Back to resultsA Clinical Trial of Chemotherapy With Lobaplatin and 5-FU in Recurrent Local or Distant Advanced NPC.
Primary Purpose
Recurrent Nasopharyngeal Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Lobaplatin
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Nasopharyngeal Carcinoma focused on measuring Recurrent Nasopharyngeal Carcinoma, lobaptin
Eligibility Criteria
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
Sites / Locations
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lobaplatin+5-FU
Arm Description
Patients enrolled in this trial would get 4-6 cycles of lobaplatin + 5-FU chemotherapy.
Outcomes
Primary Outcome Measures
progression-free survival
the time from randomization to death or disease progression
Secondary Outcome Measures
overall survival
the time from randomization to death of any cause
objective response rate
the ratio that patients who get PR or CR in all the patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03210389
Brief Title
A Clinical Trial of Chemotherapy With Lobaplatin and 5-FU in Recurrent Local or Distant Advanced NPC.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2017 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Nasopharyngeal Carcinoma
Keywords
Recurrent Nasopharyngeal Carcinoma, lobaptin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lobaplatin+5-FU
Arm Type
Experimental
Arm Description
Patients enrolled in this trial would get 4-6 cycles of lobaplatin + 5-FU chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Lobaplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
progression-free survival
Description
the time from randomization to death or disease progression
Time Frame
2 years after chemotherapy
Secondary Outcome Measure Information:
Title
overall survival
Description
the time from randomization to death of any cause
Time Frame
2 years after chemotherapy
Title
objective response rate
Description
the ratio that patients who get PR or CR in all the patients
Time Frame
2 years after chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun-fei Xia, Professor
Phone
86-13602805461
Email
xiayf@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohui Wang, MD
Phone
86-18826260661
Email
wangxh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-fei Xia, Professor
Organizational Affiliation
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of Chemotherapy With Lobaplatin and 5-FU in Recurrent Local or Distant Advanced NPC.
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