Unique ID issued by UMIN | C000000210 |
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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 |
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
Postoperative adjuvant chemotherapy according to the results of drug sensitivity test in non-small-cell lung cancer
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
Postoperative adjuvant chemotherapy according to the results of drug sensitivity test in non-small-cell lung cancer
Japan |
Completely resected p-IB-IIIA non-small cell lung cancer
Chest surgery |
Malignancy
NO
To evaluate the efficacy of collagen gel droplet embedded culture drug sensitivity test (CD-DST) in the adjuvant setting of postoperative chemotherapy.
Efficacy
Phase II
Disease free survival
Overall Survival
Toxicity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
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).
20 | years-old | <= |
75 | years-old | >= |
Male and Female
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.
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.
150
1st name | Masayoshi |
Middle name | |
Last name | Inoue |
Osaka University Graduate School of Medicine
Division of General Thoracic Surgery, Department of Surgery (E1)
5650871
2-2 Yamadaoka, Suita, Osaka
06-6879-3152
mi@thoracic.med.osaka-u.ac.jp
1st name | Masayoshi |
Middle name | |
Last name | Inoue |
Osaka University Graduate School of Medicine
Department of General Thoracic Surgery
5650871
2-2 Yamadaoka, Suita, Osaka
06-6879-3152
mi@thoracic.med.osaka-u.ac.jp
Department of General Thoracic Surgery, Osaka University Graduate School of Medicine
Department of General Thoracic Surgery, Osaka University Graduate School of Medicine
Self funding
Osaka University Institutional Review Board
2-2 Yamadaoka Suita Osaka
06-6879-3062
sirakura@orgtrp.med.osaka-u.ac.jp
NO
2005 | Year | 09 | Month | 15 | Day |
https://pubmed.ncbi.nlm.nih.gov/28993901/
Published
https://pubmed.ncbi.nlm.nih.gov/28993901/
92
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.
2020 | Year | 09 | Month | 24 | Day |
non-small-cell lung cancer
adjuvant chemotherapy after complete resection
none
overall survival (OS), disease-free survival (DFS)
Completed
2005 | Year | 05 | Month | 12 | Day |
2005 | Year | 06 | Month | 07 | Day |
2005 | Year | 07 | Month | 01 | Day |
2015 | Year | 05 | Month | 01 | Day |
2005 | Year | 09 | Month | 13 | Day |
2020 | Year | 09 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000228
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