UMIN-CTR Clinical Trial

Public title

A phase I/II study of chemoradiation with use of carboplatin/nab-paclitaxel and concurrent radiotherapy for local advanced non-small cell lung cancer

Acronym

A phase I/II study of chemoradiation with use of carboplatin/nab-paclitaxel and concurrent radiotherapy for local advanced non-small cell lung cancer

Scientific Title

A phase I/II study of chemoradiation with use of carboplatin/nab-paclitaxel and concurrent radiotherapy for local advanced non-small cell lung cancer

Scientific Title:Acronym

A phase I/II study of chemoradiation with use of carboplatin/nab-paclitaxel and concurrent radiotherapy for local advanced non-small cell lung cancer

Region

Japan

Condition

Locally Advanced Non-Small Cell Lung Cancer

Classification by specialty

Pneumology	Hematology and clinical oncology	Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine the recommened doses and assess the efficacy and safety of Carboplatin plus nab-paclitaxel with concurrent Thoracic radiotherapy for locally advanced non-small cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

phase I:determine the recommended dose
phase II:2year survival rate

Key secondary outcomes

phase I:safety, response rate, progression free survival,overall survival, completion rate of chemoradiotherapy
phase II:safety, response rate, progression free survival, overall survival, completion rate of chemoradiotherapy

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Chemoradiotherapy:
Combination of weekly carboplatin plus nab-paclitaxel with concurrent thoracic radiotherapy for a total 60Gy at 2Gy/fraction/day 5times weekly for 30 times.

Consolidation therapy:
Combination of carboplatin plus nab-paclitaxel every 3 weeks for 2 cycles.

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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Cytologically or histologically documented NSCLC.
2)Untreated Stage IIIA or IIIB disease
3)Unresectable
4)V20 under 35 percent and an approval of a radiotherapist by CT simulation based on the restriction of this protcol before registration.
5)Have measurable lesion
6)Patient aged 20-74 years old at the time of consent.
7)Eastern Cooperative Oncology Group Performance Status(ECOG PS) 0 or 1
8)Organ functions are met for this study within two week before study entry.
9)With signed an informed consent document

Key exclusion criteria

1) With opposite hilar lymph nodes metastases
2) With interstitial lung disease, lung fibrosis
3) SVC syndrome
4) With active infection
5) With active double cancer
6) With other serious disease condition (bleeding, cardiac diseases, poorly controlled diabetes,etc.)
7) Clinically significant allergy
8) Patients with steroid treatment
9) Uncontrolled psychiatric disease
10) Pregnancy or lactating patients
11) Positive serum HBs antigen
12) Others

Target sample size

56

Name of lead principal investigator

1st name
Middle name
Last name	Isamu Okamoto

Organization

kyushu University Hospital

Division name

Center for Clinical and Translational Research

Zip code

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka City

TEL

0926425378

Email

okamotoi@kokyu.med.kyushu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yuko Kawano

Organization

Kyushu Univiersity Hospital

Division name

Respiratory Medicine

Zip code

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka City

TEL

0926425378

Homepage URL

Email

yukokawa@kokyu.med.kyushu-u.ac.jp

Institute

Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University

Institute

Department

Personal name

Organization

Taiho Pharmamedical Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

12

Month

27

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2013

Year

12

Month

27

Day

Date of IRB

Anticipated trial start date

2013

Year

12

Month

27

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

12

Month

27

Day

Last modified on

2019

Year

01

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014671