- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02444949
A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma
June 22, 2020 updated by: Xin-Hua Xu, China Three Gorges University, Yichang, China
Among all the head and neck tumors, nasopharyngeal carcinoma (NPC) has a high tendency of recurrence and metastasis.
For the advanced NPC patients, chemoradiotherapy is the main way of treatment.
Currently, chemotherapy with cisplatin (DDP) combines with 5-fluorouracil (5-FU) is the classic front line therapy for NPC.
However, the abnormal richness of angiogenesis of tumor and blood supply in tissue caused by radiation therapy often decrease the effects of radiochemotherapy.
Human recombinant vascular endothelial inhibitor (endostar) can improve the sensitivity to chemoradiation via selectively inhibiting the migration of endothelial cells and the formation of tumor vessels.
Moreover, it would induce vascular remodeling and normalization of the tumor vasculature, which will effectively aid the delivery of oxygen and anticancer drugs.
In sum, antiangiogenesis in combination with chemoradiotherapy will be a promising way of treatment for NPC.
In this study, the first-treated patients with NPC (stage Ⅲ or Ⅳa) confirmed by pathology, and patients with recurrent and metastatic NPC will be randomly assigned to two groups (1:1): a trial group (DDP, 5-FU, endostar and sequential intensity modulated radiation therapy (IMRT)), and a control group (DDP,5-FU and sequential IMRT).
Evaluations will be developed including progression-free survival (PFS), Overall response rate(ORR), overall survival (OS), adverse effects rate and quality of life.
This research will provide more evidences of evidence-based medicine for the safety and tolerability of endostar and the clinical application of endostar in NPC treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age from 18 to 70 ears ;
- Eastern Cooperative Oncology Group performance status of 0-1;
- diagnosed with first-treated NPC (Ⅲ/Ⅳa stage) confirmed by pathology;
- ecurrent and metastatic NPC with indication of chemoradiotherapy;
- one measurable lesion at least (according to the RECIST guidelines, the lesion iameter≥20 mm with MRI);
- life expectancy of ≥ 12 weeks;
- adequate hematologic, renal, cardiac and liver function;
- hemameba≥4.0×109/L;
- neutrophil≥2.0×109/L;
- platelet≥100×109/L;
- hemoglobin≥95g/L;
- Serum bilirubin, ALT and AST ≤1.5 times of maximum criteria;
- sufficiently understand this study situation and signed the informed consent.
Exclusion Criteria:
- allergy or intolerance to study drugs;
- receiving other anti-cancer therapy;
- uncontrolled central nervous system lesions;
- dysfunction of important organs;
- history of cardiovascular disease(including congestive heart-failure, uncontrolled arrhythmia, angina pectoris which require long-term drug treatment, lular heart disease, myocardial infarction and resistant hypertension);
- pregnancy or lactation in women;
- protracted Infective wound;
- history of mental illness which is not easy controlled.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: endostar+DF+IMRT
patient first receive one periodicity chemotherapy(DDP (25mg/m2/d; ivgtt; d1~3)+5-FU (600mg/m2/d; ivgtt; d1~5)+endostar (150mg/5d; civ; d1~5)), then given IMRT (5 times per week, 6 weeks).
After rest 4 weeks, continue to give the chemotherapy (21 days for a periodicity, 3 periodicities).
|
Other Names:
Other Names:
|
Other: DF+IMRT
patient first receive one periodicity chemotherapy(DDP (25mg/m2/d; ivgtt; d1~3)+5-FU (600mg/m2/d; ivgtt; d1~5)), then given IMRT (5 times per week, 6 weeks).
After rest 4 weeks, continue to give the chemotherapy (21 days for a periodicity, 3 periodicities).
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free Survival
Time Frame: Patients will be followed from the day in which patients are enrolled the clinical trial and end up one year later, during the one year the patients will be observed whether they have disease progress or die from any cause.
|
Patients will be followed from the day in which patients are enrolled the clinical trial and end up one year later, during the one year the patients will be observed whether they have disease progress or die from any cause.
|
Overall response rate
Time Frame: After the second periodicity chemotherapy, an expected average of 12 weeks, the rate of patients with complete response and partial response accounted for the total number of assessable cases .
|
After the second periodicity chemotherapy, an expected average of 12 weeks, the rate of patients with complete response and partial response accounted for the total number of assessable cases .
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse effects as assessed by adverse events
Time Frame: It is the time from the start of treatment to 20 weeks
|
It is the time from the start of treatment to 20 weeks
|
Overall survival
Time Frame: Patients will be followed from the day in which patients are enrolled the clinical trial and end up two years later, during the two years the patients will be observed whether they die from any cause.
|
Patients will be followed from the day in which patients are enrolled the clinical trial and end up two years later, during the two years the patients will be observed whether they die from any cause.
|
Quality of Life measured by the ECDG score
Time Frame: Firstly, Patients will be assessed before the start of periodicity treatment, then they will be assessed 20 weeks and 24 weeks after the treatment.
|
Firstly, Patients will be assessed before the start of periodicity treatment, then they will be assessed 20 weeks and 24 weeks after the treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
April 7, 2015
First Submitted That Met QC Criteria
May 14, 2015
First Posted (Estimate)
May 15, 2015
Study Record Updates
Last Update Posted (Actual)
June 24, 2020
Last Update Submitted That Met QC Criteria
June 22, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Cisplatin
- Endostar protein
Other Study ID Numbers
- CTGU001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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