UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000810 |
|---|---|
| Receipt number | R000000968 |
| Scientific Title | Phase III study of Carboplatin/Paclitaxel versus UFT for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer |
| Date of disclosure of the study information | 2007/08/28 |
| Last modified on | 2019/08/22 16:00:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase III study of Carboplatin/Paclitaxel versus UFT for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer
Acronym
Phase III study of Carboplatin/Paclitaxel versus UFT for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer
Scientific Title
Phase III study of Carboplatin/Paclitaxel versus UFT for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer
Scientific Title:Acronym
Phase III study of Carboplatin/Paclitaxel versus UFT for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Non Small Cell Lung Cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the efficacy of CBDCA/PTX combined therapy compared to UFT as the post operative adjuvant chemotherapy for completely resected non-small cell lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
adjuvant chemotherapy with CBDCA+PTX
CBDCA: AUC=5, day1
PTX: 175mg/m2 day1
q3-4weeks
Interventions/Control_2
adjuvant chemotherapy with UFT
250mg/m2/day for 2 years
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. pathologically proven non-small cell lung cancer
2. pathological stage IB, II, and stage IIIA with only one station of n2 disease
3. complete resection
4. at least lobectomy
5. adequate LN dissection (ND2a)
6. no prior anti cancer treatment for thoracic malignancy except for this operation
7. PS 0-1
8. adequate organ function for chemotherapy
9. written informed consent
Key exclusion criteria
1. sever infection, uncontrolled Diabetes Mellitus, and hypertension
2. unstable angina or Myocardial Infarction within 6 months
3. apparent interstitial pneumonitis at chest rentogenogram
4. systemic steroid therapy required
5. uncontrolled cancer
6. Pregnant or expecting woman
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Toyooka |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Thoracic, Breast and Endocrine Surgery
Zip code
700-8558
Address
2-5-1 Shikata-Cho, Kita-ku, Okayama
TEL
086-235-7265
toyooka@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Yamamoto |
Organization
Okayama University Hospital
Division name
Department of Thoracic Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558 Japan
TEL
086-235-7265
Homepage URL
h.yamamoto@md.okayama-u.ac.jp
Sponsor or person
Institute
Setouchi Lung Cancer Group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/29505900
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29505900
Number of participants that the trial has enrolled
402
Results
Between November 2004 and November 2010, 402 patients from 40 institutions were included (201 in each arm). The median follow-up period was 6.5 years. The 5-year overall survival rate was 70% (95% confidential interval [CI]: 63-76] in arm A versus 73% (95% CI: 66-78) in arm B (hazard ratio = 0.92, 95% CI: 0.55-1.41, p = 0.69). There was no significant difference in the 5-year relapse-free survival rate between arms A and B (56% versus 57% [hazard ratio = 0.92, 95% CI: 0.63-1.34, p = 0.50]).
Results date posted
| 2019 | Year | 08 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with pathological stage IB to IIIA NSCLC
Participant flow
Patients were randomized into a group receiving paclitaxel (175 mg/m2) plus carboplatin (area under the curve 5) every 3 weeks for four cycles (arm A) or a group receiving orally administered UFT (250 mg/m2) daily for 2 years (arm B).
Adverse events
Toxicities were well tolerated and there was no treatment-related death. Toxicities of any grade or grade 4 were significantly more frequent in the paclitaxel plus carboplatin group (95.7% and 22.1%, respectively) than in the UFT group (76.5% and 1.0%, respectively [p < 0.0001 in both]).
Outcome measures
The primary and secondary end points were overall survival and relapse-free survival and toxicity, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2004 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2004 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2004 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 08 | Month | 27 | Day |
Last modified on
| 2019 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000968
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
