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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000011897 |
Receipt No. | R000013892 |
Scientific Title | A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302) |
Date of disclosure of the study information | 2013/10/01 |
Last modified on | 2017/03/31 |
Basic information | ||
Public title | A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302) | |
Acronym | A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302) | |
Scientific Title | A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302) | |
Scientific Title:Acronym | A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302) | |
Region |
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Condition | ||
Condition | Chemo-naive patients with squamous cell lung cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the efficacy and safety of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Response rate |
Key secondary outcomes | Progression-free survival (PFS), PFS in cases given maintenance therapy, Overall survival (OS), Maintenance extraction rates, Frequency and grade of adverse event |
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 | nab-PTX 100mg/m2 (day1, 8, 15) + Carboplatin (AUC = 6, day 1) q4weeks 4cycles followed by nab-PTX 100mg/m2 (day1, 8, 15) q4weeks until disease progression | |
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.Histologically or cytologically confirmed squamous cell lung cancer
2.Stage III/IV without any indications for radiotherapy, or recurrent disease after surgery 3.chemo-naive 4.If 12 months or more pass, the adjuvant chemotherapy is not assumed to be a previous chemotherapy 5.The picibanil used by the pleurodesis is assumed to be registrable 6.EGFR, ALK, and MET inhibitor mono-therapy does not mean previous chemotherapy 7.The patients have not been conducted radiation therapy (Except for applied palliative radiation for the primary tumor) 8.Measurable disease 9.Age 20-74 10.ECOG performance status of 0 to 1 11.Adequate organ function, evaluated within 14 days before enrollment as; Neu >= 1,500 /mm3 Plt >= 100,000 /mm3 hemoglobin >= 9.0 g/dL ALT (GPT) =< 100 IU/L T. bil =< 1.5 mg/dL Cr >= 1.5mg/dL SpO2 >= 95% or >= 60 torr 12.Expected to live over 3 months after administration days 13.Written informed consent from the patients |
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Key exclusion criteria | 1.Adjuvant chemotherapy of PTX
2.Active synchronous malignancy 3.Symptomatic brain metastasis 4.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 5.>= G2 peripheral neuropathy 6.Pneumonia or Pulmonary fibrosis detectable on chest X-rays. 7.serious complication ischemic heart disease, cardiac arrhythmia, post-MI, hepatic cirrhosis, gastrointestinal ulcer, DM 8.History of severe drug allergy 9.Women with a possibility of pregnancy, pregnant or lactating 10.Patients whose participation in the trial is judged to be inappropriate by the attending doctor |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Osaka University Hospital | ||||||
Division name | Dept. of Respiratory Medicine | ||||||
Zip code | |||||||
Address | 2-15 Yamada-oka, Suita, Osaka, Japan | ||||||
TEL | 06-6879-3833 | ||||||
tkijima@imed3.med.osaka-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Osaka University Hospital | ||||||
Division name | Dept. of Respiratory Medicine | ||||||
Zip code | |||||||
Address | 2-15 Yamada-oka, Suita, Osaka | ||||||
TEL | 06-6879-3833 | ||||||
Homepage URL | |||||||
tkijima@imed3.med.osaka-u.ac.jp |
Sponsor | |
Institute | OSAKA-LCSG |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
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IRB Contact (For public release) | |
Organization | |
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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 | Terminated | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date analysis concluded |
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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=R000013892 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |