Unique ID issued by UMIN | UMIN000005901 |
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Receipt number | R000006978 |
Scientific Title | A phase III randomized trial of adjuvant therapy with irsogladine maleate for the patient with completely resected non-small cell lung cancer |
Date of disclosure of the study information | 2011/07/02 |
Last modified on | 2014/01/02 15:27:08 |
A phase III randomized trial of adjuvant therapy with irsogladine maleate for the patient with completely resected non-small cell lung cancer
A phase III trial of adjuvant therapy with irsogladine maleate for the resected lung cancer patient
A phase III randomized trial of adjuvant therapy with irsogladine maleate for the patient with completely resected non-small cell lung cancer
A phase III trial of adjuvant therapy with irsogladine maleate for the resected lung cancer patient
Japan |
non-small cell lung cancer
Chest surgery |
Malignancy
NO
To elucidate whether the prognoses of the resected lung cancer patients would improve or not after the administration of irsogladine maleate for 2 years
Efficacy
Confirmatory
Pragmatic
Phase III
overall survival
relapse-free survival
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
For the patient with rescted stage IA lung cancer, no adjuvant therapy is performed. For the patient with resected stage IB - IIIA, administration of tegafur-uracil for 2 years is performed.
For the patient with rescted stage IA lung cancer, administration of irsogladine maleate for 2 years is performed. For the patient with resected stage IB - IIIA, administration of tegafur-uracil and irsogladine maleate for 2 years is performed.
25 | years-old | <= |
74 | years-old | >= |
Male and Female
non-small cell lung cancer
after complete resection
after lobectomy or peumonectomy
after hilar and mediastinal dissection
pathological stage IA - IIIA
no prior treatment
ECOG performance status 0-1
sufficient organ functions
written informed consent
multiple cancer within 5 years
sever organ failure
past history of radiotherapy/chemotherapy
women with pregnancy or breast feeding
310
1st name | |
Middle name | |
Last name | Takashi Kondo |
Institute of Development, Aging and Cancer, Tohoku University
Department of Thoracic Surgery
4-1Seiryo-machi, Aoba-ku, Sendai
022-717-8521
sagawam@kanazawa-med.ac.jp
1st name | |
Middle name | |
Last name | Motoyasu Sagawa |
Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
Central study center
4-1Seiryo-machi, Aoba-ku, Sendai
022-717-8526
sagawam@kanazawa-med.ac.jp
Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
Ministry of Health, Labour and Welfare
NO
2011 | Year | 07 | Month | 02 | Day |
Published
http://www.minervamedica.it/en/journals/minerva-chirurgica/
Completed
2000 | Year | 12 | Month | 11 | Day |
2001 | Year | 05 | Month | 01 | Day |
2013 | Year | 09 | Month | 01 | Day |
2011 | Year | 07 | Month | 01 | Day |
2014 | Year | 01 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006978
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