UMIN-CTR Clinical Trial

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 Masayoshi Middle name Last name Inoue
Organization	Osaka University Graduate School of Medicine
Division name	Division of General Thoracic Surgery, Department of Surgery (E1)
Zip code	5650871
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3152
Email	mi@thoracic.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Masayoshi Middle name Last name Inoue
Organization	Osaka University Graduate School of Medicine
Division name	Department of General Thoracic Surgery
Zip code	5650871
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3152
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	Department of General Thoracic Surgery, Osaka University Graduate School of Medicine
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	Osaka University Institutional Review Board
Address	2-2 Yamadaoka Suita Osaka
Tel	06-6879-3062
Email	sirakura@orgtrp.med.osaka-u.ac.jp

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	https://pubmed.ncbi.nlm.nih.gov/28993901/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/28993901/
Number of participants that the trial has enrolled	92
Results	The chemosensitivity to carboplatin and/or paclitaxel was 76%. The 5-year OS rates were 71, 73, and 75% for all, CD-DST success, and chemosensitive patients, respectively. The 5-year DFS and OS rates of the chemosensitive patients who completed adjuvant chemotherapy using carboplatin/paclitaxel were 68 and 82%, respectively. The 5-year DFS and OS rates of the patients with stage II-IIIA chemosensitive NSCLC were 58 and 75%, respectively.
Results date posted	2020 Year 09 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	non-small-cell lung cancer
Participant flow	adjuvant chemotherapy after complete resection
Adverse events	none
Outcome measures	overall survival (OS), disease-free survival (DFS)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 05 Month 12 Day
Date of IRB	2005 Year 06 Month 07 Day
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	2020 Year 09 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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