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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000210
Receipt No. R000000228
Scientific Title Clinical trial of postoperative adjuvant chemotherapy with carboplatin/paclitaxel according to the results of collagen gel droplet embedded culture drug sensitivity test (CD-DST) in completely resected non-small-cell lung cancer
Date of disclosure of the study information 2005/09/15
Last modified on 2012/10/25

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Basic information
Public title Clinical trial of postoperative adjuvant chemotherapy with carboplatin/paclitaxel according to the results of collagen gel droplet embedded culture drug sensitivity test (CD-DST) in completely resected non-small-cell lung cancer
Acronym Postoperative adjuvant chemotherapy according to the results of drug sensitivity test in non-small-cell lung cancer
Scientific Title Clinical trial of postoperative adjuvant chemotherapy with carboplatin/paclitaxel according to the results of collagen gel droplet embedded culture drug sensitivity test (CD-DST) in completely resected non-small-cell lung cancer
Scientific Title:Acronym Postoperative adjuvant chemotherapy according to the results of drug sensitivity test in non-small-cell lung cancer
Region
Japan

Condition
Condition Completely resected p-IB-IIIA non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of collagen gel droplet embedded culture drug sensitivity test (CD-DST) in the adjuvant setting of postoperative chemotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Disease free survival
Key secondary outcomes Overall Survival
Toxicity

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Adjuvant chemotherapy with carboplatin (6AUC) + paclitaxel (70mg/m2 x 3 week) x 4 courses is given to p-stage IB-IIIA non-small cell lung cancer patients whose tumors show moderate or high sensitivity to these drugs in collagen gel droplet embedded culture drug sensitivity test (CD-DST).
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1, Pathologically proven non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, large cell carcinoma).
2, p-stage IB-IIIA.
3, No previous chemotherapy.
4, ECOG Performance Status (PS) 0 - 1.
5, Adequate major organ function.
6, No active other malignancy.
7, Written informed consent.
Key exclusion criteria 1, Heart diseases required treatment.
2, Myocardial infarction within 6 months.
3, Liver cirrhosis.
4, Symptomatic interstitial pneumonia or pulmonary fibrosis proven in the chest X-ray.
5, Active bowel hemorrhage required repeated transfusion.
6, Uncontrollable diabetes mellitus.
7, Ileus or subileus.
8, Active infection.
9, Peripheral neuropathy.
10, Psychological disorder required medication.
11, Drug allergy against cremophor EL(polyoxethylated castor oil).
12, During pregnancy or lactation.
13, Inadequate condition diagnosed by the primary physician.

Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayoshi Inoue
Organization Osaka University Graduate School of Medicine
Division name Division of General Thoracic Surgery, Department of Surgery (E1)
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3152
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of Medicine
Division name Department of General Thoracic Surgery
Zip code
Address
TEL
Homepage URL
Email mi@thoracic.med.osaka-u.ac.jp

Sponsor
Institute Department of General Thoracic Surgery, Osaka University Graduate School of Medicine
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 15 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 No longer recruiting
Date of protocol fixation
2005 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2005 Year 07 Month 01 Day
Last follow-up date
2015 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 13 Day
Last modified on
2012 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000228

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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