Unique ID issued by UMIN | UMIN000002425 |
---|---|
Receipt number | R000002970 |
Scientific Title | A phase II trial of postoperative adjuvant chemotherapy with carboplatin/ docetaxel for the patients completely resected Non Small Cell Lung Cancer |
Date of disclosure of the study information | 2009/09/01 |
Last modified on | 2014/03/01 09:22:08 |
A phase II trial of postoperative adjuvant chemotherapy with carboplatin/ docetaxel for the patients completely resected Non Small Cell Lung Cancer
A phase II trial with carboplatin/ docetaxel in completely resected Non Small Cell Lung Cancer
A phase II trial of postoperative adjuvant chemotherapy with carboplatin/ docetaxel for the patients completely resected Non Small Cell Lung Cancer
A phase II trial with carboplatin/ docetaxel in completely resected Non Small Cell Lung Cancer
Japan |
non-small cell lung cancer
Chest surgery |
Malignancy
NO
feasibility
Safety
Exploratory
Pragmatic
Phase II
feasibility
safety, progression-free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
docetaxel 60mg/m2, day1 + carboplatin AUC 5mg/mLxmin, day 1
q3w, 3 cycles
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) pathologically proven non-small cell lung cancer and possible to receive chemotherapy within 4-10 weeks after surgery
2) completely resected NSCLC and pathological stage IB, II, IIIA
3) no prior chemotherapy or radiotherapy
4) PS 0 or 1
5) age 20-80
6) written informed consent
7) adequate organ function
.WBC>=4000/mm3<=12000/mm3
.neutrophil<=2000/mm3
.platelet<=100000/mm3
.AST,ALT within 2 times of upper limit
.total bilirubin <=1.5 mg/dl
.creatinin<= 1.2 mg/dl
.creatinin clearance>=60ml/min/body
PaO2>=60Torr
1) active infection
2) fever
3) severe complication
4) concomittant malignant cancer
5) Uncontroled pleural effusion or ascitis
6) Pericardial effusion
7) Neuropathy
8) past history of severe allergic reaction
9) Pregnant or expecting woman
10) other conditions not suitable for this study
65
1st name | |
Middle name | |
Last name | Takeshi Hanagiri |
University
of Occupational and Environmental Health
Second Department of Surgery
1-1 Iseigaoka, Yahatanishi-ku,
093-691-7442
hanagiri@med.uoeh-u.ac.jp
1st name | |
Middle name | |
Last name | Hidetaka Uramoto |
UOEH
Second Department of Surgery
1-1 Iseigaoka, Yahatanishi-ku,
093-691-7442
hidetaka@med.uoeh-u.ac.jp
University
of Occupational and Environmental Health
University
of Occupational and Environmental Health
NO
産業医科大学
2009 | Year | 09 | Month | 01 | Day |
Partially published
Completed
2009 | Year | 08 | Month | 31 | Day |
2009 | Year | 09 | Month | 01 | Day |
2013 | Year | 09 | Month | 01 | Day |
2013 | Year | 09 | Month | 01 | Day |
2013 | Year | 09 | Month | 01 | Day |
2014 | Year | 12 | Month | 01 | Day |
2009 | Year | 09 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002970
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |