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Completed

NCT Number: NCT03427359

Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cisplatin, capecitabine

Drug

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.

Other names: chemoradiotherapy

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong-Shenzhen Hospital

Other

Registry information

Official study title

The Efficacy of Induction Chemotherapy With Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2018
Registry last updated
Feb 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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