Effects of ChemotherapyPhase 3NCT01915134
Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma
A Phase 3 study testing Recombinant Human Endostatin plus gemcitabine and cisplatin and Gemcitabine and cisplatin in people with Effects of Chemotherapy and Stage IVC Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Effects of Chemotherapy, Stage IVC Nasopharyngeal Carcinoma
- What is being tested?
- Recombinant Human Endostatin plus gemcitabine and cisplatin and Gemcitabine and cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Dec 2016
- Phase
- Phase 3
- 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
- metastatic nasopharyngeal carcinoma 6 months after first treatment,never receive any anticancer treatment except local radiotherapy to the bone metastasis，at least one measurable metastatic lesions，ECOG PS 0-1，Electrocardiogram (ecg) no special abnormal，comply with the test requirements, cooperate with regular follow-up.
Who cannot join
- To give local treatment,clinical severe infection(>grade 2),with the central nervous system metastases,ECOG PS≥2,patients with pregnancy or breastfeeding,has a history of peripheral nerve disease,concomitant with other serious diseases,ever or concomitant with other serious diseases except for Cervical carcinoma in situ,cure of basal cell carcinoma,bladder surface tumor,any cancer 3 years after curation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Bin Li, 86-571-88122091, libindoctor@163.com
Xinglai Feng, 86-571-88122092, fengxinglai@hotmail.com
About this study
Official title: A Prospective,Randomized,Controlled,Multicenter,Phase III Study of Stage Ⅲ Study of Gemcitabine Plus Cisplatin With or Without Endostatin to the Metastatic Nasopharyngeal Carcinoma
The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).
Read the detailed description
To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (NPC).
- Being tested
- Recombinant Human Endostatin plus gemcitabine and cisplatin, Gemcitabine and cisplatin
- Keywords
- nasopharyngeal carcinoma, Recombinant Human Endostatin, chemotherapy, gemcitabine and cisplatin
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Endostatin plus gemcitabine and cisplatinDrug
Also called Experimental: EGP group
target therapy plus chemotherapy:4-6 cycles of Recombinant Human Endostatin plus gemcitabine and cisplatin:Endostatin：7.5mg/m2/d,d1-14,concomitant with chemotherapy for 4-6 cycles.Gemcitabine and cisplatin:4-6 cycles of GP chemotherapy with gemcitabine 1000mg/m2,d1,8,cisplatin80mg/m2,d1.Chemotherapy will be given once every three weeks.
Gemcitabine and cisplatinDrug
Also called No Intervention: GP group
only chemotherapy：Gemcitabine and cisplatin:4-6 cycles of GP chemotherapy with gemcitabine 1000mg/m2,d1,8,cisplatin80mg/m2,d1.Chemotherapy will be given once every three weeks.
| Study group | Role | What they receive |
|---|---|---|
| EGP group | Experimental | the group of participants who undergoing Recombinant Human Endostatin plus Gemcitabine and cisplatin chemotherapy Receives: Drug: Recombinant Human Endostatin plus gemcitabine and cisplatin |
| GP group | Active comparator | the group of participants who undergoing only Gemcitabine and cisplatin chemotherapy Receives: Drug: Gemcitabine and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
progress free survival(PFS)
PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups.
Measured: 2years after the inception assignment
Secondary outcomes (2)
overall survival(OS)
the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to calculate the 2-year ,3-year,5-year overall survival rate,and find is there any significant difference between these two groups.
Measured: 1 year ,2 years and 3 years after the inception of the assignment
Adverse events
observe and record the toxicity profile(including but not limit to mucositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edition) during the neoadjuvant chemotherapy ,chemoradiation and follow-up.
Measured: participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of ChemotherapyStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Sir Run Run Shaw Hospital
- Responsible party
- Sponsor
- Investigators
- Xiaozhong Chen, Principal investigator, Zhejiang Cancer HospitalXiaozhong Chen, Principal investigator, Zhejiang Cancer Hospital Hangzhou, Zhejiang, China 310022
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915134
- Sponsor's protocol ID
- ZhejaingCH-npc-03
- Status last verified
- Jul 2013
- First submitted
- 21 Jul 2013
- Last updated
- 1 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Randomized,Controlled,Multicenter,Phase III Study of Stage Ⅲ Study of Gemcitabine Plus Cisplatin With or Without Endostatin to the Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT01915134
- Acronym / sponsor ID
- ZhejaingCH-npc-03
- Keywords
- nasopharyngeal carcinoma, Recombinant Human Endostatin, chemotherapy, gemcitabine and cisplatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Sir Run Run Shaw Hospital
- Study start
- Aug 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Aug 2013 (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.
The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).
Detailed description
To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (NPC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGP group | Experimental | Drug: Recombinant Human Endostatin plus gemcitabine and cisplatinthe group of participants who undergoing Recombinant Human Endostatin plus Gemcitabine and cisplatin chemotherapy |
| GP group | Active comparator | Drug: Gemcitabine and cisplatinthe group of participants who undergoing only Gemcitabine and cisplatin chemotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- metastatic nasopharyngeal carcinoma 6 months after first treatment,never receive any anticancer treatment except local radiotherapy to the bone metastasis，at least one measurable metastatic lesions，ECOG PS 0-1，Electrocardiogram (ecg) no special abnormal，comply with the test requirements, cooperate with regular follow-up.
Key exclusion criteria (1 listed)
- To give local treatment,clinical severe infection(>grade 2),with the central nervous system metastases,ECOG PS≥2,patients with pregnancy or breastfeeding,has a history of peripheral nerve disease,concomitant with other serious diseases,ever or concomitant with other serious diseases except for Cervical carcinoma in situ,cure of basal cell carcinoma,bladder surface tumor,any cancer 3 years after curation.
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 |
|---|---|---|
| Recombinant Human Endostatin plus gemcitabine and cisplatinAlso: Experimental: EGP grouptarget therapy plus chemotherapy:4-6 cycles of Recombinant Human Endostatin plus gemcitabine and cisplatin:Endostatin：7.5mg/m2/d,d1-14,concomitant with chemotherapy for 4-6 cycles.Gemcitabine and cisplatin:4-6 cycles of GP chemotherapy with gemcitabine 1000mg/m2,d1,8,cisplatin80mg/m2,d1.Chemotherapy will be given once every three weeks. | Drug | EGP group |
| Gemcitabine and cisplatinAlso: No Intervention: GP grouponly chemotherapy：Gemcitabine and cisplatin:4-6 cycles of GP chemotherapy with gemcitabine 1000mg/m2,d1,8,cisplatin80mg/m2,d1.Chemotherapy will be given once every three weeks. | Drug | GP group |
Primary outcome
progress free survival(PFS)
Time frame: 2years after the inception assignment
PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups.
2 secondary outcomes
overall survival(OS)
Time frame: 1 year ,2 years and 3 years after the inception of the assignment
Adverse events
Time frame: participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2015.
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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.
Xiaozhong Chen principal investigator
Zhejiang Cancer Hospital
Xiaozhong Chen principal investigator
Zhejiang Cancer Hospital Hangzhou, Zhejiang, China 310022
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Human Endostatin plus gemcitabine and cisplatin and Gemcitabine and cisplatin in people with Effects of Chemotherapy and Stage IVC Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site 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 1 inclusion and 1 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 1 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xiaozhong Chen (86-571-88122098, cxzfyun@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progress free survival(PFS) (time frame: 2years after the inception assignment). 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 1 Jan 2015.