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
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
PFS (progression free survival)
Condition
Nasopharyngeal Carcinoma
Intervention
cisplatin, capecitabine
Study Arms / Comparison Groups
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
65
Start Date
January 22, 2015
Completion Date
December 31, 2017
Primary Completion Date
December 31, 2017
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.
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Administrative Informations
NCT ID
NCT03427359
Organization ID
O1-HongKongShenzhen
Responsible Party
Sponsor
Study Sponsor
The University of Hong Kong-Shenzhen Hospital
Study Sponsor
, ,
Verification Date
January 2018