Carcinoma, Small CellPhase 3COMBATNCT00826644
Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient
A Phase 3 study testing Belotecan, Etoposide and Cisplatin in people with Carcinoma, Small Cell, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Carcinoma, Small Cell
- What is being tested?
- Belotecan, Etoposide and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Feb 2013
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG Performance status 0~2(those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)
- Histologically or cytologically confirmed small cell lung cancer Patient without chemotherapy and radiotherapy
- Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
- Life expectancy of at least 3 months
- Provision of written informed consent
Who cannot join
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease
- Serum bilirubin greater than 3 times the upper limit of reference range(ULRR)
- Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT)greater than 2.5 times ULN if no demonstrable liver metastases (or > 5 times in presence of liver metastases)
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
- Pregnancy or breast-feeding women(women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
- Evidence of brain metastasis
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonnam National University Hwasun Hospital
Hwasun, 58128
About this study
Official title: A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer
Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer.
Primary endpoints
- to assess Response Rate
Secondary endpoints
- to assess Overall response duration, Time to progression, Overall survival
- Conditions
- Carcinoma, Small Cell
- Keywords
- Small cell lung cancer, Camptothecin, Response rate
- Medical subject headings
- Carcinoma, Small Cell, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelotecanDrug
Also called Camtobell
Belotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks
EtoposideDrug
Etoposide 100mg/㎡/day for Day 1 to 3, repeated every 3 weeks
CisplatinDrug
Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Belotecan plus Cisplatin | Experimental | Not described Receives: Drug: Belotecan; Drug: Cisplatin |
| Etoposide plus Cisplatin | Active comparator | Not described Receives: Drug: Etoposide; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer
Measured: two years
Secondary outcomes (3)
to assess the overall response duration
Measured: two years
To assess the time to progression
Measured: two years
to assess the overall survival
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Small CellStudies 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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical
- Responsible party
- Principal investigator, In-Jae, Oh, MD, Chonnam National University Hospital
- Investigators
- In-Jae Oh, M.D.,Ph.D., Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826644
- Sponsor's protocol ID
- CSCLC-0810
- Acronym
- COMBAT
- Status last verified
- Aug 2021
- First submitted
- 21 Jan 2009
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oh IJ, Kim KS, Park CK, Kim YC, Lee KH, Jeong JH, Kim SY, Lee JE, Shin KC, Jang TW, Lee HK, Lee KY, Lee SY. Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial. BMC Cancer. 2016 Aug 26;16(1):690. doi: 10.1186/s12885-016-2741-z.
PubMed 27566413
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00826644
- Acronym / sponsor ID
- COMBAT / CSCLC-0810
- Conditions
- Carcinoma, Small Cell
- Keywords
- Small cell lung cancer, Camptothecin, Response rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical
- Study start
- Jan 2009 (actual)
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Jan 2009 (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.
Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer.
Primary endpoints
- to assess Response Rate
Secondary endpoints
- to assess Overall response duration, Time to progression, Overall survival
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belotecan plus Cisplatin | Experimental | Drug: Belotecan, Drug: Cisplatin |
| Etoposide plus Cisplatin | Active comparator | Drug: Etoposide, Drug: Cisplatin |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ECOG Performance status 0~2(those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)
- Histologically or cytologically confirmed small cell lung cancer Patient without chemotherapy and radiotherapy
- Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
- Life expectancy of at least 3 months
- Provision of written informed consent
Key exclusion criteria (6 listed)
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease
- Serum bilirubin greater than 3 times the upper limit of reference range(ULRR)
- Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT)greater than 2.5 times ULN if no demonstrable liver metastases (or > 5 times in presence of liver metastases)
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
- Pregnancy or breast-feeding women(women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
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 |
|---|---|---|
| BelotecanAlso: CamtobellBelotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks | Drug | Belotecan plus Cisplatin |
| EtoposideEtoposide 100mg/㎡/day for Day 1 to 3, repeated every 3 weeks | Drug | Etoposide plus Cisplatin |
| CisplatinCisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks | Drug | Belotecan plus Cisplatin, Etoposide plus Cisplatin |
Primary outcome
To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer
Time frame: two years
3 secondary outcomes
to assess the overall response duration
Time frame: two years
To assess the time to progression
Time frame: two years
to assess the overall survival
Time frame: two 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 9 Aug 2021.
- Derived from this study: PubMed 27566413Oh IJ, Kim KS, Park CK, Kim YC, Lee KH, Jeong JH, Kim SY, Lee JE, Shin KC, Jang TW, Lee HK, Lee KY, Lee SY. Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial. BMC Cancer. 2016 Aug 26;16(1):690. doi: 10.1186/s12885-016-2741-z.
- 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.
In-Jae Oh, M.D.,Ph.D. principal investigator
Chonnam National University Hospital
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 Belotecan, Etoposide and Cisplatin in people with Carcinoma, Small Cell, run by Chonnam National University Hospital at 1 site in South Korea.
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 6 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 9 Aug 2021. 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 South Korea. 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?
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?
To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00826644, which also lists 1 linked publication.
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 9 Aug 2021.