Nasopharyngeal Carcinoma
Conditions
Keywords
nasopharyngeal carcinoma, induction chemotherapy, cisplatin, capecitabine, chemoradiotherapy
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).
Interventions
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.
Sponsors
The University of Hong Kong-Shenzhen Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS (progression free survival) | 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. | progression free survival |
Outcome results
None listed