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Adjuvant Treatment of Apatinib in Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib mesylate tablet
Intensity-modulated radiation therapy (IMRT)
Cisplatin
Sponsored by
Wei Jiang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, Apatinib, Adjuvant treatment, Progression-free survival

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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).
  2. Adequate hematological function: hemoglobin >80 g/L, neutrophil count > 1.5×10^9/L, platelet count 80×10^9/L.
  3. Adequate liver function (serum transminase ≤ 2.5 times higher than upper limit),adequate renal function (creatinine clearance ≥ 60 mL/min).
  4. Karnofsky performance status (KPS) score of at least 70 or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  5. Patients must give signed informed consent.

Exclusion Criteria:

  1. Other or mixed pathological type.
  2. age > 70 years.
  3. Severe heart, liver and kidney damage.
  4. History of other malignancy.
  5. Prior chemotherapy or radiation of the primary tumor.
  6. History of psychiatric disorders.
  7. Positive urine protein.
  8. A healed wound for long time or incomplete fracture.
  9. 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.
  10. Patient who has high blood pressure can not be controlled by a single antihypertensive drug treatment (Systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg.
  11. 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.
  12. 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.
  13. Patient who has serious hemorrhages, any serious bleeding events classification at 3 degree or more (according to CTCAE4.0) within the last 4 weeks.
  14. 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).
  15. 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.
  16. Any factors that affect the oral drug, such as the inability to swallow, diarrhea and intestinal obstruction.
  17. Medical history of immunodeficiency, or other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  18. Any serious harm to the subject's safety or evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Sites / Locations

  • People's Hospital of Baise
  • Guangxi Naxishan Hospital
  • Guilin Medical UniversityRecruiting
  • People's Hospital of Laibin
  • People's Hospital of Lingshan
  • Wuzhou Red Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IMRT with CC+Adjuvant Apatinib

IMRT with CC

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival
The time from the first day of therapy to death or last follow-up
Locoregional relapse-free survival
The time from the first day of treatment to the time of first locoregional relapse
Distant metastasis-free survival
The time from the first day of treatment to the time of first distant metastasis

Full Information

First Posted
July 27, 2018
Last Updated
July 27, 2018
Sponsor
Wei Jiang
Collaborators
Wuzhou Red Cross Hospital, Guangxi Minzu Hospital, People's Hospital of Lingshan, Guangxi Naxishan Hospital, People's Hospital of Baise, Laibin People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03612219
Brief Title
Adjuvant Treatment of Apatinib in Nasopharyngeal Carcinoma
Official Title
A Multicenter, Phase II Clinical Study of Adjuvant Apatinib After IMRT With Concurrent Chemotherapy Versus IMRT With Concurrent Chemotherapy in High-risk Metastasis of Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 28, 2021 (Anticipated)
Study Completion Date
July 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wei Jiang
Collaborators
Wuzhou Red Cross Hospital, Guangxi Minzu Hospital, People's Hospital of Lingshan, Guangxi Naxishan Hospital, People's Hospital of Baise, Laibin People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
PRIMARY OBJECTIVES: Ⅰ.To determine if adjuvant apatinib after IMRT with concurrent chemotherapy is better to only obeservation after IMRT with concurrent chemotherapy for progression-free survival in High-risk metastasis of nasopharyngeal carcinoma. SECONDARY OBJECTIVES: Ⅰ.To explore the adjuvant medication regimen of local advanced nasopharyngeal carcinoma after IMRT with concurrent chemotherapy. Ⅱ.Provide high-level evidence-based medical evidence for the new individualized treatment strategy of nasopharyngeal carcinoma patients. OUTLINE: Patients are randomized to one of the two treatment arms. ARM 1: treat with apatinib(the dose was 250 mg,orally,qd,28 days for an observation period,Six cycles) for adjuvant treatment of local advanced nasopharyngeal carcinoma after IMRT with concurrent chemotherapy. ARM 2:only obeservation after IMRT with concurrent chemotherapy. IMRT: GTVnx 69.69Gy, GTVnd 60-68Gy, PTV1 59.4Gy and PTV2 54Gy in 33 fractions, 5 days/week. Concurrent chemotherapy:Cisplatin 80mg/m2(D1-3), 3-week chemotherapy for 3 cycles. After completion of study therapy, patients are followed up every 3-4 months for 2 years, then every 6 months for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal Carcinoma, Apatinib, Adjuvant treatment, Progression-free survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMRT with CC+Adjuvant Apatinib
Arm Type
Experimental
Arm Description
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).
Arm Title
IMRT with CC
Arm Type
Active Comparator
Arm Description
Only obeservation after Intensity-modulated radiation therapy (IMRT) with concurrent chemotherapy(cisplatin).
Intervention Type
Drug
Intervention Name(s)
Apatinib mesylate tablet
Other Intervention Name(s)
No.
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Intensity-modulated radiation therapy (IMRT)
Other Intervention Name(s)
No.
Intervention Description
Intensity-modulated radiation therapy (IMRT):GTVnx 69.69Gy, GTVnd 60-68Gy, PTV1 59.4Gy and PTV2 54Gy in 33 fractions, 5 days/week.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
No.
Intervention Description
Concurrent chemotherapy: patients received intravenous cisplatin 80mg/m2(D1-3), 3-week chemotherapy for 3 cycles.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
The time from the first day of therapy to locoregional relapse, distant relapse or tumor-related death
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
The time from the first day of therapy to death or last follow-up
Time Frame
3 years
Title
Locoregional relapse-free survival
Description
The time from the first day of treatment to the time of first locoregional relapse
Time Frame
3 years
Title
Distant metastasis-free survival
Description
The time from the first day of treatment to the time of first distant metastasis
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Any factors that affect the oral drug, such as the inability to swallow, diarrhea and intestinal obstruction. Medical history of immunodeficiency, or other acquired, congenital immunodeficiency disease, or history of organ transplantation. Any serious harm to the subject's safety or evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Jiang, Ph.D.
Phone
+86-773-2882906
Email
weijiang@glmc.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Jiang, Ph.D.
Organizational Affiliation
Guilin Medical University, China
Official's Role
Study Director
Facility Information:
Facility Name
People's Hospital of Baise
City
Baise
State/Province
Guangxi
Country
China
Individual Site Status
Enrolling by invitation
Facility Name
Guangxi Naxishan Hospital
City
Guilin
State/Province
Guangxi
Country
China
Individual Site Status
Enrolling by invitation
Facility Name
Guilin Medical University
City
Guilin
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Jiang, Ph.D
Phone
+8613788561863
Email
weijiang@glmc.edu.cn
Facility Name
People's Hospital of Laibin
City
Laibin
State/Province
Guangxi
Country
China
Individual Site Status
Enrolling by invitation
Facility Name
People's Hospital of Lingshan
City
Linshan
State/Province
Guangxi
Country
China
Individual Site Status
Enrolling by invitation
Facility Name
Wuzhou Red Cross Hospital
City
Wuzhou
State/Province
Guangxi
Country
China
Individual Site Status
Enrolling by invitation

12. IPD Sharing Statement

Learn more about this trial

Adjuvant Treatment of Apatinib in Nasopharyngeal Carcinoma

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