UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018428
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

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Basic information

Public 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)

Acronym

S-1 mantenance therapy after CBDCA / nab-PTX in Sq-NSCLC.

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)

Scientific Title:Acronym

S-1 mantenance therapy after CBDCA / nab-PTX in Sq-NSCLC.

Region

Japan


Condition

Condition

advanced squamous non-small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy and safety of S-1 maintenance therapy after induction therapy with carboplatin plus albumin-bound paclitaxel (abraxane).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

PFS measured from start of the maintenance therapy

Key secondary outcomes

OS, PFS measured from the enrollment, response rate, disease control rate in the induction therapy, safety


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

Medicine

Interventions/Control_1

induction therapy with carboplatin plus albumin-bound paclitaxel, and following S-1 maintenance therapy

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

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

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Takafumi
Middle name
Last name Suda

Organization

Hamamatsu University School of Medicine

Division name

Second devision, department of internal medicine

Zip code

4313192

Address

Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan

TEL

053-435-2263

Email

karayama@hama-med.ac.jp


Public contact

Name of contact person

1st name Masato
Middle name
Last name Karayama

Organization

Hamamatsu Univ. School of Medicine

Division name

Department of clinical oncology

Zip code

4313192

Address

Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan

TEL

053-435-2263

Homepage URL


Email

karayama@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hamamatsu University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

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

Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB

Address

Handayama 1-20-1

Tel

0534352111

Email

kennkyu@hama-med.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

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


Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 28 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007/s10637-016-0365-4

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s10637-016-0365-4

Number of participants that the trial has enrolled

51

Results

Fifty-one patients were enrolled in the study. The median progression-free survival from the start of maintenance therapy was 3.0 months).

Results date posted

2020 Year 07 Month 30 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

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.

Participant flow

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.

Adverse events

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.

Outcome measures

PFS

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 04 Month 01 Day

Date of IRB

2015 Year 04 Month 01 Day

Anticipated trial start date

2015 Year 04 Month 01 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 27 Day

Last modified on

2020 Year 07 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021336


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name