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Adjuvant Treatment of Apatinib in Nasopharyngeal Carcinoma

NCT03612219 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-08-02

No results posted yet for this study

Summary

The study is to evaluate the efficacy and safety of apatinib for adjuvant treatment of High-risk metastasis of nasopharyngeal carcinoma after IMRT with concurrent chemotherapy,including progression-free survival (PFS),evaluation of drug safety.,and overall survival (OS),distant metastasisfree survival (DMFS),locoregional relapse-free survival (LRRFS),and quality of life score (QoL).

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

Apatinib mesylate tablet

Adjuvant treatment by apatinib mesylate tablet to local advanced nasopharyngeal carcinoma after IMRT with concurrent chemotherapy.the dose of apatinib mesylate tablet was 250 mg,orally,qd,28 days for an observation period,six cycles.

RADIATION

Intensity-modulated radiation therapy (IMRT)

Intensity-modulated radiation therapy (IMRT):GTVnx 69.69Gy, GTVnd 60-68Gy, PTV1 59.4Gy and PTV2 54Gy in 33 fractions, 5 days/week.

DRUG

Cisplatin

Concurrent chemotherapy: patients received intravenous cisplatin 80mg/m2(D1-3), 3-week chemotherapy for 3 cycles.

Sponsors & Collaborators

  • Wuzhou Red Cross Hospital

    collaborator OTHER

  • Guangxi Minzu Hospital

    collaborator UNKNOWN

  • People's Hospital of Lingshan

    collaborator UNKNOWN

  • Guangxi Naxishan Hospital

    collaborator OTHER

  • People's Hospital of Baise

    collaborator UNKNOWN

  • Laibin People's Hospital

    collaborator OTHER

  • Wei Jiang

    lead OTHER

Principal Investigators

  • Wei Jiang, Ph.D. · Guilin Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2021-07-28
Completion
2021-07-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03612219 on ClinicalTrials.gov