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

NCT ID: NCT03210389

Last Updated: 2017-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2021-12-31

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.

Detailed Description

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Conditions

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Recurrent Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lobaplatin+5-FU

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

Group Type EXPERIMENTAL

Lobaplatin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yun-fei Xia

Director of Department of Radiation Oncology, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yun-fei Xia, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Locations

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Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Yun-fei Xia, Professor

Role: CONTACT

86-13602805461

Xiaohui Wang, MD

Role: CONTACT

86-18826260661

Other Identifiers

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B2016-001-01

Identifier Type: -

Identifier Source: org_study_id

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