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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000219 |
Receipt No. | R000000285 |
Scientific Title | A combination phase II study of paclitaxel and gemcitabine for recurrent or relapsed non-small cell lung cancer previously treated with platinum or docetaxel-based regimen |
Date of disclosure of the study information | 2005/09/13 |
Last modified on | 2018/09/19 |
Basic information | ||
Public title | A combination phase II study of paclitaxel and gemcitabine for recurrent or relapsed non-small cell lung cancer previously treated with platinum or docetaxel-based regimen | |
Acronym | Phase II study of paclitaxel and gemcitabine for previously treated non-small cell lung cancer | |
Scientific Title | A combination phase II study of paclitaxel and gemcitabine for recurrent or relapsed non-small cell lung cancer previously treated with platinum or docetaxel-based regimen | |
Scientific Title:Acronym | Phase II study of paclitaxel and gemcitabine for previously treated non-small cell 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 evaluate the efficacy and safety of paclitaxel and gemcitabine for non-small cell lung cancer previously treated with platinum or docetaxel |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Response rate
(according to RECIST criteria) |
Key secondary outcomes | Adverse events,
Survival rate, Survival time, Time to progression, Completion of the treatment |
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 | The chemotherapy consisted of paclitaxel 150 mg/m2, iv, on day 1 ,and gemcitabine 1000 mg/m2, iv, on days 1 and 8. The treatment was repeated every 3 weeks. | |
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 non-small cell lung cancer.
2) Stage IV or IIIB unsuitable for thoracic radiation. 3) Measurable lesions. Measurable lesions should exist outside of the radiation field. 4) Non-small cell lung cancer with previous chemotherapy containing platinum or docetaxel. One or two previous regimens are allowed. 5) Age<75 6) ECOG PS 0-1 7) Adequate organ function WBC>4000/mm2; Hg>10.0g/dl; Platelet count>100,000/mm2; Total bilirubin<1.5mg/dl; AST & ALT <2x upper normal limit; Serum-creatinine 8) Life expectancy of more than 3months. 9) No complication of serious heart and pulmonary diseases. 10) No active double cancer within 3 year. 11) Written informed consent. |
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Key exclusion criteria | 1) Patients with lesions that can not judged for response by only chemotherapy. Patients previously treated with chemoradiotherapy are not allowed to be enrolled.
2) Active infectious disease and complications that affect the trial. 3) Apparent interstitial pneumonitis or fibrosis on chest X ray. 4) Symptomatic brain metastases. 5) Patients requiring pleural/ pericardial drainage. 6) Previous chemotherapy with gemcitabine or paclitaxel. 7) Allergy for a polyoxyethylene castor oil or a hardening castor oil component drug. 8) Woman who has a possibility of pregnancy. 9) Interval less than 30days from the last day of a previous treatment. 10) Other patients unsuitable for the study. |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kobe City General Hospital | ||||||
Division name | Division of Respiratory Medicine | ||||||
Zip code | |||||||
Address | 4-6 Minatomajima-nakamachi Chuo-ku Kobe 650-0046, Japan | ||||||
TEL | 078-302-4321 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Kobe City General Hospital | ||||||
Division name | Division of Respiratory Medicine | ||||||
Zip code | |||||||
Address | 4-6 Minatomajima-nakamachi Chuo-ku Kobe 650-0046, Japan | ||||||
TEL | 078-302-4321 | ||||||
Homepage URL | |||||||
t-nishi@kcgh.gr.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 |
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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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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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=R000000285 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |