Extensive-stage Small Cell Lung CancerPhase 2NCT03135977
Apatinib and Etoposide as the Maintenance Therapy in Extensive-stage Small Cell Lung Cancer After First-line Chemotherapy
A Phase 2 study testing Apatinib, Etoposide in people with Extensive-stage Small Cell Lung Cancer and Lung Cancer, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE) has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and the 2-year survival is extremely low. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer, Lung Cancer
- What is being tested?
- Apatinib, Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytologic diagnosis of extensive-stagesmall cell lung caner(SCLC) ,after first-line therapy
- Performance status of 0～2 on the ECOG criteria
- Expected survival is above three months
- Adequate hematologic (neutrophil count>=1.5×109/L, hemoglobin>=80g/L, platelets>=80×109/L), hepatic function (aspartate transaminase (AST) \& alanine transaminase(ALT) =<upper normal limit(UNL) x2, bilirubin level =< UNL x 1.5)
- Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.
Who cannot join
- suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).
- Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
- Bleeding tendency or coagulation disorders.
- Uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg).
- Urine protein≥++, or urine protein in 24 hours≥2.0g.
- severe uncured wounds, ulcers or fracture.
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- Pregnant or breast-feeding.
- Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
- The researcher believe that the Patient is not suitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sicchuan cancer hospital
Chengdu, Sichuan, 610000
xiaohong Cai, Doctor, 8618036672884, xionghong_cai@hotmail.com
About this study
Official title: A Clincal Trial of Apatinib Mesylate and Etoposide(VP-16) as the Maintenance Therapy in Extensive-stage Small Cell Lung Cancer After First-line Chemotherapy
Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE) has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and the 2-year survival is extremely low. There is no standard maintenance treatment recommendation for ED-SCLC patients after the first-line therapy.Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine,so this clinical trial is designed to investigate the efficacy and safety of apatinib combine with etoposide as maintenance therapy in ED-SCLC patients after first-line chemotherapy in our center.
- Being tested
- Apatinib, Etoposide
- Medical subject headings
- Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib, EtoposideDrug
Also called VP-16
Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) .
| Study group | Role | What they receive |
|---|---|---|
| Apatinib, Etoposide | Experimental | Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) . Receives: Drug: Apatinib, Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The first day of treatment to the date that disease progression is reported
Measured: 6 months
Secondary outcomes (4)
Overall survival
the first day of treatment to death or last survival confirm date
Measured: up to 24 months
Duration of Response
Duration of response is defined as time from the date of the first observed hematologic improvement to the date of the first subsequent documented disease progression or relapse
Measured: up to 24 months
Tumor response rate
The ratio between the number of responders and number of patients assessable for tumor response.
Measured: Time Frame: 3 month
Quality of Life (QoL) questionnaire
in cancer patients and survivors with dermatologic conditions. This is a nontherapeutic and nondiagnostic protocol to obtain quality of life assessments from cancer patients and survivors who have dermatologic conditions, whether related to cancer therapies, or directly related to the primary cancer diagnosis. Data will be collected by using one or more dermatology-specific QoL instruments based on the underlying skin condition/s.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start1 Mar 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small Cell Lung CancerStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xionghong cai, Sichuan Cancer Hospital and Research Institute
- Investigators
- Xionghong Cai, Doctor, Principal investigator, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135977
- Sponsor's protocol ID
- Ahead-SL-20170220
- Status last verified
- Dec 2017
- First submitted
- 27 Apr 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clincal Trial of Apatinib Mesylate and Etoposide(VP-16) as the Maintenance Therapy in Extensive-stage Small Cell Lung Cancer After First-line Chemotherapy
- ClinicalTrials.gov ID
- NCT03135977
- Acronym / sponsor ID
- Ahead-SL-20170220
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 May 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.
Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE) has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and the 2-year survival is extremely low. There is no standard maintenance treatment recommendation for ED-SCLC patients after the first-line therapy.Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine,so this clinical trial is designed to investigate the efficacy and safety of apatinib combine with etoposide as maintenance therapy in ED-SCLC patients after first-line chemotherapy in our center.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib, Etoposide | Experimental | Drug: Apatinib, EtoposidePatients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologic or cytologic diagnosis of extensive-stagesmall cell lung caner(SCLC) ,after first-line therapy
- Performance status of 0～2 on the ECOG criteria
- Expected survival is above three months
- Adequate hematologic (neutrophil count>=1.5×109/L, hemoglobin>=80g/L, platelets>=80×109/L), hepatic function (aspartate transaminase (AST) \& alanine transaminase(ALT) =<upper normal limit(UNL) x2, bilirubin level =< UNL x 1.5)
- Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.
Key exclusion criteria (9 listed)
- suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).
- Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
- Bleeding tendency or coagulation disorders.
- Uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg).
- Urine protein≥++, or urine protein in 24 hours≥2.0g.
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 |
|---|---|---|
| Apatinib, EtoposideAlso: VP-16Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) . | Drug | Apatinib, Etoposide |
Primary outcome
Progression-free survival
Time frame: 6 months
The first day of treatment to the date that disease progression is reported
4 secondary outcomes
Overall survival
Time frame: up to 24 months
Duration of Response
Time frame: up to 24 months
Tumor response rate
Time frame: Time Frame: 3 month
Quality of Life (QoL) questionnaire
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
Xionghong Cai, Doctor principal investigator
Sichuan Cancer Hospital and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib, Etoposide in people with Extensive-stage Small Cell Lung Cancer and Lung Cancer, run by Sichuan Cancer Hospital and Research Institute 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 5 inclusion and 9 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 7 Dec 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 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 Xionghong Cai, Doctor (8618036672884, xionghong_cai@hotmail.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: 6 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 7 Dec 2017.