UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026606
Receipt number R000030549
Scientific Title Phase I/II Study of Weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy in Locally Advanced Non-Small-Cell Lung Cancer. Kansai Clinical Oncology Group KCOG T-0401
Date of disclosure of the study information 2017/03/21
Last modified on 2017/03/18 17:13:31

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Basic information

Public title

Phase I/II Study of Weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy in Locally Advanced Non-Small-Cell Lung Cancer. Kansai Clinical Oncology Group KCOG T-0401

Acronym

Weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy in Locally Advanced Non-Small-Cell Lung Cancer.

Scientific Title

Phase I/II Study of Weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy in Locally Advanced Non-Small-Cell Lung Cancer. Kansai Clinical Oncology Group KCOG T-0401

Scientific Title:Acronym

Weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy in Locally Advanced Non-Small-Cell Lung Cancer.

Region

Japan


Condition

Condition

Locally Advanced Non-Small-Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

efficacy and safety of weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary end point of the phase I study was to determine a recommended dosage of paclitaxel during the concurrent chemoradiotherapy part.
The primary endpoint of the phase II study was the response rate. Secondary endpoints were progression free survival, overall survival, and safety.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The phase I study was conducted to ascertain a recommended paclitaxel dosage. In the early part, chemotherapy consisted of paclitaxel (designated dosage) on days 1, 8, 15, 29, 36, and 43, and carboplatin (AUC 5 mg/mL/min) on days 1 and 29.
RTx:60 Gy in 2-Gy fractions over 6 weeks

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

Unresectable Locally Advanced Non-Small-Cell Lung Cancer

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 age more than 20 years, less 75 years leucocytes more than 4,000/mm3, neutrocytes more than 2,000/mm3, platelets more than 100,000/mm3, haemoglobin more than 9.0 g/dL, serum creatinine less than 1.5 mg/dl, AST and ALT less than twice upper limit of normal, partial pressure of arterial oxygen greater than 70 mmHg, and no abnormality found from echocardiographic examination.

Key exclusion criteria

pulmonary fibrosis requiring oxygen therapy, myocardial infarction that occurred during the prior six months, liver cirrhosis, active haemorrhage of the digestive tract, mental disorder requiring treatment, diabetes mellitus in poor control, paresis of the intestine ileus, active infection, case with a history of radiation in the fields of radiation, allergy to polyoxyethylene component preparation, peripheral neuropathy, and pregnancy. Cases that a physician judged to be inadequate were also excluded.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Motonari Fukui

Organization

Tazuke Kofukai Medical Institute Kitano Hospital

Division name

Respiratory Disease Center

Zip code


Address

2-4-20 Ohgimachi, Kita-ku,Osaka

TEL

06-6312-1221

Email

mfukui@kitano-hp.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Motonari Fukui

Organization

Tazuke Kofukai Medical Institute Kitano Hospital

Division name

Respiratory Disease Center

Zip code


Address

2-4-20 Ohgimachi, Kita-ku,Osaka

TEL

06-6312-1221

Homepage URL


Email

mfukui@kitano-hp.or.jp


Sponsor or person

Institute

Kansai Clinical Oncology Group

Institute

Department

Personal name



Funding Source

Organization

Kansai Clinical Oncology Group

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2004 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2005 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 03 Month 18 Day

Last modified on

2017 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030549


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name