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

July 5, 2017 updated by: Yun-fei Xia, Sun Yat-sen University

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Department of Radiation Oncology, Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lobaplatin+5-FU
Patients enrolled in this trial would get 4-6 cycles of lobaplatin + 5-FU chemotherapy.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Yun-fei Xia, Professor, Department of Radiation Oncology, Sun Yat-sen University Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

June 21, 2017

First Submitted That Met QC Criteria

July 5, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2016-001-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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