Multicenter Randomized Controlled Trial Adjuvant Chemotherapy vs Observation in pStage Ib Lung Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT02281708|
Recruitment Status : Recruiting
First Posted : November 3, 2014
Last Update Posted : November 3, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Stage Ib Lung Carcinoma||Drug: vinorelbine plus cisplatin||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1012 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2020|
No Intervention: low risk
low risk; observation
No Intervention: high risk; observation group
high risk: observation
Experimental: high risk; adjuvant chemotherapy group
high risk. vinorelbine plus cisplatin
Drug: vinorelbine plus cisplatin
Drugs will be administered for 4 cycles, and should be administered at scheduled day +/- 3 days
Other Name: Navelbine (cisplatin) plus DDP
- 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
- overall survival rate (OS) [ Time Frame: 3 year, 5 year ]the time between the operation and death from any cause
- quality-of-life (QoL) [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281708
|Contact: Sanghoon Jheon, Ph.D.||email@example.com|
|Korea, Republic of|
|Seoul National University Bundang Hospital||Recruiting|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707|
|Contact: Sanghoon Jheon, Ph.D. 82317877140 firstname.lastname@example.org|
|Study Director:||Sanghoon Jheon, Ph.D.||Seoul National Univsersity Bundang Hospital|