The Efficacy of Induction Chemotherapy With Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 65
- Primary Endpoint
- PFS (progression free survival)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pathological confirmed nasopharyngeal carcinoma.
- •Staged as III to IVB.
- •18-75 years old.
- •Performance status ≤
- •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 >
- •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.
Arms & Interventions
experimental arm
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: cisplatin, capecitabine (Drug)
Outcomes
Primary Outcomes
PFS (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.
progression free survival
Secondary Outcomes
No secondary outcomes reported