![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | C000000116 |
Receipt No. | R000000172 |
Scientific Title | randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for stage IB-IIIA non small cell lung cancer after complete resection |
Date of disclosure of the study information | 2005/09/06 |
Last modified on | 2019/01/29 |
Basic information | ||
Public title | randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for
stage IB-IIIA non small cell lung cancer after complete resection |
|
Acronym | randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for
stage IB-IIIA non small cell lung cancer after complete resection |
|
Scientific Title | randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for
stage IB-IIIA non small cell lung cancer after complete resection |
|
Scientific Title:Acronym | randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for
stage IB-IIIA non small cell lung cancer after complete resection |
|
Region |
|
Condition | ||
Condition | stage IB-IIIA non small cell lung cancer after complete resection | |
Classification by specialty |
|
|
Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To estimate the efficacy of Gemcitabine monotherapy 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 | overall 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 | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | experimental arm: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6
cycle |
|
Interventions/Control_2 | standard arm: UFT 250mg/m2, daily for 1 year | |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1.completely resected non small cell lung cancer
2.no prior anti cancer treatment for thoracic malignancy exept for this operation 3.pathological stage IB, II, and stage IIIA with only one station of n2 disease 4.PS 0-1 5.age 20-75 6.adequate oragan function for chemotherapy 7.written informed consent |
|||
Key exclusion criteria | 1.small cell lung cancer or low grade malignancy of lung cancer
2.incomplete resection 3.apparant interstitial pneumonitis at chest rentogenogram 4.inadequate conditon for chemotherapy |
|||
Target sample size | 600 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Osaka City General Hospital | ||||||
Division name | Division of Thoracic Surgery | ||||||
Zip code | |||||||
Address | Miyakojima Hondhori 2-13-22 | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
|
||||||
Organization | West Japan Oncology Group | ||||||
Division name | WJOG datacenter | ||||||
Zip code | |||||||
Address | |||||||
TEL | 06-6633-7400 | ||||||
Homepage URL | |||||||
datacenter@wjog.jp |
Sponsor | |
Institute | West Japan Oncology Group |
Institute | |
Department |
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 | |
Address | |
Tel | |
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 |
|
Related information | |
URL releasing protocol | |
Publication of results | Partially published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Main results already published | ||||||
Date of protocol fixation |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000172 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |