Small Cell Lung CancerPhase 4NCT02348450
Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer
A Phase 4 study testing Irinotecan, Etoposide and Cisplatin in people with Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 20 sites in China.
Trial summary
This study is aimed to evaluate the progression-free survival(PFS) and also survival of IP and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer and to explore the reasonable first-line therapy for Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Irinotecan, Etoposide and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 20 sitesChina
- Study dates
- Feb 2015to Dec 2018
- Phase
- Phase 4
- 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
- Cytologically or histologically confirmed extensive stage small-cell lung cancer (remote metastasis and/or contralateral lymph-node involvement; not those with simple ipsilateral pleural effusion);
- No prior radiotherapy, chemotherapy or surgery;
- At least one measurable lesion, CT≥20mm, spiral CT≥10mm(diameter);
- ECOG PS 0-1;
- Age 18-70;
- Life expectancy > three months;
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- In general normal function of heart, liver, kidney and bone marrow;
- WBC C>4.0×10(9)/L, NEUT>1.50×10(9)/L, PLT>100×10(9)/L, Hb>95g/L;
- Liver function: TBIL < 1.5 x UL normal range; ALT and AST < 1.5 x UL normal range;
- Kidney function: normal serum creatinine level;
- Signed an informed consent and will comply with the study protocol and follow-up plans.
Who cannot join
- Failed to meet the entry criteria of pathology and clinical stage;
- Have received prior chemotherapy or target treatment;
- Currently receiving other anticancer therapy;
- No measurable lesions or lesions cannot be assessed;
- Patients with acute or chronic medical or psychiatric condition, or laboratory abnormalities that may impact the judgment of the investigator and the result of the study, determined by investigator they may include:
- Uncontrolled tumor metastasis in central nerve system; Uncontrolled hypertension, unstable angina, MI history, or congestive heart-failure, uncontrolled arrhythmia, ischemic vascular disease within the 12 months prior to study treatment; Myocardial ischemia by ECG or valvular heart disease; Grade 3 or above peripheral neuropathy; Active stage of infection by bacteria, fungi or virus; Pregnant or breast feeding woman; History of uncontrolled mental disease.
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- Not able to discontinue NSAIDs treatment;
- Other active malignant tumors except non-melanoma skin cancer, in-situ cervical carcinoma and cured early prostatic carcinoma;
- Patients with allergies, known or may be allergic to drugs in research;
- Patients with poor compliance to treatment and follow-up;
- Patients with UGT1A1-6 and UGT1A1-28 gene mutation;
- With clinical symptoms of brain metastasis(patient with stable clinical performance and no need to treat can be included in the trial);
- Chest, abdominal or pericardial effusion that needs anti-cancer intervention;
- Accompanied with Grade ≥2 diarrhea;
- Participated in other clinical trials within one month before randomization;
- Investigator's judgment to exclude.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites, 14 recruiting
- Recruiting
HuNan Provincial Tumor Hospital
Changsha, Hunan
jianhua chen
yongzhong luo, 13607443876, 65523714@qq.com
- Not yet recruiting
FuJian Provincial Tumor Hospital
Fuzhou, Fujian
cheng huang, 13905010379, cheng671@sina.com
- Active, not recruiting
Guangdong General Hospital
Guangzhou, Guangdong
- Recruiting
The First Affiliated Hospital of HaErBin Medical University
Haerbin, Heilongjiang
gongyan chen
xuan hong, 13946066560, hongxuan_1218@sina.com
- Active, not recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang
- Recruiting
The second affiliated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang
kai wang, 86-13957158572, doctorhuxi@163.com
liren ding, 86-13906535702, lirending@zju.edu.cn
- Active, not recruiting
ZheJiang Provincial Tumor Hospital
Hangzhou, Zhejiang
- Recruiting
The First Affiliated Hospital of AnHui Medical University
Hefei, Anhui
yueyin pan, 86-13805695536, yueyinpan@gmail.com
wei huang, 86-13505514938, huangweibsh@163.com
- Recruiting
ShanDong Provincial Tumor Hospital
Jinan, Shandong
qisen guo
yan guan, 15865298279, qhgy219@163.com
- Recruiting
Linyi cancer hospital
Linyi, Shandong
jianhua shi, 86-15963998868, shijianhualy@126.com
shuoxin liu, 86-15969916696, lyzlyygcp@163.com
- Active, not recruiting
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi
- Recruiting
JiangSu Provincial Tumor Hospital
Nanjing, Jiangsu
meiqi shi, 13809029766, shimeiqi1963@163.com
- Recruiting
Cancer Hospital Affiliated To GuangXi Medical University
Nanning, Guangxi
xiangqun song, 86-13877104657, xiangquns@163.com
shaozhang zhou, 86-18677115144, zhoushaozhang@qq.com
- Recruiting
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality
chong bai
huijie zhang, 18621775835, 15236196601@163.com
- Active, not recruiting
East Hospital Affiliated To Tongji University
Shanghai, Shanghai Municipality
- Recruiting
Shanghai Chest hospital of Shanghai Jiaotong University
Shanghai, Shanghai Municipality
Shun Lu, MD, 86 13601813062, shun_lu@hotmail.com
Zhiwei Chen, 86 13916251926, drchenzhiwei@163.com
- Active, not recruiting
LiaoNing Provincial Tumor Hospital
Shenyang, Liaoning
- Recruiting
Fourth hospital of hebei medical university
Shijiazhuang, Hebei
cuimin ding, 86-13933083069, wjwdcm@sina.com
ruijuan li, 86-18231196950, lrj0310@sina.com
- Recruiting
WuHan Tongji Hospital
Wuhan, Hubei
yuan chen
qian chu, qianchu@tjh.tjmu.edu.cn
- Recruiting
HeNan Provincial Tumor Hospital
Zhengzhou, Henan
zhiyong Ma
xiangtao Yan, 18638628118, skyliuyun@126.com
About this study
Official title: Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer: a Multi-center, Randomized, Open Label Study
This study is aimed to evaluate the progression-free survival(PFS) and also survival of IP and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer and to explore the reasonable first-line therapy for Chinese population. An open-label, multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio with an estimation of 308 eligible participants.
Read the detailed description
evaluate the progression-free survival(PFS) and also survival of IP and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer and to explore the reasonable first-line therapy for Chinese population.
An open-label, multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio with an estimation of 308 eligible participants.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Irinotecan, Etoposide, Cisplatin
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Also called Ai Li
40mg
EtoposideDrug
Also called H32025583
5ml：0.1g
CisplatinDrug
Also called Nuo Xin
6ml：30mg
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan plus Cisplatin | Experimental | first line: irinotecan 65mg/m2 d1,8. Cisplatin 30mg/m2，d1,8, 21days/cycle×6 cycles Second-line: etoposide alone OR etoposide plus cisplatin, dosage will be same as first line or on investigator's discretion. Receives: Drug: Irinotecan; Drug: Cisplatin |
| Etoposide plus Cisplatin | Experimental | first line: etoposide 60mg/m2 d1-5 Cisplatin 75mg/m2，d1(recommended), or administer three times with same total daily dose , 21days/cycle×6 cycles Second-line: irinotecan alone or irinotecan plus cisplatin, dosage is same as first line or on investigator's discretion. Receives: Drug: Etoposide; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival of first line therapy
Measured: 24 months
Secondary outcomes (4)
Overall survival
Measured: 36 months
Objective Response Rate
Measured: 24 months
Number of patients experience adverse events
Measured: 36 months
Progression free survival of second line therapy
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 posted28 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017 (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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shun Lu, M.D, Principal investigator, Shanghai Chest hospital of Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348450
- Sponsor's protocol ID
- CTONG1404
- Status last verified
- Dec 2016
- First submitted
- 23 Oct 2014
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer: a Multi-center, Randomized, Open Label Study
- ClinicalTrials.gov ID
- NCT02348450
- Acronym / sponsor ID
- CTONG1404
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Jan 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.
This study is aimed to evaluate the progression-free survival(PFS) and also survival of IP and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer and to explore the reasonable first-line therapy for Chinese population. An open-label, multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio with an estimation of 308 eligible participants.
Detailed description
evaluate the progression-free survival(PFS) and also survival of IP and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer and to explore the reasonable first-line therapy for Chinese population.
An open-label, multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio with an estimation of 308 eligible participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irinotecan plus Cisplatin | Experimental | Drug: Irinotecan, Drug: Cisplatinfirst line: irinotecan 65mg/m2 d1,8. Cisplatin 30mg/m2，d1,8, 21days/cycle×6 cycles Second-line: etoposide alone OR etoposide plus cisplatin, dosage will be same as first line or on investigator's discretion. |
| Etoposide plus Cisplatin | Experimental | Drug: Etoposide, Drug: Cisplatinfirst line: etoposide 60mg/m2 d1-5 Cisplatin 75mg/m2，d1(recommended), or administer three times with same total daily dose , 21days/cycle×6 cycles Second-line: irinotecan alone or irinotecan plus cisplatin, dosage is same as first line or on investigator's discretion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Cytologically or histologically confirmed extensive stage small-cell lung cancer (remote metastasis and/or contralateral lymph-node involvement; not those with simple ipsilateral pleural effusion);
- No prior radiotherapy, chemotherapy or surgery;
- At least one measurable lesion, CT≥20mm, spiral CT≥10mm(diameter);
- ECOG PS 0-1;
- Age 18-70;
Key exclusion criteria (16 listed)
- Failed to meet the entry criteria of pathology and clinical stage;
- Have received prior chemotherapy or target treatment;
- Currently receiving other anticancer therapy;
- No measurable lesions or lesions cannot be assessed;
- Patients with acute or chronic medical or psychiatric condition, or laboratory abnormalities that may impact the judgment of the investigator and the result of the study, determined by investigator they may include:
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 |
|---|---|---|
| IrinotecanAlso: Ai Li40mg | Drug | Irinotecan plus Cisplatin |
| EtoposideAlso: H320255835ml：0.1g | Drug | Etoposide plus Cisplatin |
| CisplatinAlso: Nuo Xin6ml：30mg | Drug | Etoposide plus Cisplatin, Irinotecan plus Cisplatin |
Primary outcome
Progression free survival of first line therapy
Time frame: 24 months
4 secondary outcomes
Overall survival
Time frame: 36 months
Objective Response Rate
Time frame: 24 months
Number of patients experience adverse events
Time frame: 36 months
Progression free survival of second line therapy
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- 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.
Shun Lu, M.D principal investigator
Shanghai Chest hospital of Shanghai Jiaotong University
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Irinotecan, Etoposide and Cisplatin in people with Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 20 sites 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 11 inclusion and 16 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 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Shun Lu, M.D (86-13601813062, shun_lu@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 of first line therapy (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 5 Dec 2016.