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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000097 |
Receipt No. | R000000146 |
Scientific Title | A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer |
Date of disclosure of the study information | 2005/08/31 |
Last modified on | 2015/08/31 |
Basic information | ||
Public title | A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer | |
Acronym | A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer | |
Scientific Title | A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer | |
Scientific Title:Acronym | A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer | |
Region |
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Condition | ||
Condition | ECOG PS2 patients with advanced non-small cell lung cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To compare the efficacy and safety of carboplatin and paclitaxel versus gemcitabine and vinorelbine in PS2 patients with advanced NSCLC in a randomized phase II study. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | One-year survival rate |
Key secondary outcomes | Response rate, time to progression, safety,QOL |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Carboplatin and paclitaxel | |
Interventions/Control_2 | Gemcitabine and vinorelbine | |
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 proven NSCLC with no prior chemotherapy
2. Stage IIIB with malignant pleural or pericardial effusion, stage IV, or recurrent disease after prior surgery or radiotherapy 3. Measurable or evaluable disease; 4. ECOG performance status of 2 5. Life expectancy ≥3 months 6. Age ≥18 years 7. Adequate baseline organ function: Neutrophile ≥1,500/mm3; platelet count ≥100,000/mm3; aspartate aminotransferase and alanine aminotransferase ≤5 times of the institutional upper limit; total bilirubin ≤1.5 mg/dl; serum creatinine ≤1.5 mg/dl or 24-hour creatinine clearance ≥60 ml/min 8. Signed informed consent |
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Key exclusion criteria | 1. Prior radiotherapy to evaluable disease unless subsequent progression at that site
2. Prior brain metastases if not clinically stable after surgery and/or radiotherapy 3. Uncontrolled hypertension, unstable angina pectoris, myocardial infarction <6 months before enrollment or congestive heart failure 4. Active concomitant malignancy requiring treatment. 5. Uncontrolled serious active infection 6. Pre-existing grade 2 neuropathy 7. Pregnancy or lactation |
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Target sample size | 90 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Aichi Cancer Center Aichi Hospital | ||||||
Division name | Department of Respiratory Medicine | ||||||
Zip code | |||||||
Address | 18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan. | ||||||
TEL | 0564-21-6251 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | West Japan Oncology Group | ||||||
Division name | WJOG datacenter | ||||||
Zip code | |||||||
Address | 18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan. | ||||||
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 | |
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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 | Published |
Result | |
URL related to results and publications | http://www.ncbi.nlm.nih.gov/pubmed/21293243 |
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 | |
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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 |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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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=R000000146 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |