Adjuvant Treatment of Apatinib in Nasopharyngeal Carcinoma

NCT03612219 | Unknown Phase 2

• 1 other identifier: GLMU-04
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Nasopharyngeal Carcinoma; Apatinib; Adjuvant treatment; Progression-free survival

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The time from the first day of therapy to locoregional relapse, distant relapse or tumor-related death

  3 years

Secondary Outcomes (3)

• Overall survival

  3 years

• Locoregional relapse-free survival

  3 years

• Distant metastasis-free survival

  3 years

Study Arms (2)

IMRT with CC+Adjuvant Apatinib

EXPERIMENTAL

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).

Drug: Apatinib mesylate tablet; Radiation: Intensity-modulated radiation therapy (IMRT); Drug: Cisplatin

IMRT with CC

ACTIVE COMPARATOR

Only obeservation after Intensity-modulated radiation therapy (IMRT) with concurrent chemotherapy(cisplatin).

Radiation: Intensity-modulated radiation therapy (IMRT); Drug: Cisplatin

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.

Also known as: No.

IMRT with CC+Adjuvant Apatinib

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.

Also known as: No.

IMRT with CC; IMRT with CC+Adjuvant Apatinib

Cisplatin DRUG

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

Also known as: No.

IMRT with CC; IMRT with CC+Adjuvant Apatinib

Eligibility Criteria

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

You may qualify if:

• Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type) Tumor staged as T4 or N2-3 or lymph node\>3cm and M0(according to the 8th AJCC edition).
• Adequate hematological function: hemoglobin \>80 g/L, neutrophil count \> 1.5×10\^9/L, platelet count 80×10\^9/L.
• Adequate liver function (serum transminase ≤ 2.5 times higher than upper limit),adequate renal function (creatinine clearance ≥ 60 mL/min).
• Karnofsky performance status (KPS) score of at least 70 or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients must give signed informed consent.

You may not qualify if:

• Other or mixed pathological type.
• age \> 70 years.
• Severe heart, liver and kidney damage.
• History of other malignancy.
• Prior chemotherapy or radiation of the primary tumor.
• History of psychiatric disorders.
• Positive urine protein.
• A healed wound for long time or incomplete fracture.
• Before treatment,MRI showed that the tumor might be an important risk factor (for example, wrapping around the internal carotid artery / vein); or researchers judged that the tumor is a high risk of serious blood vessel bleeding during the treatment.
• Patient who has high blood pressure can not be controlled by a single antihypertensive drug treatment (Systolic pressure \> 140 mmHg, diastolic pressure \> 90 mmHg.
• Any unstable angina pectoris;with a history of angina pectoris were newly diagnosed with angina pectoris within 3 months before screening; any myocardial infarction events occurred within 6 months before screening; arrhythmia (including QTcF: male ≥ 450ms, female ≥ 470 ms) need long time use of antiarrhythmic drugs and heart function insufficiency ≥II according to New York Heart Association class.
• Medical history of arteriovenous thrombosis event within the past year, such as cerebral vascular accident (including transient ischemic attack) and deep venous thrombosis (venous catheter thrombosis caused by chemotherapy and investigator judged that the patient had recovered, these patients should be except) and pulmonary embolism.
• Patient who has serious hemorrhages, any serious bleeding events classification at 3 degree or more (according to CTCAE4.0) within the last 4 weeks.
• Patient who has abnormal coagulation and bleeding tendency (signed informed consent before 14 days, and must be satisfied: INR is in the normal range without the use of anticoagulants); Application of anticoagulants or vitamin K antagonists such as Hua Falin, heparin or its analogues, with international normalized ratio (INR) is less than 1.5, allows the use of small dose Hua Falin (1 mg orally, once daily) or small dose aspirin (total dose ≤ 100 mg daily).
• For females:patients should be surgical sterilization or postmenopausal patients, or willing to receive a medical approved contraception during treatment and 6 months after the end of the treatment; serum or urine pregnancy test must be negative, and must be non lactating period within 7 days before study; for males: patients should be treated with surgical sterilization or willing to receive a medical approved contraception during treatment and 6 months after the end of the treatment.

Sponsors & Collaborators

• Wei Jiang: lead
• Wuzhou Red Cross Hospital: collaborator
• Guangxi Minzu Hospital: collaborator
• People's Hospital of Lingshan: collaborator
• Guangxi Naxishan Hospital: collaborator
• People's Hospital of Baise: collaborator
• Laibin People's Hospital: collaborator

Study Sites (6)

People's Hospital of Baise

Baise City, Guangxi, China

ENROLLING BY INVITATION

Guangxi Naxishan Hospital

Guilin, Guangxi, China

ENROLLING BY INVITATION

Guilin Medical University

Guilin, Guangxi, China

RECRUITING

People's Hospital of Laibin

Laibin, Guangxi, China

ENROLLING BY INVITATION

People's Hospital of Lingshan

Linshan, Guangxi, China

ENROLLING BY INVITATION

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

ENROLLING BY INVITATION

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

apatinib; Radiotherapy, Intensity-Modulated; Cisplatin

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

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Wei Jiang, Ph.D.

  Guilin Medical University, China

  STUDY DIRECTOR

Central Study Contacts

Wei Jiang, Ph.D.

CONTACT

+86-773-2882906; weijiang@glmc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Wei Jiang, MD, PhD

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 2, 2018
• Study Start: July 1, 2018
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: August 2, 2018

Record last verified: 2018-07

Locations

CN (6)