Clinical trial NCT03427359: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: nasopharyngeal carcinoma
induction chemotherapy
cisplatin
capecitabine
chemoradiotherapy
Lead sponsor: The University of Hong Kong-Shenzhen Hospital
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: PFS (progression free survival)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: