A Clinical Trial of Chemotherapy With Lobaplatin and 5-FU in Recurrent Local or Distant Advanced NPC.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of chemotherapy with Lobaplatin and 5-FU, in Recurrent Local or Distant Advanced Nasopharyngeal Carcinoma.

Official Title
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A Prospective, Single-arm, and Open Clinical Trial of Chemotherapy With Lobaplatin and 5-FU on Efficacy and Safety in Recurrent Local or Distant Advanced NPC.

Conditions
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Recurrent Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Lobaplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NPC diagnosed by pathology, with measurable lesions and imaging results, such as MRI and CT. Patients with no other lesions but bone metastasis are excluded. Recurrent locally or distant advanced NPC (rT3-4N0-3M0-1) ECOG 0 or 1 Expected survival ≥ 1 year Without dysfunction of heart, lung, liver, kidney and hematopoiesis Patients are voluntary and signed informed consent No other anti-tumor treatment (including steroid) Exclusion Criteria: Allergy history to platinum Use of 5-FU in last 6 months Had major surgery in last 4 weeks, or the wound has not completely healed Toxicity from previous treatment is still ≥CTC AE grade 3 History of other carcinoma in the past 5 years, except for treated carcinoma in situ of cervix, as well as basal cell carcinoma or squamous cell carcinoma of the skin Dysfunction of heart Bleeding ≥CTC AE grade 3 Use of anticoagulant or vitamin K antagonists, except for small dose of aspirin and warfarin for prevention Patients participated in clinical trials of other drugs within last 4 weeks Mental illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lobaplatin+5-FU<br>Patients enrolled in this trial would get 4-6 cycles of lobaplatin + 5-FU chemotherapy. | Drug: Lobaplatin<br>* Patients enrolled will receive lobaplatin 30mg/m2 d1+ 5-FU 0.5g/m2/d d2-5 in every 21days. 4-6 cycles of chemotherapy are recommended.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | the time from randomization to death or disease progression | 2 years after chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | the time from randomization to death of any cause | 2 years after chemotherapy | 
| objective response rate | the ratio that patients who get PR or CR in all the patients | 2 years after chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Nasopharyngeal Carcinoma, lobaptin