Stage Ib Lung CarcinomaPhase 3NCT02281708
Multicenter Randomized Controlled Trial Adjuvant Chemotherapy vs Observation in pStage Ib Lung Adenocarcinoma
A Phase 3 study testing vinorelbine plus cisplatin in people with Stage Ib Lung Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Researchers developed the nomogram which evaluate the risk of recurrence after surgical resection, and found that the stage 1 NSCLC patients with more than 104 point of nomogram showed similar recurrence rate to the recurrence rate of stage 2 NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stage Ib Lung Carcinoma
- What is being tested?
- vinorelbine plus cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,012 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Sep 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet ALL of the following criteria in order to be eligible for this study
- Age ≥18 years and Age <80
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- The pathological stage Ib adenocarcinoma after complete resection (AJCC 7th). (Patients with adenocarcinoma in situ are excluded)
- Patients must have undergone pulmonary resection more than lobectomy (lobectomy, bilobectomy, pneumonectomy).
- Patients must have undergone either mediastinal lymph node dissection or systemic sampling.
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- Tumor must be resected completely without gross or microscopic residual tumor.
- The interval between surgery for lung cancer and randomization must be no more than 8 weeks.
- The patients must be willing and sign informed consent prior to randomization.
- Patients with appropriate bone marrow function. ANC ≥1,500/uL, hemoglobin ≥9.0g/dL (can be corrected by transfusion). platelet ≥100,000/uL
- Patients with appropriate renal function Serum creatinine ≤ 1 x UNL(upper limit or normal) or Estimated creatinine clearance ≥ 45 ml/min
- Patients with appropriate liver function Serum bilirubin ≤ 1.5 x UNL, AST (SGOT) and ALT (SGPT) ≤ 3 x UNL, alkaline phosphatase ≤ 3 x UNL
Who cannot join
- Patients meeting any ONE of the following criteria are not eligible for this study.
- Other concurrent serious diseases that may interfere with planned treatment.
- Pregnant of lactation women
- Women of childbearing potential without a negative pregnant test (urine HCG), within 14 days prior to randomization or less than one year after menopause.
- Any previous systemic chemotherapy for cancer or anti-cancer immunotherapy.
- History of non-lung malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, melanoma in situ.
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- Serious cardiac illness or medical conditions including uncontrolled hypertension, myocardial infarction within 6 months, unstable angina pectoris, heart failure >NYHA grad II, or uncontrolled arrhythmia.
- Patients with sensitivity to vinorelbine or cisplatin.
- Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Sanghoon Jheon, Ph.D., 82317877140, jheon@snubh.org
About this study
Official title: A Multi-center Phase III Randomized Controlled Trial Comparing Between Adjuvant Chemotherapy and Observation in High Risk Patients With Completely Resected Stage Ib Lung Adenocarcinoma
Researchers developed the nomogram which evaluate the risk of recurrence after surgical resection, and found that the stage 1 NSCLC patients with more than 104 point of nomogram showed similar recurrence rate to the recurrence rate of stage 2 NSCLC patients. Thus those stage 1 NSCLC patients at high recurrence rate are considered to show positive effect of adjuvant chemotherapy and perform the study to prove this hypothesis.
Applying the nomogram, the patient scored lower than 104 is categorized into low risk group and is to be grouped as the observation group which adjuvant chemotherapy will not be given. The high risk group patients (the nomogram scored larger than 104) are randomly divided into the treatment group and the observation group. Then, the clinical result on the recurrence between the observation group and the treatment group will be compared.
Read more
- Regimen of the adjuvant chemotherapy: The most commonly used 1st line chemotherapy regimen which is vinorelbine plus cisplatin will be admitted for 4 cycles. Also the three days before and the after the estimated day are permitted as allowance.
Intravenous administration of vinorelbine (25mg/m2), the 1st and the 8th day of the each cycle, every 3 weeks.
Intravenous administration of cisplatin (75mg/m2), the 1st day of the each cycle, every 3 weeks.
Read the detailed description
Enrolled stage 1B adenocarcinoma patient will be registered for the study and be randomly allocated to the treatment group and the observation group by the stratification factor; the institution. Each group is determined to have same number of study population. This study is open labeled and follow the permuted block design. Also the patients will be allocated by randomized table provided by a statistician. If it is converted to e-CRF, randomization of the patients will be performed by the automated computer program.
Total 1012 patients will be enrolled to this study. Among 506 high risk stage 1B adenocarcinoma patients, patients will be allocated to the treatment and the observation groups, 253 patients each. Also 506 low risk stage 1B adenocarcinoma patients will be enrolled as the observation group. Because, among stage 1B patients, it was revealed that the high risk patients whose nomogram point exceeds 104 occupied about 50% in analysis.
Estimated 3 year disease free survival for the treatment group and the observation group is 66% and 54%, respectively. The 3 year disease free survival rate for the observation group was estimated based on retrospective multicenter study on 1132 stage 1 NSCLC patients, previously reported in Korea. During the 3 year of follow up duration, the withdrawal rate was presumed to be 10% because of loss of follow-up, violation of the consent and other causes. Study population enrollment is estimated as 48 months and mean follow-up duration is estimated as 24 months. Total duration of the study is set as 72 months. In this study design, the number of the high risk patients of each group is 253 and it supports 80% power of test with a two-sided alpha level of 0.05.
- Conditions
- Stage Ib Lung Carcinoma
- Being tested
- vinorelbine plus cisplatin
- Keywords
- normogram, recurrence, adjuvant chemotherapy, disease free survival, Quality of life
- Medical subject headings
- Lung Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vinorelbine plus cisplatinDrug
Also called Navelbine (cisplatin) plus DDP
Drugs will be administered for 4 cycles, and should be administered at scheduled day +/- 3 days
- vinorelbine 25mg/m2 IV (Day 1, 8) q 3wks cisplatin 75mg/m2 IV (Day 1) q 3wks
| Study group | Role | What they receive |
|---|---|---|
| low risk | No intervention | low risk; observation |
| high risk; observation group | No intervention | high risk: observation |
| high risk; adjuvant chemotherapy group | Experimental | high risk. vinorelbine plus cisplatin Receives: Drug: vinorelbine plus cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival (DFS)
the time between the operation and the date of treatment for recurred lung cancer or suspected recurrence
Measured: 3 year
Secondary outcomes (2)
overall survival rate (OS)
the time between the operation and death from any cause
Measured: 3 year, 5 year
quality-of-life (QoL)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2018 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stage Ib Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 1,012 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanghoon Jheon, Seoul National University Hospital
- Investigators
- Sanghoon Jheon, Ph.D., Study director, Seoul National Univsersity Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281708
- Sponsor's protocol ID
- CRO
- Status last verified
- Oct 2014
- First submitted
- 30 Oct 2014
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hung JJ, Jeng WJ, Chou TY, Hsu WH, Wu KJ, Huang BS, Wu YC. Prognostic value of the new International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society lung adenocarcinoma classification on death and recurrence in completely resected stage I lung adenocarcinoma. Ann Surg. 2013 Dec;258(6):1079-86. doi: 10.1097/SLA.0b013e31828920c0.
PubMed 23532112Okada M, Nakayama H, Okumura S, Daisaki H, Adachi S, Yoshimura M, Miyata Y. Multicenter analysis of high-resolution computed tomography and positron emission tomography/computed tomography findings to choose therapeutic strategies for clinical stage IA lung adenocarcinoma. J Thorac Cardiovasc Surg. 2011 Jun;141(6):1384-91. doi: 10.1016/j.jtcvs.2011.02.007. Epub 2011 Mar 25.
PubMed 21440264Kim HR, Kim DJ, Lee WW, Jheon S, Sung SW. The significance of maximum standardized uptake values in patients with stage I pulmonary adenocarcinoma. Eur J Cardiothorac Surg. 2009 Apr;35(4):712-6; discussion 716-7. doi: 10.1016/j.ejcts.2008.12.030. Epub 2009 Feb 10.
PubMed 19211260Strauss GM, Herndon JE 2nd, Maddaus MA, Johnstone DW, Johnson EA, Harpole DH, Gillenwater HH, Watson DM, Sugarbaker DJ, Schilsky RL, Vokes EE, Green MR. Adjuvant paclitaxel plus carboplatin compared with observation in stage IB non-small-cell lung cancer: CALGB 9633 with the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and North Central Cancer Treatment Group Study Groups. J Clin Oncol. 2008 Nov 1;26(31):5043-51. doi: 10.1200/JCO.2008.16.4855. Epub 2008 Sep 22.
PubMed 18809614Cerfolio RJ, Bryant AS, Ohja B, Bartolucci AA. The maximum standardized uptake values on positron emission tomography of a non-small cell lung cancer predict stage, recurrence, and survival. J Thorac Cardiovasc Surg. 2005 Jul;130(1):151-9. doi: 10.1016/j.jtcvs.2004.11.007.
