Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-01 @ 7:22 PM
Study NCT ID:
NCT03427359
Status:
COMPLETED
Last Update Posted:
2018-02-09
First Post:
2018-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma
Sponsor:
The University of Hong Kong-Shenzhen Hospital
Organization:
Study Overview
Official Title:
The Efficacy of Induction Chemotherapy With Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: