NCT03701451

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2018

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

October 8, 2018

Last Update Submit

October 9, 2018

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal CarcinomaDecitabineConcurrent chemoradiotherapyInduced chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    The time from the first day of therapy to death or last follow-up

    2 years

Secondary Outcomes (5)

  • Overall survival

    2 years

  • Locoregional recurrence-free survival

    2 years

  • Distant metastasis-free survival

    2 years

  • Dgree of methylation Carcinoma

    2 months

  • Treatment toxicity

    2moths to 2 years

Study Arms (1)

decitabin and cisplatin induced chemotherapy followed by CC

EXPERIMENTAL

Treated by demethylated drug decitabine injection combined with cisplatin induced chemotherapy followed by concurrent chemoradiotherapy

Drug: Demethylated drug decitabine

Interventions

Demethylated drug decitabineDRUG

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.

decitabin and cisplatin induced chemotherapy followed by CC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with newly confirmed non-keratinized or undifferentiated carcinoma of the nasopharynx.
  • Aequate hematological function: WBC ≥ 4 × 10\^9 / L before the enrollment, PLT ≥ 100 × 10\^9 / L, HGB ≥ 80.0g / L.
  • Adequete liver function:(serum transminase ≤ 2.5 times higher than upper limit ), renal function:(creatinine clearance rate ≥ 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 infomed consent.

You may not qualify if:

  • Other or mixed pathological type.
  • age \>65years.
  • severe heart,liver,and kidney damage.
  • histology of other malignancy .
  • prior chemotherapy or radiation of the primary tumor;Pregnant or lactating women.
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guilin Hospital of Traditional Chinese Medicine

Guilin, Guangxi, 541002, China

RECRUITING

Guilin Medical University

Guilin, Guangxi, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Wei Jiang, PhD

    Guilin Medical University, China

    STUDY DIRECTOR

Central Study Contacts

Rongjun Zhang, Master

CONTACT

+86-1897733017741974954@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Wei Jiang, MD, PhD

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 10, 2018

Study Start

February 28, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

October 10, 2018

Record last verified: 2018-10

Locations

CN(2)