PubMed 15999056Ohtsuka T, Nomori H, Watanabe K, Kaji M, Naruke T, Suemasu K, Uno K. Prognostic significance of [(18)F]fluorodeoxyglucose uptake on positron emission tomography in patients with pathologic stage I lung adenocarcinoma. Cancer. 2006 Nov 15;107(10):2468-73. doi: 10.1002/cncr.22268.
PubMed 17036361Yoshizawa A, Motoi N, Riely GJ, Sima CS, Gerald WL, Kris MG, Park BJ, Rusch VW, Travis WD. Impact of proposed IASLC/ATS/ERS classification of lung adenocarcinoma: prognostic subgroups and implications for further revision of staging based on analysis of 514 stage I cases. Mod Pathol. 2011 May;24(5):653-64. doi: 10.1038/modpathol.2010.232. Epub 2011 Jan 21.
PubMed 21252858
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Phase III Randomized Controlled Trial Comparing Between Adjuvant Chemotherapy and Observation in High Risk Patients With Completely Resected Stage Ib Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02281708
- Acronym / sponsor ID
- CRO
- Conditions
- Stage Ib Lung Carcinoma
- Keywords
- normogram, recurrence, adjuvant chemotherapy, disease free survival, Quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,012 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 3 Nov 2014 (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.
Researchers developed the nomogram which evaluate the risk of recurrence after surgical resection, and found that the stage 1 NSCLC patients with more than 104 point of nomogram showed similar recurrence rate to the recurrence rate of stage 2 NSCLC patients. Thus those stage 1 NSCLC patients at high recurrence rate are considered to show positive effect of adjuvant chemotherapy and perform the study to prove this hypothesis.
Applying the nomogram, the patient scored lower than 104 is categorized into low risk group and is to be grouped as the observation group which adjuvant chemotherapy will not be given. The high risk group patients (the nomogram scored larger than 104) are randomly divided into the treatment group and the observation group. Then, the clinical result on the recurrence between the observation group and the treatment group will be compared.
- Regimen of the adjuvant chemotherapy: The most commonly used 1st line chemotherapy regimen which is vinorelbine plus cisplatin will be admitted for 4 cycles. Also the three days before and the after the estimated day are permitted as allowance.
Intravenous administration of vinorelbine (25mg/m2), the 1st and the 8th day of the each cycle, every 3 weeks.
Intravenous administration of cisplatin (75mg/m2), the 1st day of the each cycle, every 3 weeks.
Detailed description
Enrolled stage 1B adenocarcinoma patient will be registered for the study and be randomly allocated to the treatment group and the observation group by the stratification factor; the institution. Each group is determined to have same number of study population. This study is open labeled and follow the permuted block design. Also the patients will be allocated by randomized table provided by a statistician. If it is converted to e-CRF, randomization of the patients will be performed by the automated computer program.
Total 1012 patients will be enrolled to this study. Among 506 high risk stage 1B adenocarcinoma patients, patients will be allocated to the treatment and the observation groups, 253 patients each. Also 506 low risk stage 1B adenocarcinoma patients will be enrolled as the observation group. Because, among stage 1B patients, it was revealed that the high risk patients whose nomogram point exceeds 104 occupied about 50% in analysis.
Estimated 3 year disease free survival for the treatment group and the observation group is 66% and 54%, respectively. The 3 year disease free survival rate for the observation group was estimated based on retrospective multicenter study on 1132 stage 1 NSCLC patients, previously reported in Korea. During the 3 year of follow up duration, the withdrawal rate was presumed to be 10% because of loss of follow-up, violation of the consent and other causes. Study population enrollment is estimated as 48 months and mean follow-up duration is estimated as 24 months. Total duration of the study is set as 72 months. In this study design, the number of the high risk patients of each group is 253 and it supports 80% power of test with a two-sided alpha level of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low risk | No intervention | –low risk; observation |
| high risk; observation group | No intervention | –high risk: observation |
| high risk; adjuvant chemotherapy group | Experimental | Drug: vinorelbine plus cisplatinhigh risk. vinorelbine plus cisplatin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must meet ALL of the following criteria in order to be eligible for this study
- Age ≥18 years and Age <80
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- The pathological stage Ib adenocarcinoma after complete resection (AJCC 7th). (Patients with adenocarcinoma in situ are excluded)
- Patients must have undergone pulmonary resection more than lobectomy (lobectomy, bilobectomy, pneumonectomy).
Key exclusion criteria (9 listed)
- Patients meeting any ONE of the following criteria are not eligible for this study.
