Small Cell Lung CancerPhase 3NCT01125995
Early Versus Late Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer
A Phase 3 study testing early CCRT and late CCRT in people with Small Cell Lung Cancer, run by Samsung Medical Center at 2 sites in South Korea.
Trial summary
The purpose of the study is to evaluate the efficacy and toxicity of different timing of concurrent chemoradiation in the treatment of limited disease status Small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- early CCRT and late CCRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jun 2003to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed small-cell lung cancer
- limited disease status
- with evaluable disease
- 18 years or older
- ECOG performance status 0,1,2
- expected survival time should be 12 weeks or longer
- Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min
- Written informed consent form
Who cannot join
- Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
- Patients with active infection requiring antibiotics
- Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
- Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
- previous history of chemotherapy or radiotherapy
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized Phase III Trial for Timing of Radiation in Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer
The purpose of the study is to evaluate the efficacy and toxicity of different timing of concurrent chemoradiation in the treatment of limited disease status Small-cell lung cancer.
- Conditions
- Small Cell Lung Cancer
- Being tested
- early CCRT, late CCRT
- Keywords
- limited disease
- 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.
early CCRTRadiation
- patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 \& Cisplatin 70mg/m2 D1.
- radiotherapy start from day 1 of 1st chemotherapy cycle and complete 5250cGy/25fraction (daily one fraction, 210cGy).
late CCRTRadiation
- patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 \& Cisplatin 70mg/m2 D1.
- radiotherapy start from day 1 of the third cycle of EP chemotherapy and complete 5250cGy/25fraction (daily one fraction, 210cGy).
| Study group | Role | What they receive |
|---|---|---|
| late CCRT | Active comparator | radiotherapy start on day one of the third cycle of chemotherapy Receives: Radiation: late CCRT |
| Early CCRT | Experimental | Radiotherapy start on day 1 of 1st cycle of chemotherapy Receives: Radiation: early CCRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate
Measured: 6 months
Secondary outcomes (4)
overall survival
Measured: 36 months
objective response rate
Measured: 6 months
Progression-free survival
Measured: 36 months
toxicity by NCI common toxicity version 2.0
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startJun 2003
- Primary completionJul 2011
- Study completionMay 2013
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.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keunchil Park, Samsung Medical Center
- Investigators
- Keunchil Park, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125995
- Sponsor's protocol ID
- 2003-02-016
- Status last verified
- May 2013
- First submitted
- 17 May 2010
- Last updated
- 30 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial for Timing of Radiation in Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01125995
- Acronym / sponsor ID
- 2003-02-016
- Conditions
- Small Cell Lung Cancer
- Keywords
- limited disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Jul 2011 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 19 May 2010 (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.
The purpose of the study is to evaluate the efficacy and toxicity of different timing of concurrent chemoradiation in the treatment of limited disease status Small-cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| late CCRT | Active comparator | Radiation: late CCRTradiotherapy start on day one of the third cycle of chemotherapy |
| Early CCRT | Experimental | Radiation: early CCRTRadiotherapy start on day 1 of 1st cycle of chemotherapy |
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 confirmed small-cell lung cancer
- limited disease status
- with evaluable disease
- 18 years or older
- ECOG performance status 0,1,2
Key exclusion criteria (5 listed)
- Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
- Patients with active infection requiring antibiotics
- Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
- Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
- previous history of chemotherapy or radiotherapy
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 |
|---|---|---|
| early CCRT1. patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 \& Cisplatin 70mg/m2 D1. 2. radiotherapy start from day 1 of 1st chemotherapy cycle and complete 5250cGy/25fraction (daily one fraction, 210cGy). | Radiation | Early CCRT |
| late CCRT1. patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 \& Cisplatin 70mg/m2 D1. 2. radiotherapy start from day 1 of the third cycle of EP chemotherapy and complete 5250cGy/25fraction (daily one fraction, 210cGy). | Radiation | late CCRT |
Primary outcome
complete response rate
Time frame: 6 months
4 secondary outcomes
overall survival
Time frame: 36 months
objective response rate
Time frame: 6 months
Progression-free survival
Time frame: 36 months
toxicity by NCI common toxicity version 2.0
Time frame: 36 months
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 30 May 2013.
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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.
Keunchil Park principal investigator
Samsung Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing early CCRT and late CCRT in people with Small Cell Lung Cancer, run by Samsung Medical Center at 2 sites 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 8 inclusion and 5 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 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
complete response rate (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 30 May 2013.