Brief Title
Demethylated Drug in the Treatment of Nasopharyngeal Carcinoma
Official Title
Clinical Efficacy Observation of Demethylated Drug Decitabine in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
Brief Summary
The study is to observe the efficacy and toxicity of demethylating drug decitabine and
cisplatin induced chemotherapy for 3 cycles followed by concurrent chemoradiotherapy in the
treatment of regionally advanced nasopharyngeal carcinoma,followed up for 2 years, observing
the 2-year survival rate and variation of degrees of methylation before and after
treatment,providing clinical basis for the clinical study of stage II-III.
Detailed Description
Recent studies and previous studies in the investigator's research group have found that
nasopharyngeal carcinoma is a disease with hypermethylation changes, and epigenetic treatment
has not yet been carried out in nasopharyngeal carcinoma. In this study, Simon's two-stage
design method was used to select 30 patients with nasopharyngeal carcinoma, treated with
demethylating drug decitabine 7mg/m2 d1-5 + cisplatin 80mg/m2 d1 induced chemotherapy for 3
cycles followed by concurrent chemoradiotherapy with cisplatin 80mg/m2. observing the
efficacy and toxicity of decitabine in the treatment of regionally advanced nasopharyngeal
carcinoma, followed up for 2 years, observing the 2-year survival rate,evluating the
relationship between different degrees of methylation and survival before and after
treatment,provide clinical basis for the clinical study of stage II-III.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Progression-free survival
Secondary Outcome
Overall survival
Condition
Nasopharyngeal Carcinoma
Intervention
Demethylated drug decitabine
Study Arms / Comparison Groups
decitabin and cisplatin induced chemotherapy followed by CC
Description: Treated by demethylated drug decitabine injection combined with cisplatin induced chemotherapy followed by concurrent chemoradiotherapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
February 28, 2018
Completion Date
December 1, 2020
Primary Completion Date
December 1, 2020
Eligibility Criteria
Inclusion Criteria:
1. Patients with newly confirmed non-keratinized or undifferentiated carcinoma of the
nasopharynx.
2. Aequate hematological function: WBC ≥ 4 × 10^9 / L before the enrollment, PLT ≥ 100 ×
10^9 / L, HGB ≥ 80.0g / L.
3. Adequete liver function:(serum transminase ≤ 2.5 times higher than upper limit ),
renal function:(creatinine clearance rate ≥ 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 infomed consent.
Exclusion Criteria:
1. Other or mixed pathological type.
2. age >65years.
3. severe heart,liver,and kidney damage.
4. histology of other malignancy .
5. prior chemotherapy or radiation of the primary tumor;Pregnant or lactating women.
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.
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Wei Jiang, PhD, +86-18977330177, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03701451
Organization ID
GLMU-05
Responsible Party
Sponsor-Investigator
Study Sponsor
Wei Jiang
Collaborators
Guilin Hospital of Traditional Chinese Medicine
Study Sponsor
Wei Jiang, PhD, Study Director, Guilin Medical University, China
Verification Date
October 2018