- Other concurrent serious diseases that may interfere with planned treatment.
- Pregnant of lactation women
- Women of childbearing potential without a negative pregnant test (urine HCG), within 14 days prior to randomization or less than one year after menopause.
- Any previous systemic chemotherapy for cancer or anti-cancer immunotherapy.
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 |
|---|---|---|
| vinorelbine plus cisplatinAlso: Navelbine (cisplatin) plus DDPDrugs will be administered for 4 cycles, and should be administered at scheduled day +/- 3 days * vinorelbine 25mg/m2 IV (Day 1, 8) q 3wks cisplatin 75mg/m2 IV (Day 1) q 3wks | Drug | high risk; adjuvant chemotherapy group |
Primary outcome
disease-free survival (DFS)
Time frame: 3 year
the time between the operation and the date of treatment for recurred lung cancer or suspected recurrence
2 secondary outcomes
overall survival rate (OS)
Time frame: 3 year, 5 year
quality-of-life (QoL)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
- Background: PubMed 23532112Hung JJ, Jeng WJ, Chou TY, Hsu WH, Wu KJ, Huang BS, Wu YC. Prognostic value of the new International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society lung adenocarcinoma classification on death and recurrence in completely resected stage I lung adenocarcinoma. Ann Surg. 2013 Dec;258(6):1079-86. doi: 10.1097/SLA.0b013e31828920c0.
- Background: PubMed 21440264Okada M, Nakayama H, Okumura S, Daisaki H, Adachi S, Yoshimura M, Miyata Y. Multicenter analysis of high-resolution computed tomography and positron emission tomography/computed tomography findings to choose therapeutic strategies for clinical stage IA lung adenocarcinoma. J Thorac Cardiovasc Surg. 2011 Jun;141(6):1384-91. doi: 10.1016/j.jtcvs.2011.02.007. Epub 2011 Mar 25.
- Background: PubMed 19211260Kim HR, Kim DJ, Lee WW, Jheon S, Sung SW. The significance of maximum standardized uptake values in patients with stage I pulmonary adenocarcinoma. Eur J Cardiothorac Surg. 2009 Apr;35(4):712-6; discussion 716-7. doi: 10.1016/j.ejcts.2008.12.030. Epub 2009 Feb 10.
- Background: PubMed 18809614Strauss GM, Herndon JE 2nd, Maddaus MA, Johnstone DW, Johnson EA, Harpole DH, Gillenwater HH, Watson DM, Sugarbaker DJ, Schilsky RL, Vokes EE, Green MR. Adjuvant paclitaxel plus carboplatin compared with observation in stage IB non-small-cell lung cancer: CALGB 9633 with the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and North Central Cancer Treatment Group Study Groups. J Clin Oncol. 2008 Nov 1;26(31):5043-51. doi: 10.1200/JCO.2008.16.4855. Epub 2008 Sep 22.
- Background: PubMed 15999056Cerfolio RJ, Bryant AS, Ohja B, Bartolucci AA. The maximum standardized uptake values on positron emission tomography of a non-small cell lung cancer predict stage, recurrence, and survival. J Thorac Cardiovasc Surg. 2005 Jul;130(1):151-9. doi: 10.1016/j.jtcvs.2004.11.007.
- Background: PubMed 17036361Ohtsuka T, Nomori H, Watanabe K, Kaji M, Naruke T, Suemasu K, Uno K. Prognostic significance of [(18)F]fluorodeoxyglucose uptake on positron emission tomography in patients with pathologic stage I lung adenocarcinoma. Cancer. 2006 Nov 15;107(10):2468-73. doi: 10.1002/cncr.22268.
- Results publication: PubMed 21252858Yoshizawa A, Motoi N, Riely GJ, Sima CS, Gerald WL, Kris MG, Park BJ, Rusch VW, Travis WD. Impact of proposed IASLC/ATS/ERS classification of lung adenocarcinoma: prognostic subgroups and implications for further revision of staging based on analysis of 514 stage I cases. Mod Pathol. 2011 May;24(5):653-64. doi: 10.1038/modpathol.2010.232. Epub 2011 Jan 21.
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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.
Sanghoon Jheon, Ph.D. study director
Seoul National Univsersity Bundang 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 vinorelbine plus cisplatin in people with Stage Ib Lung Carcinoma, run by Seoul 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 12 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 3 Nov 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanghoon Jheon, Ph.D. (82317877140, jheon@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (DFS) (time frame: 3 year). 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 NCT02281708, which also lists 7 linked publications.
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 3 Nov 2014.