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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
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 | 2020/09/25 |
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 |
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Condition | ||
Condition | Completely resected p-IB-IIIA non-small cell lung cancer | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
mi@thoracic.med.osaka-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |