Unique ID issued by UMIN | UMIN000016383 |
---|---|
Receipt number | R000019029 |
Scientific Title | Phase II study of docetaxel monotherapy plus primary prophylaxis with pegfilgrastim for pre-treated locally advanced or metastatic non-small cell lung cancer. |
Date of disclosure of the study information | 2015/02/02 |
Last modified on | 2016/08/05 13:03:16 |
Phase II study of docetaxel monotherapy plus primary prophylaxis with pegfilgrastim for pre-treated locally advanced or metastatic non-small cell lung cancer.
OPH-RM-LC-1501
Phase II study of docetaxel monotherapy plus primary prophylaxis with pegfilgrastim for pre-treated locally advanced or metastatic non-small cell lung cancer.
OPH-RM-LC-1501
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
NO
Primary prophylaxis with pegfilgrastim is expected to reduce occurrence of febrile neutropenia during docetaxel monotherapy. The reduction of febrile neutropenia and severe neutropenia potentially lead to preservation of dose intensity of docetaxel and improvement of treatment efficacy. The aim of this study is to evaluate an effect of pegfilgrastim to improve treatment efficacy of docetaxel monotherapy.
Efficacy
Confirmatory
Pragmatic
Phase II
Progression-free survival
Response rate, Overall survival, Frequency of febrile neutropenia, Frequency of Grade 4 neutropenia, Adverse effects
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Addition of primary prophylaxis with pegfilgrastim to docetaxel monotherapy
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically or cytologically confirmed non-small cell lung cancer
2) Stage III / IV or recurrence after surgery, without any indications for radiotherapy or surgery
3) Evaluable disease (RECIST ver1.1)
4) Progressive disease or recurrence after platinum-containing chemotherapy
Pre-treated with EGFR-TKI in patients with active EGFR mutation.
Pre-treated with ALK inhibitor in ALK-positive patient
Adjuvant platinum-containing chemotherapy was considered as one regimen.
Interval; two week after thoracic radiotherapy
5) Age over 20 year-old
6) ECOG Performance status 0-2
7) Adequate organ function, evaluated within 14 days before enrollment
8) Expected 3 month survival
9) Written informed consent
(1) A history of docetaxel treatment
(2)Current or previous history of pulmonary fibrosis, interstitial pneumonitis or drug-induced pneumonia, revealed by chest X-ray film
(3)Concurrent thoracic radiotherapy
(4) A history of severe hypersensitivity against docetaxel or pegfilgrastim
(5)Another active advanced malignancy that requires any concurrent treatment with treatment for lung cancer
(6)Pleural effusion, ascites or peri-cardiac effusion requiring dranage.
(7)Problematic complications
(8) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
(9) Decision of ineligibility by a physician
31
1st name | |
Middle name | |
Last name | Seigo Minami |
Osaka Police Hospital
Dept. of Respiratory Medicine
10-31 Kitayama-cho, Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
06-6771-6051
seigominami@oph.gr.jp
1st name | |
Middle name | |
Last name | Seigo Minami |
Osaka Police Hospital
Dept. of Respiratory Medicine
10-31 Kitayama-cho, Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
06-6771-6051
seigominami@oph.gr.jp
Dept. Respiratory Medicine, Osaka Police Hopital
Dept. Respiratory Medicine, Osaka Police Hopital
Self funding
NO
大阪警察病院(大阪府)
2015 | Year | 02 | Month | 02 | Day |
Unpublished
Terminated
2014 | Year | 12 | Month | 24 | Day |
2015 | Year | 02 | Month | 02 | Day |
2015 | Year | 01 | Month | 30 | Day |
2016 | Year | 08 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019029
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |