Unique ID issued by UMIN | UMIN000018428 |
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Receipt number | R000021336 |
Scientific Title | S-1 maintenance therapy after induction therapy with carboplatin and albumin-bound paclitaxel in patients with advanced squamous non-small-cell lung cancer: phase II study (HSR1502) |
Date of disclosure of the study information | 2015/07/28 |
Last modified on | 2020/07/30 10:41:44 |
S-1 maintenance therapy after induction therapy with carboplatin and albumin-bound paclitaxel in patients with advanced squamous non-small-cell lung cancer: phase II study (HSR1502)
S-1 mantenance therapy after CBDCA / nab-PTX in Sq-NSCLC.
S-1 maintenance therapy after induction therapy with carboplatin and albumin-bound paclitaxel in patients with advanced squamous non-small-cell lung cancer: phase II study (HSR1502)
S-1 mantenance therapy after CBDCA / nab-PTX in Sq-NSCLC.
Japan |
advanced squamous non-small-cell lung cancer
Pneumology |
Malignancy
NO
To assess the efficacy and safety of S-1 maintenance therapy after induction therapy with carboplatin plus albumin-bound paclitaxel (abraxane).
Safety,Efficacy
Exploratory
Phase II
PFS measured from start of the maintenance therapy
OS, PFS measured from the enrollment, response rate, disease control rate in the induction therapy, safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
induction therapy with carboplatin plus albumin-bound paclitaxel, and following S-1 maintenance therapy
20 | years-old | <= |
Not applicable |
Male and Female
1) pathologically or cytologically diagnosed as squamous NSCLC
2) clinical stage IIIB, IV or relapse
3) ECOG PS of 0-1
4) expectation of at least 3 months of survival after study therapy
5) existence of measurable lesion
6) capability of oral intake
7) adequate organ function
8) written informed consent given
1) history of pyrimidine-based chemotherapy
2) symptomatic brain metastasis (asymptomatic cases after treatments are allowed)
3) fluid retention that needs to be controlled
4) watery diarrhea
5) severe comorbidities
6) active cancers in other organs
7) existence and/or willing to pregnancy
8) psychological disorder incapable of entry for the study
70
1st name | Takafumi |
Middle name | |
Last name | Suda |
Hamamatsu University School of Medicine
Second devision, department of internal medicine
4313192
Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan
053-435-2263
karayama@hama-med.ac.jp
1st name | Masato |
Middle name | |
Last name | Karayama |
Hamamatsu Univ. School of Medicine
Department of clinical oncology
4313192
Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan
053-435-2263
karayama@hama-med.ac.jp
Hamamatsu University School of Medicine
Hamamatsu University School of Medicine
Other
Iwata general hospital, Shizuoka general hospital, Ensyu hospital, Shizuoka red-cross hospital, Shizuoka city Shizuoka hospital, Shizuoka city Shimizu hospital, Seirei Mikatahara general hospital, Seirei Hamamatsu general hospital, Tenryu hospital, Hamamatsu red-cross hospital, Hamamatsu Rosai hospital, Hamamatsu medical center, Fujieda city hospital
IRB
Handayama 1-20-1
0534352111
kennkyu@hama-med.ac.jp
NO
浜松医科大学、磐田市立総合病院、静岡県立総合病院、JA静岡厚生連遠州病院、静岡赤十字病院、静岡市立静岡病院、静岡市立清水病院、聖隷三方原病院、聖隷浜松病院、独立行政法人国立医療機構 天竜病院、浜松赤十字病院、浜松労災病院 、県西部浜松医療センター、藤枝市立総合病院
2015 | Year | 07 | Month | 28 | Day |
https://link.springer.com/article/10.1007/s10637-016-0365-4
Published
https://link.springer.com/article/10.1007/s10637-016-0365-4
51
Fifty-one patients were enrolled in the study. The median progression-free survival from the start of maintenance therapy was 3.0 months).
2020 | Year | 07 | Month | 30 | Day |
The median age was 72 years. Forty-five patients (88.2%) were male and 46 (90.2%) had a history of smoking. All patients had a histological diagnosis of squamous cell carcinoma.
Eligible patients received induction chemotherapy with intravenous carboplatin at an area under the curve (AUC) of 5 on day 1 and oral S-1 at 40 mg/m2 twice daily on days 1-14 of a 28-day cycle, for four cycles. Patients who achieved complete response, partial response, or stable disease after four cycles of induction therapy received maintenance therapy with oral S-1 at 40 mg/m2 twice daily on days 1-14 of a 21-day cycle until disease progression or unacceptable toxicity.
The major adverse events during the study are shown in Table 2. During induction therapy, the most common toxicities were anemia, thrombocytopenia, leukopenia, neutropenia and nausea. Two (3.9%), eight (15.7%), and four (7.8%) patients required granulocyte colony-stimulating factor, blood transfusion, and hospitalization, respectively. During maintenance therapy, the most common toxicities were anemia, thrombocytopenia, and fatigue, but they were not severe. Neither granulocyte colony-stimulating factor nor blood transfusion was required in the maintenance therapy group; however, one patient required hospitalization because of grade 5 bacterial pneumonia.
PFS
Completed
2015 | Year | 04 | Month | 01 | Day |
2015 | Year | 04 | Month | 01 | Day |
2015 | Year | 04 | Month | 01 | Day |
2016 | Year | 03 | Month | 31 | Day |
2015 | Year | 07 | Month | 27 | Day |
2020 | Year | 07 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021336
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