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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000145
Receipt No. R000000208
Scientific Title Dose-intensive weekly combination chemotherapy (cisplatin, vincristine, doxorubicin and etoposide) followed by cisplatin-etoposide therapy with concurrent thoracic irradiation: evaluation of a new treatment for limited-disease small-cell lung cancer.
Date of disclosure of the study information 2005/09/09
Last modified on 2008/05/28

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Basic information
Public title Dose-intensive weekly combination chemotherapy (cisplatin, vincristine, doxorubicin and etoposide) followed by cisplatin-etoposide therapy with concurrent thoracic irradiation: evaluation of a new treatment for limited-disease small-cell lung cancer.
Acronym Dose-intensive weekly combination chemotherapy (cisplatin, vincristine, doxorubicin and etoposide) followed by cisplatin-etoposide therapy with concurrent thoracic irradiation: evaluation of a new treatment for limited-disease small-cell lung cancer.
Scientific Title Dose-intensive weekly combination chemotherapy (cisplatin, vincristine, doxorubicin and etoposide) followed by cisplatin-etoposide therapy with concurrent thoracic irradiation: evaluation of a new treatment for limited-disease small-cell lung cancer.
Scientific Title:Acronym Dose-intensive weekly combination chemotherapy (cisplatin, vincristine, doxorubicin and etoposide) followed by cisplatin-etoposide therapy with concurrent thoracic irradiation: evaluation of a new treatment for limited-disease small-cell lung cancer.
Region
Japan

Condition
Condition limited-disease small-cell lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We planned a new regimen for the treatment of patients with LD-SCLC. First, we increased the initial dose intensity of CODE chemotherapy for 4weeks. Second, we used PE therapy with concurrent thoracic radiotherapy as a relatively early concurrent chemoradiotherapy. We conducted a multicenter pilot study to evaluate the efficacy and feasibility of this treatment regimen.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint was survival time and the secondary endpoints were the actual dose intensity, response rate, toxicity.
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
Medicine
Interventions/Control_1 The CODE treatment phase consisted of 25 mg/m2 cisplatin (i.v.) once a week for 4 weeks, 45 mg/m2 doxorubicin (i.v.) on day 1, 80 mg/m2 etoposide (i.v.) on days 1 through 3 during weeks 1 and 3, and 1 mg/m2 vincristine (i.v.) on day 1 during weeks 2 and 4.
The PE treatment phase consisted of 80 mg/m2 cisplatin (i.v.) on day 1 and 100 mg/m2 etoposide on days 1 through 3. These treatments were repeated every 4 weeks for 3 cycles.
Thoracic radiotherapy began on day 2 of the first PE cycle. Radiation was administered in twice-daily fractions separated by at least 4 hours. The total dose was 45 Gy, which administered in 30 fractions over 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
18 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria We included patients with cytologically or histologically proven small-cell lung cancer that had not undergone treatment. We defined LD as that confined to one hemithorax and any lymph nodes that could be covered by a single radiation therapy port. We included only patients with a good performance status, that is, an Eastern Cooperative Oncology Group scale value of 0 to 2. The test results as follows: white blood cell count ≥ 4,000/mm3, hemoglobin ≥ 11 g/dl, platelet count ≥ 100,000/mm3, total serum bilirubin ≤ 1.5 mg/dl, aspartate transaminase and alanine aminotransferase ≤ 100 IU/L, serum creatinine ≤ 1.2 mg/ml, 24 hour creatinine clearance ≥ 60 ml/min, and an arterial blood gas of oxygen of ≥ 70 mmHg. Disease stage was assessed by physical examination; chest radiography; computed tomography of the chest, brain, and abdomen; bone scintigraphy; bone marrow aspiration; and other tests as indicated. All patients gave informed consent for participation in this study.
Key exclusion criteria The criteria were age ≥ to 18 years and ≤ 70years, no concurrent active malignancies.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Isobe
Organization Shimane University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 89-1 Enya-cho, Izumo, Shimane 693-8501, JAPAN
TEL 0853-20-2206
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Isobe
Organization Shimane University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 89-1 Enya-cho, Izumo, Shimane 693-8501, JAPAN
TEL 0853-20-2206
Homepage URL
Email

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
Email

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
2005 Year 09 Month 09 Day

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
1996 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
1996 Year 06 Month 01 Day
Last follow-up date
2000 Year 11 Month 01 Day
Date of closure to data entry
2000 Year 11 Month 01 Day
Date trial data considered complete
2000 Year 11 Month 01 Day
Date analysis concluded
2000 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 09 Day
Last modified on
2008 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000208

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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