Adjuvant Treatment of Apatinib in Nasopharyngeal Carcinoma

Sponsor
Wei Jiang
Study ID
NCT03612219
Phase
PHASE2
Status
Unknown

Conditions

  • Nasopharyngeal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib mesylate tablet — DRUG
    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.
  • Intensity-modulated radiation therapy (IMRT) — RADIATION
    Intensity-modulated radiation therapy (IMRT):GTVnx 69.69Gy, GTVnd 60-68Gy, PTV1 59.4Gy and PTV2 54Gy in 33 fractions, 5 days/week.
  • Cisplatin — DRUG
    Concurrent chemotherapy: patients received intravenous cisplatin 80mg/m2(D1-3), 3-week chemotherapy for 3 cycles.

Study Details

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).

Key Dates

Start date
Jul 1, 2018
Status verified
Jul 2018
Primary completion
Jul 28, 2021
Completion
Jul 28, 2021

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IMRT with CC+Adjuvant Apatinib
    Treat with Apatinib mesylate tablet for adjuvant treatment(the dose was 250 mg,orally,qd,28 days for an observation period,Six cycles)of local advanced nasopharyngeal carcinoma after Intensity-modulated radiation therapy (IMRT) with concurrent chemotherapy(cisplatin).
  • Active Comparator: IMRT with CC
    Only obeservation after Intensity-modulated radiation therapy (IMRT) with concurrent chemotherapy(cisplatin).

Primary Outcome Measure

Progression-free survival [ Time Frame: 3 years ]

Central Contacts

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