Progression Free SurvivalPhase 3NCT03100955
A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer
A Phase 3 study testing cisplatin, etoposide and cisplatin, etoposide, apatinib in people with Progression Free Survival, run by Qingdao University at 1 site in China.
Trial summary
To establish the progression free survival in patients with extensive stage small cell lung cancer treated with cisplatin and etoposide plus or not apatinib Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progression Free Survival
- What is being tested?
- cisplatin, etoposide and cisplatin, etoposide, apatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 1 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically verified SCLC, extensive stages
- WHO performance status 0, 1, 2
- Age 18 years or older
- Treatment naive
- Anticipated survival more than 3 months
- HB >90g/L, ANC>1.5 x 109/L, Platelets >80 x109 /L
- No prognancy
- Signed informed consent
Who cannot join
- Limited stage disease
- Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm
- Uncontrolled hypertension
- Uncontrolled heart failure
- Coagulation problem
- Surgery, trauma, uncontrolled ulcer in 4 weeks.
- Required by physician
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266001
Zhuang Yu, MD, (86)18661805688, yuzhuang2002@163.com
Zhuang Yu, MD, Ph.D
About this study
To establish the progression free survival in patients with extensive stage small cell lung cancer treated with cisplatin and etoposide plus or not apatinib
Read the detailed description
Assess progression free survival, overall survival and toxicity of standard EP regimen combined or not with VEGF tyrosine kinase inhibitor-apatinib. Response measured by RECIST response criteria. Toxicity via physical exam, adverse event review, assessing signs and symptoms, quality of life assessment and blood testing.
- Conditions
- Progression Free Survival
- Being tested
- cisplatin, etoposide, cisplatin, etoposide, apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin, etoposideDrug
The recommended regimen is cisplatin plus etoposide. cisplatin 75 mg/m2 iv on day 1, etoposide 120 mg/m2 iv on day 1-3, 3 weeks a cycle, total for 6 cycles is allowed.
cisplatin, etoposide, apatinibDrug
Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatin and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI apatinib oral daily after chemotherapy treatment. Apatinib 500mg oral, once a day, until disease progression or death or un-tolerated toxicites.
| Study group | Role | What they receive |
|---|---|---|
| EP chemotherapy | Active comparator | Standard treatment or active comparator group contains a platinum drug and a topoisomerase inhibitor. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatinum and etoposide. Receives: Drug: cisplatin, etoposide |
| EP chemotherapy plus apatinib | Experimental | Apatinib treatment or experimental group contains standard chemotherapy and apatinib, a VEGF tyrosine kinase inhibitor. It contains a platinum drug, a topoisomerase inhibitor and a VEGF-TKI. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatinum and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI=apatinib, 500 mg, oral daily after chemotherapy, until disease progression or death or un-tolerated toxicites. Used drugs=cisplatinum and etoposide and apatinib. Receives: Drug: cisplatin, etoposide, apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
from the date of randomization to disease progression
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Mar 2017
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progression Free SurvivalStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, medley nie, Qingdao University
- Investigators
- Zhuang Yu, MD, Ph. D, Study chair, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100955
- Sponsor's protocol ID
- QU20170327
- Status last verified
- Mar 2017
- First submitted
- 26 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03100955
- Acronym / sponsor ID
- QU20170327
- Conditions
- Progression Free Survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 4 Apr 2017 (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.
To establish the progression free survival in patients with extensive stage small cell lung cancer treated with cisplatin and etoposide plus or not apatinib
Detailed description
Assess progression free survival, overall survival and toxicity of standard EP regimen combined or not with VEGF tyrosine kinase inhibitor-apatinib. Response measured by RECIST response criteria. Toxicity via physical exam, adverse event review, assessing signs and symptoms, quality of life assessment and blood testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EP chemotherapy | Active comparator | Drug: cisplatin, etoposideStandard treatment or active comparator group contains a platinum drug and a topoisomerase inhibitor. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatinum and etoposide. |
| EP chemotherapy plus apatinib | Experimental | Drug: cisplatin, etoposide, apatinibApatinib treatment or experimental group contains standard chemotherapy and apatinib, a VEGF tyrosine kinase inhibitor. It contains a platinum drug, a topoisomerase inhibitor and a VEGF-TKI. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatinum and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI=apatinib, 500 mg, oral daily after chemotherapy, until disease progression or death or un-tolerated toxicites. Used drugs=cisplatinum and etoposide and apatinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically verified SCLC, extensive stages
- WHO performance status 0, 1, 2
- Age 18 years or older
- Treatment naive
- Anticipated survival more than 3 months
Key exclusion criteria (7 listed)
- Limited stage disease
- Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm
- Uncontrolled hypertension
- Uncontrolled heart failure
- Coagulation problem
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 |
|---|---|---|
| cisplatin, etoposideThe recommended regimen is cisplatin plus etoposide. cisplatin 75 mg/m2 iv on day 1, etoposide 120 mg/m2 iv on day 1-3, 3 weeks a cycle, total for 6 cycles is allowed. | Drug | EP chemotherapy |
| cisplatin, etoposide, apatinibStandard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatin and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI apatinib oral daily after chemotherapy treatment. Apatinib 500mg oral, once a day, until disease progression or death or un-tolerated toxicites. | Drug | EP chemotherapy plus apatinib |
Primary outcome
progression free survival
Time frame: 24 months
from the date of randomization to disease progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Zhuang Yu, MD, Ph. D study chair
The Affiliated Hospital of Qingdao University
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 cisplatin, etoposide and cisplatin, etoposide, apatinib in people with Progression Free Survival, run by Qingdao University 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 8 inclusion and 7 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 4 Apr 2017. 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 keke nie, MD ((86)18561857907, niekekeqd@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 (time frame: 24 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 4 Apr 2017.