Nasopharyngeal CarcinomaPhase 2NCT03932266
Endostar Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregional Nasopharyngeal Carcinoma
A Phase 2 study testing Endostar, Cisplatin and Docetaxel in people with Nasopharyngeal Carcinoma, run by Jiangsu Cancer Institute & Hospital.
Trial summary
Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Endostar, Cisplatin and Docetaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Sep 2023
- Phase
- Phase 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma;
- No chemotherapy, immunotherapy, radiotherapy treatment history.
- No evidence of distant metastasis
- Eastern Cooperative Oncology Group performance score 0-1
- Normal bone marrow function: white blood cell count > 3.5 × 109 / L, hemoglobin > 90 g / L and platelet count > 100 × 109 / L.
- Normal liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) <1.5 times the upper limit of normal (ULN), and alkaline phosphatase (ALP) < 2.5 × ULN
- Normal renal function: creatinine clearance > 60 ml/min.
- The patient must be informed of the basic content of the study and sign an informed consent form.
Who cannot join
- The pathological type is keratinized squamous cell carcinoma or basal squamous cell carcinoma.
- Treatment is palliative.
- A history of malignant tumors, except for well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ.
- Women during pregnancy or lactation (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasized during treatment).
- Previous radiation therapy (except for non-melanoma skin cancer with a previous lesion outside the target area of radiotherapy).
- Primary and cervical metastatic lesions have received chemotherapy or surgery (except for diagnostic treatment).
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- Having other serious illnesses may result in greater risk or affect the compliance of the trial. For example: kidney disease, chronic hepatitis, control of unsatisfactory diabetes (fasting blood glucose > 1.5 × ULN), and mental illness.
- A history of severe heart disease, including: cardiac function ≥ standard II, unstable angina, myocardial infarction, arrhythmia - antiarrhythmic drug therapy (except beta-blockers or digoxin), Uncontrollable hypertension.
- According to the investigator's judgment, there are people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
- Patients with a major bleeding tendency in the primary nasopharyngeal tumors.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma.
Read the detailed description
This study was a multicenter, prospective, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. A total of 73 patients with pathologically confirmed locoregionally advanced nasopharyngeal carcinoma would be enrolled. Patients were randomly divided into two groups, with 48 patients in the combination group and 25 patients in the control group. The combination group was treated with Induction and Concurrent Chemoradiotherapy combined with Endostar. The control group was treated with Induction and Concurrent Chemoradiotherapy. The short term efficacy and side effects of these treatments would be evaluated. The 1-year, 3-year progression-free survival and overall survival would be analyzed. This data of this study might provide an alternative option for the treatment of Locoregionally advanced nasopharyngeal carcinoma with higher efficacy and low toxicity.
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Endostar, Nasopharyngeal Carcinoma, Chemoradiotherapy, Endostatin
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndostarDrug
Also called Recombinant human endostatin injection
Endostar, 15 mg/m2, continous intravenous infusion, 3 cycles during induction chemotherapy, 4 cycles during concurrent chemoradiotherapy.
CisplatinDrug
Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.
DocetaxelDrug
Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.
Intensity Modulated Radiation Therapy (IMRT)Radiation
IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Drug: Endostar Drug: Cisplatin Drug: Docetaxel Radiation Receives: Drug: Endostar; Drug: Cisplatin; Drug: Docetaxel; Radiation: Intensity Modulated Radiation Therapy (IMRT) |
| Control group | Other | Drug: Cisplatin Drug: Docetaxel Radiation Receives: Drug: Cisplatin; Drug: Docetaxel; Radiation: Intensity Modulated Radiation Therapy (IMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
Measured: Approximately 36 months
Secondary outcomes (3)
objective response rate
Complete response (CR)+Partial response (PR) according to RECIST 1.1
Measured: 18months
overall survival (OS)
Overall survival was defined as the time from randomization to death from any cause
Measured: Approximately 36 months
adverse event (AE)
adverse event according to NCI-CTCAE (5.0)
Measured: Approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study startJun 2019 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Xia He, Jiangsu Cancer Institute & Hospital
- Investigators
- Xia He, M.D., Ph.D., Principal investigator, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932266
- Sponsor's protocol ID
- Endo-Naso-001
- Status last verified
- Apr 2019
- First submitted
- 22 Nov 2017
- Last updated
- 30 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
- ClinicalTrials.gov ID
- NCT03932266
- Acronym / sponsor ID
- Endo-Naso-001
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Endostar, Nasopharyngeal Carcinoma, Chemoradiotherapy, Endostatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 30 Apr 2019 (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.
Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma.
Detailed description
This study was a multicenter, prospective, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. A total of 73 patients with pathologically confirmed locoregionally advanced nasopharyngeal carcinoma would be enrolled. Patients were randomly divided into two groups, with 48 patients in the combination group and 25 patients in the control group. The combination group was treated with Induction and Concurrent Chemoradiotherapy combined with Endostar. The control group was treated with Induction and Concurrent Chemoradiotherapy. The short term efficacy and side effects of these treatments would be evaluated. The 1-year, 3-year progression-free survival and overall survival would be analyzed. This data of this study might provide an alternative option for the treatment of Locoregionally advanced nasopharyngeal carcinoma with higher efficacy and low toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Endostar, Drug: Cisplatin, Drug: Docetaxel, Radiation: Intensity Modulated Radiation Therapy (IMRT)Drug: Endostar Drug: Cisplatin Drug: Docetaxel Radiation |
| Control group | Other | Drug: Cisplatin, Drug: Docetaxel, Radiation: Intensity Modulated Radiation Therapy (IMRT)Drug: Cisplatin Drug: Docetaxel Radiation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma;
- No chemotherapy, immunotherapy, radiotherapy treatment history.
- No evidence of distant metastasis
- Eastern Cooperative Oncology Group performance score 0-1
- Normal bone marrow function: white blood cell count > 3.5 × 109 / L, hemoglobin > 90 g / L and platelet count > 100 × 109 / L.
Key exclusion criteria (10 listed)
- The pathological type is keratinized squamous cell carcinoma or basal squamous cell carcinoma.
- Treatment is palliative.
- A history of malignant tumors, except for well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ.
- Women during pregnancy or lactation (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasized during treatment).
- Previous radiation therapy (except for non-melanoma skin cancer with a previous lesion outside the target area of radiotherapy).
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 |
|---|---|---|
| EndostarAlso: Recombinant human endostatin injectionEndostar, 15 mg/m2, continous intravenous infusion, 3 cycles during induction chemotherapy, 4 cycles during concurrent chemoradiotherapy. | Drug | Experimental group |
| CisplatinCisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy. | Drug | Control group, Experimental group |
| DocetaxelDocetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy. | Drug | Control group, Experimental group |
| Intensity Modulated Radiation Therapy (IMRT)IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions | Radiation | Control group, Experimental group |
Primary outcome
progression-free survival (PFS)
Time frame: Approximately 36 months
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
3 secondary outcomes
objective response rate
Time frame: 18months
overall survival (OS)
Time frame: Approximately 36 months
adverse event (AE)
Time frame: Approximately 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
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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.
Xia He, M.D., Ph.D. principal investigator
Jiangsu Cancer Institute & Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endostar, Cisplatin and Docetaxel in people with Nasopharyngeal Carcinoma, run by Jiangsu Cancer Institute & Hospital.
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 8 inclusion and 10 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 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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 Xia He, M.D., Ph.D. (8625-83283597, hexia206@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: Approximately 36 months). 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 30 Apr 2019.