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

Recurrent Nasopharyngeal Carcinoma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03210389
• Other study ID #: B2016-001-01
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 21, 2017
• Last updated: July 5, 2017
• Start date: July 2017
• Est. completion date: December 2021

Study information

• Verified date: July 2017
• Source: Sun Yat-sen University
• Contact: Yun-fei Xia, Professor
• Phone: 86-13602805461
• Email: xiayf[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Nasopharyngeal Neoplasms
• Recurrent Nasopharyngeal Carcinoma

Intervention

Drug:
• Lobaplatin
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.

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	the time from randomization to death or disease progression	2 years after chemotherapy
Secondary	overall survival	the time from randomization to death of any cause	2 years after chemotherapy
Secondary	objective response rate	the ratio that patients who get PR or CR in all the patients	2 years after chemotherapy