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

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 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


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

Value
https://center6.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