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Demethylated Drug in the Treatment of Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03701451
Recruitment Status : Recruiting
First Posted : October 10, 2018
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
Guilin Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Wei Jiang, Guilin Medical University, China

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Demethylated drug decitabine Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Efficacy Observation of Demethylated Drug Decitabine in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: decitabin and cisplatin induced chemotherapy followed by CC
Treated by demethylated drug decitabine injection combined with cisplatin induced chemotherapy followed by concurrent chemoradiotherapy
Drug: Demethylated drug decitabine
Induced treatment by demethylating drug decitabine 7mg/m2 d1-5 and cisplatin 80mg/m2 d1 for 3 cycles to regionally advanced nasopharyngeal carcinoma followed by concurrent chemoradiotherapy with cisplatin 80mg/m2 d1 for 3 cycles.




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 years ]
    The time from the first day of therapy to death or last follow-up


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
    The time from the first day of therapy to death or last follow-up

  2. Locoregional recurrence-free survival [ Time Frame: 2 years ]
    The time from the first day of therapy to death or last follow-up

  3. Distant metastasis-free survival [ Time Frame: 2 years ]
    The time from the first day of therapy to death or last follow-up

  4. Dgree of methylation Carcinoma [ Time Frame: 2 months ]
    The variations of the dgree of methylation before and after 2 months treatment

  5. Treatment toxicity [ Time Frame: 2moths to 2 years ]
    The time from the first day of therapy to death or last follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701451


Contacts
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Contact: Rongjun Zhang, Master +86-18977330177 41974954@qq.com

Locations
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China, Guangxi
Guilin Hospital of Traditional Chinese Medicine Recruiting
Guilin, Guangxi, China, 541002
Contact: Ruihua Xiong, Ph.D.         
Guilin Medical University Recruiting
Guilin, Guangxi, China
Contact: Rongjun Zhang, Mster    +8618977330177    41974954@qq.com   
Contact: Wei Jiang, Ph.D    +8613788561863      
Sponsors and Collaborators
Wei Jiang
Guilin Hospital of Traditional Chinese Medicine
Investigators
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Study Director: Wei Jiang, PhD Guilin Medical University, China

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Responsible Party: Wei Jiang, Wei Jiang, MD, PhD, Guilin Medical University, China
ClinicalTrials.gov Identifier: NCT03701451     History of Changes
Other Study ID Numbers: GLMU-05
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wei Jiang, Guilin Medical University, China:
Nasopharyngeal Carcinoma
Decitabine
Concurrent chemoradiotherapy
Induced chemotherapy

Additional relevant MeSH terms:
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Nasopharyngeal 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
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Decitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors