UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000210
Receipt number 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 2020/09/25 09:50:35

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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 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 or person

Institute

Department of General Thoracic Surgery, Osaka University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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