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

Sun Yat-sen University

Status and phase

Unknown

Phase 2

Conditions

Recurrent Nasopharyngeal Carcinoma

Treatments

Drug: Lobaplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT03210389

B2016-001-01

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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