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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Suspended |
Unique ID issued by UMIN | UMIN000003782 |
Receipt No. | R000004566 |
Scientific Title | Phase I/II Trial of S-1 plus paclitaxel combination chemotherapy in elderly patients with non-small lung cancer |
Date of disclosure of the study information | 2010/06/18 |
Last modified on | 2016/12/22 |
Basic information | ||
Public title | Phase I/II Trial of S-1 plus paclitaxel combination chemotherapy in elderly patients with non-small lung cancer | |
Acronym | Phase I/II Trial of S-1 plus paclitaxel combination chemotherapy in elderly patients with non-small lung cancer | |
Scientific Title | Phase I/II Trial of S-1 plus paclitaxel combination chemotherapy in elderly patients with non-small lung cancer | |
Scientific Title:Acronym | Phase I/II Trial of S-1 plus paclitaxel combination chemotherapy in elderly patients with non-small lung cancer | |
Region |
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Condition | ||
Condition | Non-small cell lung cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To determine the maximum tolerated dose and recommended dose of S-1/PTX, and to investigate the efficacy and safety of the recommended dose for elderly patients with non-small-cell lung cancer. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Phase I
maximum tolerated dose, recommended dose Phase II response rate |
Key secondary outcomes | Phase I
toxicity, response rate Phase II toxicity, disease control rate, overall survival, relation to biomarker |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | S-1 plus Paclitaxel | |
Interventions/Control_2 | ||
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Patients with NSCLC confirmed pathologically
2)Patients who have at least one or more measurable lesion 3)Unresectable stage IIIB or IV NSCLC 4)No previous chemotherapy or radiotherapy 5)An age more than 70 years or equal 6)Performance status (ECOG) :0-1 7)Adequate organ functions 8)A life expectancy of 2 months or more 9)With ability of oral intake 10)Written informed consent |
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Key exclusion criteria | 1)Patients with serious complication
2)Patients with active double cancer 3)Patients with previous serious drug hyperseneitivity 4)receiving Flucytosine 5)Patients with alcohol allergy 6)Other conditions inadequate for this research |
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Target sample size | 45 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyoto prefectural University of Medicine | ||||||
Division name | Department of Respiratory Medicine | ||||||
Zip code | |||||||
Address | Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602, Japan | ||||||
TEL | 075-251-5513 | ||||||
yiwasaki@koto.kpu-m.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kyoto prefectural University of Medicine | ||||||
Division name | Department of Respiratory Medicine | ||||||
Zip code | |||||||
Address | Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602, Japan | ||||||
TEL | 075-251-5513 | ||||||
Homepage URL | |||||||
yiwasaki@koto.kpu-m.ac.jp |
Sponsor | |
Institute | Kyoto prefectural University of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Kyoto prefectural University of Medicine |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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 | Suspended | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004566 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |