Nasopharyngeal NeoplasmsPhase 2NCT02444949
A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma
A Phase 2 study testing endostar, intensity modulated radiation and cisplatin in people with Nasopharyngeal Neoplasms, run by China Three Gorges University, Yichang, China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Neoplasms
- What is being tested?
- endostar, intensity modulated radiation and cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2019
- 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
- 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;
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- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Nasopharyngeal Neoplasms
- Being tested
- endostar, intensity modulated radiation, cisplatin
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endostarDrug
Also called Human recombinant vascular endothelial inhibitor
intensity modulated radiationRadiation
cisplatinDrug
Also called DDP
| Study group | Role | What they receive |
|---|---|---|
| endostar+DF+IMRT | Experimental | 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). Receives: Drug: endostar; Radiation: intensity modulated radiation; Drug: cisplatin |
| DF+IMRT | Other | 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). Receives: Radiation: intensity modulated radiation; Drug: cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Measured: 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
Measured: 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 outcomes (3)
Adverse effects as assessed by adverse events
Measured: It is the time from the start of treatment to 20 weeks
Overall survival
Measured: 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
Measured: Firstly, Patients will be assessed before the start of periodicity treatment, then they will be assessed 20 weeks and 24 weeks after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2016
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal NeoplasmsStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Three Gorges University, Yichang, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin-Hua Xu, China Three Gorges University, Yichang, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444949
- Sponsor's protocol ID
- CTGU001
- Status last verified
- Jun 2020
- First submitted
- 7 Apr 2015
- Last updated
- 24 Jun 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT02444949
- Acronym / sponsor ID
- CTGU001
- Conditions
- Nasopharyngeal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- China Three Gorges University, Yichang, ChinaUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 15 May 2015 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endostar+DF+IMRT | Experimental | Drug: endostar, Radiation: intensity modulated radiation, Drug: cisplatinpatient 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). |
| DF+IMRT | Other | Radiation: intensity modulated radiation, Drug: cisplatinpatient 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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);
Key exclusion criteria (8 listed)
- 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);
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: Human recombinant vascular endothelial inhibitor | Drug | endostar+DF+IMRT |
| intensity modulated radiation | Radiation | DF+IMRT, endostar+DF+IMRT |
| cisplatinAlso: DDP | Drug | DF+IMRT, endostar+DF+IMRT |
Primary outcome
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.
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 .
3 secondary outcomes
Adverse effects as assessed by adverse events
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing endostar, intensity modulated radiation and cisplatin in people with Nasopharyngeal Neoplasms, run by China Three Gorges University, Yichang, 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 13 inclusion and 8 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: finished, as of the sponsor's last update on 24 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. 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 24 Jun 2020.