Limited Disease Small Cell Lung CancerPhase 2NCT01710956
Once Daily Accelerated Fractionation With Concomitant Boost to the Gross Tumor Volume Compared With Twice Daily Hyperfractionation in Concurrent Chemoradiation in Patients With Limited Disease Small Cell Lung Cancer
A Phase 2 study testing Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy in people with Limited Disease Small Cell Lung Cancer, run by National Cancer Center, Korea at 2 sites in South Korea.
Trial summary
Non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limited Disease Small Cell Lung Cancer
- What is being tested?
- Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Mar 2011to Dec 2014
- 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
- Histologically or cytologically (if cannot be proven histologically, at least twice positive findings on fine needle aspiration or sputum cytology) confirmed SCLC
- Limited stage (Clinical stage I-IIIb, lesion limited to one side of thorax, e.g. Excluding T4 disease with malignant pleural effusion or N3 disease with contralateral hilum/supraclavicular lymph node invasion).
- Measurable or assessable lesion
- Age over 18 years old
- Performance status (ECOG scale): 0~2
- Adequate organ functions: ANC ≥ 1500/ul, PLT ≥ 100 x 103/u, Total Bilirubin ≤ 1.5 mg/dl, Creatinine ≤ 1.5 mg/dl
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- Inclusion of tumor within the limited radiation field without significant loss of pulmonary function (confirmed by radiation oncologist)
- Sexually active fertile men and women using a contraceptive method
- Patients should sign a written informed consest before study entry
Who cannot join
- T4 disease with malignant pleural effusion; N3 disease with contralateral hilum/supraclavicular lymph node invasion
- Lesion with mixed small cell nonsmall cell feature (pathologically)
- prior chemotherapy or radiation therapy.
- Pericardial or pleural effusion on chest X-ray image regardless of cytological finding
- T4 disease with tumor invasion to great vessels, heart, trachea, or esophagus; Concerns about possible perforation by tumor necrosis
- Severe comorbidities such as cardiac disease with symptom, myocardiac infarction within 6 months, chronic obstructive pulmonary disease with FEV1 less than 1.0ℓ, or uncontrolled bronchospasm of unaffected lung
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- With atelectasis that makes GTV unidentifiable
- Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 3 years ago without recurrence)
- Uncontrolled psychiatric disorder, serious head injury, chronic alcoholism, drug addiction and central nervous system disease
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
National Cancer Canter, Korea
Ilsan-ro 323, Ilsandoung-gu, Goyang-si, Gyeonggi-do, 410-769
Kwan Ho Cho, M.D., +82 31 920 1720, ncckrog@ncc.re.kr
Sung Ho Moon, M.D., +82 31 920 1726, ncckrog@ncc.re.kr
- Recruiting
National Cancer Canter, Korea
Ilsan-ro 323, Ilsandoung-gu, Goyang-si, Gyeonggi-do, 410-769
Kwan Ho Cho, M.D., +82 31 920 1720, kwancho@ncc.re.kr
Sung Ho Moon, M.D., +82 31 920 1726, shmoon@ncc.re.kr
About this study
Official title: Randomized Phase II Study of Once Daily Accelerated Fractionation With Concomitant Boost to the Gross Tumor Volume Compared With Twice Daily Hyperfractionation in Concurrent Chemoradiation in Patients With Limited Disease Small Cell Lung Cancer
Non-small cell lung cancer
- Conditions
- Limited Disease Small Cell Lung Cancer
- Being tested
- Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy
- Keywords
- concurrent chemoradiation in patients with limited disease small cell lung cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapyRadiation
Arm 1: with twice-daily thoracic radiotherapy daily 1.5gy/fr. bid, total 45gy(30fr during 3weeks) Arm 2: with once-daily thoracic radiotherapy daily 2.4gy/fr. qd, total 60gy(25fr during 5weeks)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1(with twice-daily TRT) | Experimental | Not described Receives: Radiation: Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy |
| Arm 2 (with once-daily TRT) | Experimental | Not described Receives: Radiation: Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 5years after chemoradiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startMar 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited Disease 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kwan Ho Cho, National Cancer Center, Korea
- Investigators
- Kwan Ho Cho, M.D., Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710956
- Sponsor's protocol ID
- NCCCTS-11-531
- Status last verified
- Oct 2012
- First submitted
- 16 Oct 2012
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Once Daily Accelerated Fractionation With Concomitant Boost to the Gross Tumor Volume Compared With Twice Daily Hyperfractionation in Concurrent Chemoradiation in Patients With Limited Disease Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01710956
- Acronym / sponsor ID
- NCCCTS-11-531
- Conditions
- Limited Disease Small Cell Lung Cancer
- Keywords
- concurrent chemoradiation in patients with limited disease small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Mar 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 19 Oct 2012 (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.
Non-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 |
|---|---|---|
| Arm 1(with twice-daily TRT) | Experimental | Radiation: Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy |
| Arm 2 (with once-daily TRT) | Experimental | Radiation: Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically (if cannot be proven histologically, at least twice positive findings on fine needle aspiration or sputum cytology) confirmed SCLC
- Limited stage (Clinical stage I-IIIb, lesion limited to one side of thorax, e.g. Excluding T4 disease with malignant pleural effusion or N3 disease with contralateral hilum/supraclavicular lymph node invasion).
- Measurable or assessable lesion
- Age over 18 years old
- Performance status (ECOG scale): 0~2
Key exclusion criteria (9 listed)
- T4 disease with malignant pleural effusion; N3 disease with contralateral hilum/supraclavicular lymph node invasion
- Lesion with mixed small cell nonsmall cell feature (pathologically)
- prior chemotherapy or radiation therapy.
- Pericardial or pleural effusion on chest X-ray image regardless of cytological finding
- T4 disease with tumor invasion to great vessels, heart, trachea, or esophagus; Concerns about possible perforation by tumor necrosis
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 |
|---|---|---|
| Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapyArm 1: with twice-daily thoracic radiotherapy daily 1.5gy/fr. bid, total 45gy(30fr during 3weeks) Arm 2: with once-daily thoracic radiotherapy daily 2.4gy/fr. qd, total 60gy(25fr during 5weeks) | Radiation | Arm 1(with twice-daily TRT), Arm 2 (with once-daily TRT) |
Primary outcome
progression free survival
Time frame: 5years after chemoradiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2012.
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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.
Kwan Ho Cho, M.D. principal investigator
National Cancer Center, Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy in people with Limited Disease Small Cell Lung Cancer, run by National Cancer Center, Korea 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 9 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 19 Oct 2012. 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 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 Kwan Ho Cho, M.D. (+82 31 920 1720, kwancho@ncc.re.kr), 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: 5years after chemoradiotherapy). 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 19 Oct 2012; AzTrials last refreshed its copy on 6 Nov 2026.