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

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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03210389

Enrollment

Registered

2017-07-06

Start date

2017-07-31

Completion date

2021-12-31

Last updated

2017-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Nasopharyngeal Carcinoma

Keywords

Recurrent Nasopharyngeal Carcinoma, lobaptin

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.

Interventions

DRUGLobaplatin

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactYun-fei Xia, Professor

xiayf@sysucc.org.cn86-13602805461

Backup ContactXiaohui Wang, MD

wangxh@sysucc.org.cn86-18826260661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026