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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | C000000234 |
Receipt No. | R000000295 |
Scientific Title | A Phase I/II Study of Carboplatin and TS-1 in Patients with Advanced Non-small Cell Lung Cancer: CJLSG-0402 |
Date of disclosure of the study information | 2005/11/24 |
Last modified on | 2013/09/21 |
Basic information | ||
Public title | A Phase I/II Study of Carboplatin and TS-1 in Patients with Advanced Non-small Cell Lung Cancer: CJLSG-0402 | |
Acronym | A phase I/II Study of CBDCA+TS-1 in Non-small Cell Lung Cancer | |
Scientific Title | A Phase I/II Study of Carboplatin and TS-1 in Patients with Advanced Non-small Cell Lung Cancer: CJLSG-0402 | |
Scientific Title:Acronym | A phase I/II Study of CBDCA+TS-1 in Non-small Cell Lung Cancer | |
Region |
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Condition | ||
Condition | Advanced non-small cell lung cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | In phase I portion, the optimal dosases of carboplatin and TS-1 will be determined. In phase II, the response rate will be measured in advanced 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: Safety, maximum tolerated doses, recommended doses
Phase II: Response rate |
Key secondary outcomes | Phase I: Response rate
Phase II: Safety, survival time |
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 | Carboplatin and TS-1 chemotherapy | |
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. Histologycally or cytologically proven non-small cell lung cancer
2. Stage IIIB with no indication of radiation therapy, and Stage IV 3. Measurable by RECIST critelia in phase II portion. 4. Age over 19 years-old, and less than 75 years-old. 5. ECOG Performance Status of 0 or 1 6. Chemo-naive 7. Post-operative or asymptomatic brain metastasis or radiation therapy to the non-target lesion is allowed. 8. Adequate bone marrow, liver, and renal functions WBC > 4,000 /uL Neutro > 2,000 /uL Platlets > 100,000 /uL Hb > 9.5 g/dL s-Cr < 1.5 mg/dL Ccr > 30 mL/min AST, ALT < 100 IU/L T.Bil < 1.5 mg/dL PzO2 > 60 mmHg or SpO2 > 90% 9. Written informed consent |
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Key exclusion criteria | 1. Massive pleural effusion with the incication of local therapy
2. Clinically appearent pericardial effusion 3. Serious medical complications: Uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure. Uncontrolled diabetes mellitus, hypertension, infections. Contraindication for carboplatin or TS-1 use 4. Pulmonary fiblosis detectable on chest X-ray films 5. Pregnant or milk-feeding female. Intention to be pregnant in the future 6. Other clinical difficulites to this study |
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Target sample size | 32 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Hospital Organization Nagoya Medical Center | ||||||
Division name | Department of Respiratory Medicine | ||||||
Zip code | |||||||
Address | 4-1-1 Sannomaru, Naka-ku, Nagoya, 460-0001 Japan | ||||||
TEL | +81-52-951-1111 | ||||||
saka@nagoya.hosp.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Hospital Organization Nagoya Medical Center | ||||||
Division name | Department of Respiratory Medicine | ||||||
Zip code | |||||||
Address | 4-1-1 Sannomaru, Naka-ku, Nagoya | ||||||
TEL | +81-52-951-111 | ||||||
Homepage URL | |||||||
saka@nagoya.hosp.go.jp |
Sponsor | |
Institute | Central Japan Lung Study Group |
Institute | |
Department |
Funding Source | |
Organization | Central Japan Lung Study Group |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization |
Other related organizations | |
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Name of secondary funder(s) |
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 | No longer recruiting | ||||||
Date of protocol fixation |
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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=R000000295 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |