Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma

The University of Hong Kong-Shenzhen Hospital

Status and phase: Completed; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: cisplatin, capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT03427359

O1-HongKongShenzhen

Details and patient eligibility

About

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.

Full 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).

Enrollment: 65 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

experimental arm

Experimental group

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.

Treatment:

Drug: cisplatin, capecitabine