Back to resultsInduction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
cisplatin, capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring nasopharyngeal carcinoma, induction chemotherapy, cisplatin, capecitabine, chemoradiotherapy
Eligibility Criteria
Inclusion Criteria:
- Pathological confirmed nasopharyngeal carcinoma.
- Staged as III to IVB.
- 18-75 years old.
- Performance status ≤2.
- No previous chemotherapy or radiotherapy.
- No concurrent malignancies or a history of other malignancies.
- Adequate bone marrow function (absolute neutrophil count ≥1.5×109/L, platelets ≥100×109/L).
- Adequate liver and renal function (serum bilirubin and serum transaminase levels less than twice the upper limit of normal, creatinine clearance ≥ 60ml/min).
- Without serious co-morbidity.
Exclusion Criteria:
- Stage I-II or IVC.
- Allergic to cisplatin or capecitabine
- Age <18 or >75
- Performance Status >2.
- Without adequate bone marrow or liver function or renal function.
- Severe co-morbidity and can not tolerate chemotherapy.
- Other conditions not suitable for the study on the discretion of charging doctor.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental arm
Arm Description
Induction chemotherapy: capecitabine tablet 1000mg/m2 po bid from day1 to 14,cisplatin injection 80mg/m2 iv day1,every 3 weeks for a total of 3 cycles. Then followed by concurrent chemoradiotherapy with cisplatin injection 100mg/m2 iv every 3 weeks for a total of 2 cycles.
Outcomes
Primary Outcome Measures
PFS (progression free survival)
progression free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT03427359
First Posted
January 21, 2018
Last Updated
February 2, 2018
Sponsor
The University of Hong Kong-Shenzhen Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03427359
Brief Title
Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma
Official Title
The Efficacy of Induction Chemotherapy With Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 22, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong-Shenzhen Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To prospectively evaluate the short-term efficacy and toxicity of induction chemotherapy with cisplatin and capecitabine followed by concurrent chemoradiotherapy (CCRT) in the treatment of locally advanced nasopharyngeal carcinoma.
Detailed Description
All patients received 3 cycles of induction chemotherapy:cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy. Intensity-modified radiotherapy (IMRT) were used in all patients with the total dose and dose/fraction (Fr) as follows: PTV (planned target volume)_1:70 grays (Gy) at 2 Gy/ Fr, PTV_2:63 Gy at 1.8 Gy/ Fr, PTV_3:56 Gy at 1.6 Gy/ Fr;5 fractions per week. Tumor response was evaluated after 3 cycles of induction chemotherapy and 16 weeks following completion of CCRT according to the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST1.1). All toxicities were gauged based on the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE 4.03).
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, cisplatin, capecitabine, chemoradiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
All patients received 3 cycles of induction chemotherapy (cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks) followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy.
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental arm
Arm Type
Experimental
Arm Description
Induction chemotherapy: capecitabine tablet 1000mg/m2 po bid from day1 to 14,cisplatin injection 80mg/m2 iv day1,every 3 weeks for a total of 3 cycles. Then followed by concurrent chemoradiotherapy with cisplatin injection 100mg/m2 iv every 3 weeks for a total of 2 cycles.
Intervention Type
Drug
Intervention Name(s)
cisplatin, capecitabine
Other Intervention Name(s)
chemoradiotherapy
Intervention Description
Experimental arm patients received 3 cycles of induction chemotherapy (cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks) followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy.
Primary Outcome Measure Information:
Title
PFS (progression free survival)
Description
progression free survival
Time Frame
From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathological confirmed nasopharyngeal carcinoma.
Staged as III to IVB.
18-75 years old.
Performance status ≤2.
No previous chemotherapy or radiotherapy.
No concurrent malignancies or a history of other malignancies.
Adequate bone marrow function (absolute neutrophil count ≥1.5×109/L, platelets ≥100×109/L).
Adequate liver and renal function (serum bilirubin and serum transaminase levels less than twice the upper limit of normal, creatinine clearance ≥ 60ml/min).
Without serious co-morbidity.
Exclusion Criteria:
Stage I-II or IVC.
Allergic to cisplatin or capecitabine
Age <18 or >75
Performance Status >2.
Without adequate bone marrow or liver function or renal function.
Severe co-morbidity and can not tolerate chemotherapy.
Other conditions not suitable for the study on the discretion of charging doctor.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma
We'll reach out to this number within 24 hrs