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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000109 |
Receipt No. | R000000159 |
Scientific Title | A Phase II Study of Cisplatin, Etoposide and Concurrent Thoracic Irradiation Followed by Irinotecan and Cisplatin in Patients with Limited Small-Cell Lung Cancer |
Date of disclosure of the study information | 2005/09/02 |
Last modified on | 2015/08/31 |
Basic information | ||
Public title | A Phase II Study of
Cisplatin, Etoposide and Concurrent Thoracic Irradiation Followed by Irinotecan and Cisplatin in Patients with Limited Small-Cell Lung Cancer |
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Acronym | A Phase II Study of
Cisplatin, Etoposide and Concurrent Thoracic Irradiation Followed by Irinotecan and Cisplatin in Patients with Limited Small-Cell Lung Cancer |
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Scientific Title | A Phase II Study of
Cisplatin, Etoposide and Concurrent Thoracic Irradiation Followed by Irinotecan and Cisplatin in Patients with Limited Small-Cell Lung Cancer |
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Scientific Title:Acronym | A Phase II Study of
Cisplatin, Etoposide and Concurrent Thoracic Irradiation Followed by Irinotecan and Cisplatin in Patients with Limited Small-Cell Lung Cancer |
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Region |
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Condition | ||
Condition | LD-SCLC | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the efficacy and the toxicity of cisplatin and etoposide with concurrent twice-daily thoracic irradiation followed by a consolidation of cisplatin and irinotecan in patients with limited-stage small-cell lung cancer in a phase II study. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Two-year survival rate
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Key secondary outcomes |
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 | Cisplatin and etoposide with concurrent twice-daily thoracic irradiation followed by 3 cycles of cisplatin and irinotecan | |
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 limited-stage SCLC
2. No prior chemotherapy or radiotherapy 3. Measurable disease 4. ECOG performance status of 0-2 5. Age between 20 and 70 years 6. Life expectancy ≥ 3 months 7. Adequate organ funtion: Leukocyte count from 4,000 to 12,000/mm3; hemoglobin concentration ≥9.5 g/dl; platelet count ≥100,000/mm3; aspartate aminotransferase and alanine aminotransferase ≤2 times of the upper limit of normal value; serum bilirubin ≤1.5 mg/d; serum creatinine ≤the upper limit of normal value; 24-hour creatinine clearance ≥60 ml/min; and PaO2 ≥70 torr 8. Signed informed consent |
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Key exclusion criteria | 1. Clinically apparent interstitial pneumonitis or pulmonary fibrosis
2. Emphysema, chronic bronchitis or bronchial asthma which precludes thoracic radiotherapy 3. Malignant pleural effusion or malignant pericardial effusion 4. Active concomitant or a recent (<3 years) history of any malignancy 5. Uncontrolled hypertension, unstable angina pectoris, myocardial infarction <3 months before enrollment or congestive heart failure 6. Uncontrolled diabetes mellitus 7. Uncontrolled severe active infection 8. Intestinal paralysis or obstruction 9. Pregnancy or lactation |
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Target sample size | 60 |
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 | |||||||
Public contact | |||||||
Name of contact person |
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Organization | West Japan Oncology Group | ||||||
Division name | WJOG datacenter | ||||||
Zip code | |||||||
Address | |||||||
TEL | 06-6633-7400 | ||||||
Homepage URL | |||||||
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 | Published |
Result | |
URL related to results and publications | http://www.ncbi.nlm.nih.gov/pubmed?term=17114657 |
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 |
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Date trial data considered complete |
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Date analysis concluded |
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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=R000000159 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |