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

NCT03210389 | Unknown Phase 2 DMC

• 1 other identifier: B2016-001-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Nasopharyngeal Carcinoma

Keywords

Recurrent Nasopharyngeal Carcinoma; lobaptin

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  the time from randomization to death or disease progression

  2 years after chemotherapy

Secondary Outcomes (2)

• overall survival

  2 years after chemotherapy

• objective response rate

  2 years after chemotherapy

Study Arms (1)

lobaplatin+5-FU

EXPERIMENTAL

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

Drug: Lobaplatin

Interventions

Lobaplatin 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.

lobaplatin+5-FU

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

lobaplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Yun-fei Xia, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-fei Xia, Professor

CONTACT

86-13602805461; xiayf@sysucc.org.cn

Xiaohui Wang, MD

CONTACT

86-18826260661; wangxh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Radiation Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: July 6, 2017
• Study Start: July 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: July 6, 2017

Record last verified: 2017-07

Locations

CN (1)