UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000145 |
|---|---|
| Receipt number | 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 10:35:09 |
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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
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
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000208
