Carcinoma, Non-Small-Cell LungPhase 3NCT00326378
Efficacy Study of Additional Chemotherapy After Concurrent Chemoradiation in Non-small Cell Lung Cancer
A Phase 3 study testing consolidation chemotherapy with Docetaxel plus cisplatin and CCRT arm without consolidation chemotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Non-Small Cell Lung Cancer(NSCLC) is the leading cause of death in Korean men after stomach cancer. Surgical resection plays a main role for curative treatment. However, less than 20 % of the NSCLC patients have been found in stage I-II disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- consolidation chemotherapy with Docetaxel plus cisplatin and CCRT arm without consolidation chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2005to May 2015
- 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 proven non-small cell lung cancer
- Presence of measurable disease by RECIST
- Inoperable Stage IIIA or IIIB, proven by CT or MRI (except wet T4). However, N2 or N3 should be confirmed by PET or pathology. (For T4, PET is optional)
- 18 years of age or older
- ECOG Performance status 0-1
- No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
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- Serum Hgb ≥ 10 gm/dL, platelet ≥ 100,000/μL, absolute neutrophil count ≥ 1,500/μL
- Serum creatinine ≤1.25 x UNL or creatinine clearance ≥60 mlmL/min
- Serum bilirubin ≤ 1.5 x UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL, alkaline phosphatase ≤ 5 x UNL
- FEV1> 0.8 L
- Patients must sign an informed consent
Who cannot join
- Carcinoid tumor, small cell carcinoma of lung
- Patients with any distant metastasis
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
- Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women
- Women and men of childbearing potential who have no willing of employing adequate contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multinational, Multicenter, Phase III Open Randomized Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-small Cell Lung Cancer (CCheIN)
Non-Small Cell Lung Cancer(NSCLC) is the leading cause of death in Korean men after stomach cancer. Surgical resection plays a main role for curative treatment. However, less than 20 % of the NSCLC patients have been found in stage I-II disease. In inoperable stage IIIA/B disease, the recommended treatment is combined chemotherapy and radiation therapy. Various kinds of combination of 2 modalities have been used either in sequential or concurrent setting. Concurrent chemoradiotherapy(CCRT) have been recognized to have better survival than radiation therapy alone or sequential therapy, but additional consolidation chemotherapy after CCRT is not yet to be determined for the beneficial role in survival gain. Docetaxel is an anticancer drug and has synergistic anticancer effect in various cancer with cisplatin, another anticancer drug. In the present study, randomised trial will be performed to confirm the efficacy of the consolidation chemotherapy with docetaxel and cisplatin after completing CCRT with the same chemotherapeutic agents in stage III inoperable NSCLC on progression free survival and overall survival.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- consolidation chemotherapy with Docetaxel plus cisplatin, CCRT arm without consolidation chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consolidation chemotherapy with Docetaxel plus cisplatinDrug
definitive CCRT, and followed by consolidation chemotherapy with three cycles of docetaxel plus cisplatin
CCRT arm without consolidation chemotherapyDrug
definitive CCRT with weekly Docetaxel/CDDP #6 without consolidation chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| CCRT arm without consolidation chemotherapy | Active comparator | Docetaxel 20mg/m2 \& Cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy Receives: Drug: CCRT arm without consolidation chemotherapy |
| CCRT arm with consolidation chemotherapy | Experimental | docetaxel 20mg/m2 \& cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy, and followed by consolidation chemotherapy with 3-weekly docetaxel 35mg/m2 \& cisplatin 35mg/m2 (D1,8) every 3 weeks (#3). Receives: Drug: consolidation chemotherapy with Docetaxel plus cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
Secondary outcomes (4)
overall survival
Measured: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
response rate
Measured: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
patterns of failure
Measured: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
safety
Measured: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startOct 2005
- Primary completionMar 2013
- Study completionMay 2015
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, Non-Small-Cell LungStudies 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
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Keunchil Park, Samsung Medical Center
- Investigators
- Keunchil Park, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326378
- Sponsor's protocol ID
- 2005-08-066
- Status last verified
- Nov 2012
- First submitted
- 15 May 2006
- Last updated
- 8 Jun 2015
- Results posted
- No
Publications
Ahn JS, Ahn YC, Kim JH, Lee CG, Cho EK, Lee KC, Chen M, Kim DW, Kim HK, Min YJ, Kang JH, Choi JH, Kim SW, Zhu G, Wu YL, Kim SR, Lee KH, Song HS, Choi YL, Sun JM, Jung SH, Ahn MJ, Park K. Multinational Randomized Phase III Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-Small-Cell Lung Cancer: KCSG-LU05-04. J Clin Oncol. 2015 Aug 20;33(24):2660-6. doi: 10.1200/JCO.2014.60.0130. Epub 2015 Jul 6.
PubMed 26150444
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Phase III Open Randomized Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-small Cell Lung Cancer (CCheIN)
- ClinicalTrials.gov ID
- NCT00326378
- Acronym / sponsor ID
- 2005-08-066
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Oct 2005
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 May 2006 (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(NSCLC) is the leading cause of death in Korean men after stomach cancer. Surgical resection plays a main role for curative treatment. However, less than 20 % of the NSCLC patients have been found in stage I-II disease. In inoperable stage IIIA/B disease, the recommended treatment is combined chemotherapy and radiation therapy. Various kinds of combination of 2 modalities have been used either in sequential or concurrent setting. Concurrent chemoradiotherapy(CCRT) have been recognized to have better survival than radiation therapy alone or sequential therapy, but additional consolidation chemotherapy after CCRT is not yet to be determined for the beneficial role in survival gain. Docetaxel is an anticancer drug and has synergistic anticancer effect in various cancer with cisplatin, another anticancer drug. In the present study, randomised trial will be performed to confirm the efficacy of the consolidation chemotherapy with docetaxel and cisplatin after completing CCRT with the same chemotherapeutic agents in stage III inoperable NSCLC on progression free survival and overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCRT arm without consolidation chemotherapy | Active comparator | Drug: CCRT arm without consolidation chemotherapyDocetaxel 20mg/m2 \& Cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy |
| CCRT arm with consolidation chemotherapy | Experimental | Drug: consolidation chemotherapy with Docetaxel plus cisplatindocetaxel 20mg/m2 \& cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy, and followed by consolidation chemotherapy with 3-weekly docetaxel 35mg/m2 \& cisplatin 35mg/m2 (D1,8) every 3 weeks (#3). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically proven non-small cell lung cancer
- Presence of measurable disease by RECIST
- Inoperable Stage IIIA or IIIB, proven by CT or MRI (except wet T4). However, N2 or N3 should be confirmed by PET or pathology. (For T4, PET is optional)
- 18 years of age or older
- ECOG Performance status 0-1
Key exclusion criteria (6 listed)
- Carcinoid tumor, small cell carcinoma of lung
- Patients with any distant metastasis
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
- Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women
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 |
|---|---|---|
| consolidation chemotherapy with Docetaxel plus cisplatindefinitive CCRT, and followed by consolidation chemotherapy with three cycles of docetaxel plus cisplatin | Drug | CCRT arm with consolidation chemotherapy |
| CCRT arm without consolidation chemotherapydefinitive CCRT with weekly Docetaxel/CDDP #6 without consolidation chemotherapy | Drug | CCRT arm without consolidation chemotherapy |
Primary outcome
Progression free survival
Time frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
4 secondary outcomes
overall survival
Time frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
response rate
Time frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
patterns of failure
Time frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
safety
Time frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
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 8 Jun 2015.
- Derived from this study: PubMed 26150444Ahn JS, Ahn YC, Kim JH, Lee CG, Cho EK, Lee KC, Chen M, Kim DW, Kim HK, Min YJ, Kang JH, Choi JH, Kim SW, Zhu G, Wu YL, Kim SR, Lee KH, Song HS, Choi YL, Sun JM, Jung SH, Ahn MJ, Park K. Multinational Randomized Phase III Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-Small-Cell Lung Cancer: KCSG-LU05-04. J Clin Oncol. 2015 Aug 20;33(24):2660-6. doi: 10.1200/JCO.2014.60.0130. Epub 2015 Jul 6.
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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, M.D. principal investigator
Samsung Medical Center
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 consolidation chemotherapy with Docetaxel plus cisplatin and CCRT arm without consolidation chemotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Samsung Medical Center 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 11 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 8 Jun 2015. 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?
Progression free survival (time frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed.). 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 NCT00326378, 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 8 Jun 2015.