Stage Ib Lung Carcinoma Clinical Trial
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.
- 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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03870529 -
High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer
|
Early Phase 1 |