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Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03427359
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong-Shenzhen Hospital

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: cisplatin, capecitabine Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Induction Chemotherapy With Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
Actual Study Start Date : January 22, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: cisplatin, capecitabine
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 Name: chemoradiotherapy




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: The University of Hong Kong-Shenzhen Hospital
ClinicalTrials.gov Identifier: NCT03427359     History of Changes
Other Study ID Numbers: O1-HongKongShenzhen
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The University of Hong Kong-Shenzhen Hospital:
nasopharyngeal carcinoma
induction chemotherapy
cisplatin
capecitabine
chemoradiotherapy

Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Capecitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action