Nasopharyngeal CarcinomaPhase 1/2NCT03701451
Demethylated Drug in the Treatment of Nasopharyngeal Carcinoma
A Phase 1/2 study testing Demethylated drug decitabine in people with Nasopharyngeal Carcinoma, run by Wei Jiang at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Demethylated drug decitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 28 Feb 2018to 1 Dec 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 .
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Guilin Hospital of Traditional Chinese Medicine
Guilin, Guangxi, 541002
Ruihua Xiong, Ph.D.
- Recruiting
Guilin Medical University
Guilin, Guangxi
Rongjun Zhang, Mster, +8618977330177, 41974954@qq.com
Wei Jiang, Ph.D, +8613788561863
About this study
Official title: Clinical Efficacy Observation of Demethylated Drug Decitabine in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
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.
Read the 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.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Demethylated drug decitabine
- Keywords
- Nasopharyngeal Carcinoma, Decitabine, Concurrent chemoradiotherapy, Induced chemotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| decitabin and cisplatin induced chemotherapy followed by CC | Experimental | Treated by demethylated drug decitabine injection combined with cisplatin induced chemotherapy followed by concurrent chemoradiotherapy Receives: Drug: Demethylated drug decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The time from the first day of therapy to death or last follow-up
Measured: 2 years
Secondary outcomes (5)
Overall survival
The time from the first day of therapy to death or last follow-up
Measured: 2 years
Locoregional recurrence-free survival
The time from the first day of therapy to death or last follow-up
Measured: 2 years
Distant metastasis-free survival
The time from the first day of therapy to death or last follow-up
Measured: 2 years
Dgree of methylation Carcinoma
The variations of the dgree of methylation before and after 2 months treatment
Measured: 2 months
Treatment toxicity
The time from the first day of therapy to death or last follow-up
Measured: 2moths to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start28 Feb 2018
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Jiang
- Sponsor type
- University, hospital or other
- Collaborators
- Guilin Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Wei Jiang, Guilin Medical University, China
- Investigators
- Wei Jiang, PhD, Study director, Guilin Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701451
- Sponsor's protocol ID
- GLMU-05
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy Observation of Demethylated Drug Decitabine in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03701451
- Acronym / sponsor ID
- GLMU-05
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Decitabine, Concurrent chemoradiotherapy, Induced chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wei JiangUniversity, hospital or other
- Collaborators
- Guilin Hospital of Traditional Chinese Medicine
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 10 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| decitabin and cisplatin induced chemotherapy followed by CC | Experimental | Drug: Demethylated drug decitabineTreated by demethylated drug decitabine injection combined with cisplatin induced chemotherapy followed by concurrent chemoradiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Demethylated drug decitabineInduced 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. | Drug | decitabin and cisplatin induced chemotherapy followed by CC |
Primary outcome
Progression-free survival
Time frame: 2 years
The time from the first day of therapy to death or last follow-up
5 secondary outcomes
Overall survival
Time frame: 2 years
Locoregional recurrence-free survival
Time frame: 2 years
Distant metastasis-free survival
Time frame: 2 years
Dgree of methylation Carcinoma
Time frame: 2 months
Treatment toxicity
Time frame: 2moths to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Jiang, PhD study director
Guilin Medical University, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Demethylated drug decitabine in people with Nasopharyngeal Carcinoma, run by Wei Jiang at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongjun Zhang, Master (+86-18977330177, 41974954@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.