Progression Free SurvivalPhase 2NCT03769935
Maintenance Therapy for Small-cell Lung Cancer
A Phase 2 study testing cis Platinum, etoposide, S1 in people with Progression Free Survival, run by Qingdao Central Hospital at 1 site in China.
Trial summary
This study involves patients treated with cisplatin and etoposide (induction therapy), followed by treatment with a drug called S1 (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Progression Free Survival
- What is being tested?
- cis Platinum, etoposide, S1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Jul 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Histopathologically confirmed patients with extensive small cell lung cancer; 2. Karnofsky performance status ≥60; 3. At least one lesion that can measured by CT; 4. Expected to survive for at least 3 months; 5. Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment); 6. White blood cell (WBC) ≥3.0×109/L or Neutrophils (ANC) ≥1.5×109/L; Hemoglobin (HGB) ≥80 g/L；Platelet (PLT) ≥100×109/L; 7. Liver transaminases（AST/ALT）<3.0 times the normal range limit; Total bilirubin（TBIL）<1.5 times the normal range limit; Creatinine（CREAT）<1.5 times the normal range limit; 8. Patients of childbearing age (including female and male patients' partner) must take effective contraception methods; Signed informed consent 9. Must be able to swallow tablets
Who cannot join
- 1. Limited stage disease 2. Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm 3. Other pathological types of tumor except for small cell lung cancer; 4. Patients with a history of severe allergies or allergies; 5. Pregnancy or breastfeeding women; 6. Patients who have previously participated in other clinical trials and have not yet terminated the trial; 7. Patients who have acute infection that difficult to control; 8. Subjects with difficulties in swallowing or known drug malabsorption.
Trial locations and contacts
1 site in 1 country.
China1 site
Qingdao Central Hospital, Qingdao Cancer Hospital
Qingdao, Shandong, 266042
About this study
Official title: Preliminary Study of Maintenance Therapy for Patients With Extensive Stage of Small-cell Lung Cancer
This study involves patients treated with cisplatin and etoposide (induction therapy), followed by treatment with a drug called S1 (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. The primary endpoint is progression free survival and second endpoints are toxicities, overall survival.
Read the detailed description
Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy, and if maintenance therapy with S1 after standard EP regimen induction therapy could prolong progression free survival.
- Conditions
- Progression Free Survival
- Being tested
- cis Platinum, etoposide, S1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cis Platinum, etoposide, S1Drug
cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.
S1 25 mg/m2 oral, everyday until progression disease
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.
S1 25 mg/m2 oral, everyday until progression disease Receives: Drug: cis Platinum, etoposide, S1 |
| active comparator | Active comparator | cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles. Receives: Drug: cis Platinum, etoposide, S1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The progression-free survival in this population of patients
The progression-free survival of the enrolled patients from start the combination treatment with cisplatin, etoposide and S1
Measured: 2.5 years
Secondary outcomes (2)
Percentage of Participants Experiencing an Adverse Event (AE)
Adverse events were recorded and classified from start the treatment by grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0
Measured: 2.5 years
The overall survival in this population of patients.
The overall survival of the enrolled patients from start the combination from start the combination treatment with cisplatin, etoposide and S1
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start1 Jan 2017
- Primary completion1 Jan 2022
- Study completion1 Jul 2022
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qingdao Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769935
- Sponsor's protocol ID
- QingdaoCH2018-12-02
- Status last verified
- Mar 2023
- First submitted
- 6 Dec 2018
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of Maintenance Therapy for Patients With Extensive Stage of Small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03769935
- Acronym / sponsor ID
- QingdaoCH2018-12-02
- Conditions
- Progression Free Survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Qingdao Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 Dec 2018 (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.
This study involves patients treated with cisplatin and etoposide (induction therapy), followed by treatment with a drug called S1 (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. The primary endpoint is progression free survival and second endpoints are toxicities, overall survival.
Detailed description
Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy, and if maintenance therapy with S1 after standard EP regimen induction therapy could prolong progression free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Drug: cis Platinum, etoposide, S1cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles. S1 25 mg/m2 oral, everyday until progression disease |
| active comparator | Active comparator | Drug: cis Platinum, etoposide, S1cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Histopathologically confirmed patients with extensive small cell lung cancer; 2. Karnofsky performance status ≥60; 3. At least one lesion that can measured by CT; 4. Expected to survive for at least 3 months; 5. Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment); 6. White blood cell (WBC) ≥3.0×109/L or Neutrophils (ANC) ≥1.5×109/L; Hemoglobin (HGB) ≥80 g/L；Platelet (PLT) ≥100×109/L; 7. Liver transaminases（AST/ALT）<3.0 times the normal range limit; Total bilirubin（TBIL）<1.5 times the normal range limit; Creatinine（CREAT）<1.5 times the normal range limit; 8. Patients of childbearing age (including female and male patients' partner) must take effective contraception methods; Signed informed consent 9. Must be able to swallow tablets
Key exclusion criteria (1 listed)
- 1. Limited stage disease 2. Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm 3. Other pathological types of tumor except for small cell lung cancer; 4. Patients with a history of severe allergies or allergies; 5. Pregnancy or breastfeeding women; 6. Patients who have previously participated in other clinical trials and have not yet terminated the trial; 7. Patients who have acute infection that difficult to control; 8. Subjects with difficulties in swallowing or known drug malabsorption.
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 |
|---|---|---|
| cis Platinum, etoposide, S1cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles. S1 25 mg/m2 oral, everyday until progression disease | Drug | active comparator, experimental arm |
Primary outcome
The progression-free survival in this population of patients
Time frame: 2.5 years
The progression-free survival of the enrolled patients from start the combination treatment with cisplatin, etoposide and S1
2 secondary outcomes
Percentage of Participants Experiencing an Adverse Event (AE)
Time frame: 2.5 years
The overall survival in this population of patients.
Time frame: 2.5 years
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 29 Mar 2023.
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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.
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 cis Platinum, etoposide, S1 in people with Progression Free Survival, run by Qingdao Central 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: finished, as of the sponsor's last update on 29 Mar 2023. 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?
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?
The progression-free survival in this population of patients (time frame: 2.5 years). 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 29 Mar 2023.