles (cisplatin 100 mg/m2, day 1, followed by fluorouracil 1000 mg/m2/d, days 1-4 continuous iv infusion, repeated every 3 weeks) + Intensity-Modulated Radiation Therapy ≧ 70 Gy/35 fractions
Neoadjuvant chemotherapy with weekly cisplatin, fluorouracil and leucovorin × 10 weeks (cisplatin 60 mg/m2 at days 1, 15, 29, 43, 57; alternatively with fluorouracil 2500 mg/m2 + leucovorin 250 mg/m2 at days 8, 22, 36, 50, 64) + Intensity-Modulated Radiation Therapy ≧ 70 Gy/35 fractions
Outcomes
Primary Outcome Measures
Tumor response by RECIST version 1.1
According to RECIST version 1.1
Overall survival
Secondary Outcome Measures
Acute toxicity by CTCAE deifnition
According to CTCAE deifnition
Full Information
NCT ID
NCT02500940
First Posted
June 22, 2015
Last Updated
July 14, 2015
Sponsor
Taichung Veterans General Hospital
Collaborators
Fujian Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02500940
Brief Title
Comparison the Effects of Different Neoadjuvant Chemotherapy Regimen on Acute Toxicity, Tumor Response, and Survival in Patients With Advanced Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital
Collaborators
Fujian Cancer Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to investigate the impact of different neoadjuvant chemotherapy schedules of cisplatin and 5-FU on acute toxicity, tumor response, and long-term survival in patients with advanced nasopharyngeal carcinoma
Detailed Description
Control group: Neoadjuvant chemotherapy with tri-weekly PF × 3 cycles (cisplatin 100 mg/m2, day 1, followed by 5-FU 1000 mg/m2/d, days 1-4 continuous iv infusion, repeated every 3 weeks) + IMRT ≧ 70 Gy/35 fractions
Test group: Neoadjuvant chemotherapy with weekly P-FL × 10 weeks (cisplatin 60 mg/m2 at days 1, 15, 29, 43, 57; alternatively with 5-FU 2500 mg/m2 + Leucovorin 250 mg/m2 at days 8, 22, 36, 50, 64) + IMRT ≧ 70 Gy/35 fractions
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Experimental
Arm Description
Neoadjuvant chemotherapy with tri-weekly cisplatin plus fluorouracil × 3 cycles (cisplatin 100 mg/m2, day 1, followed by fluorouracil 1000 mg/m2/d, days 1-4 continuous iv infusion, repeated every 3 weeks) + Intensity-Modulated Radiation Therapy ≧ 70 Gy/35 fractions
Arm Title
Test group
Arm Type
Active Comparator
Arm Description
Neoadjuvant chemotherapy with weekly cisplatin, fluorouracil and leucovorin × 10 weeks (cisplatin 60 mg/m2 at days 1, 15, 29, 43, 57; alternatively with fluorouracil 2500 mg/m2 + leucovorin 250 mg/m2 at days 8, 22, 36, 50, 64) + Intensity-Modulated Radiation Therapy ≧ 70 Gy/35 fractions
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
CDDP
Intervention Description
Neoadjuvant chemotherapy regimen with cisplatin
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
Neoadjuvant chemotherapy regimen with Fluorouracil
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Other Intervention Name(s)
IMRT
Intervention Description
Intensity-Modulated Radiation Therapy
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
Calcium folinate
Intervention Description
Neoadjuvant chemotherapy regimen with Leucovorin
Primary Outcome Measure Information:
Title
Tumor response by RECIST version 1.1
Description
According to RECIST version 1.1
Time Frame
5 years
Title
Overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Acute toxicity by CTCAE deifnition
Description
According to CTCAE deifnition
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological proven NPC.
2010 AJCC stage II-IVB.
Age ≧ 20 years old.
Performance status of ECOG ≦ 2.
Adequate liver, renal, and bone marrow functions 5-1 Serum total bilirubin level ≦ 2.5 mg/dl. 5-2 Serum creatinine ≦ 1.6 mg/dl or calculated CCr ≧ 60 cc/min. 5-3 WBC ≧ 3,000/ul 5-4 Platelet count ≧ 100,000/ul
Signed informed consent.
Exclusion Criteria:
Presence of distant metastasis.
Previous radiotherapy or chemotherapy.
History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast.
Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
Female patients who are pregnant or lactating.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Jin-Ching, Ph.D
Phone
+886-4-23592525
Ext
5613
Email
jclin@vghtc.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Jin-Ching, Ph.D
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Taichung Vaterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Ching Lin, Professor
Phone
+886 4 23592525
Ext
5613
Email
jclin@vghtc.gov.tw
12. IPD Sharing Statement
Learn more about this trial
Comparison the Effects of Different Neoadjuvant Chemotherapy Regimen on Acute Toxicity, Tumor Response, and Survival in Patients With Advanced Nasopharyngeal Carcinoma
We'll reach out to this number within 24 hrs