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

Phase 2

• Conditions: Recurrent Nasopharyngeal Carcinoma
• Interventions: Drug: Lobaplatin

• Registration Number: NCT03210389
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-21
• Status Verified: 2017-07
• Study Start: 2017-07
• Study First Submitted QC: 2017-07-05
• Last Update Submitted: 2017-07-05
• Study First Posted: 2017-07-06
• Last Update Posted: 2017-07-06
• Primary Completion: 2019-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lobaplatin+5-FU	Lobaplatin	Patients enrolled in this trial would get 4-6 cycles of lobaplatin + 5-FU chemotherapy.

Primary Outcome Measures

Name	Time	Method
progression-free survival	2 years after chemotherapy	the time from randomization to death or disease progression

Secondary Outcome Measures

Name	Time	Method
overall survival	2 years after chemotherapy	the time from randomization to death of any cause
objective response rate	2 years after chemotherapy	the ratio that patients who get PR or CR in all the patients

Trial Locations

Locations (1)

Department of Radiation Oncology, Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China