UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014780
Receipt number R000017169
Scientific Title A randomized controlled trial of prophylactic minocycline for erlotinib-associated skin rash in non-small cell lung cancer
Date of disclosure of the study information 2014/08/08
Last modified on 2019/02/17 13:10:01

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Basic information

Public title

A randomized controlled trial of prophylactic minocycline for erlotinib-associated skin rash in non-small cell lung cancer

Acronym

A randomized controlled trial of prophylactic minocycline for erlotinib-associated skin rash in non-small cell lung cancer (PEARL-Skin)

Scientific Title

A randomized controlled trial of prophylactic minocycline for erlotinib-associated skin rash in non-small cell lung cancer

Scientific Title:Acronym

A randomized controlled trial of prophylactic minocycline for erlotinib-associated skin rash in non-small cell lung cancer (PEARL-Skin)

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology Dermatology
Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of prophylactic minocycline for erlotinib-associated skin rash in non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Frequency of grade 2 or more rash acneiform within 8 weeks

Key secondary outcomes

QoL
VAS scale for itching
safety
Time to treatment failure(TTF),
Overall survival(OS)
Objective response rate(ORR)
Disease control rate (DCR)
Frequency for dose modification or withdrawal of erlotinib


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

concomitant erlotinib and minocycline

Interventions/Control_2

erlotinib alone

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) Histologically or cytologically confirmed advanced non-small cell lung cancer
(2) Clinical stage IIIB (not amenable to curative radiation), IV or recurrent disease
(3) Intervals after any following treatment;
A) Radiation therapy
1) No history of irradiation for lung field
2) More than 12 weeks after the last irradiation for thoracic bone metastasis
3) More than 2 weeks after the last irradiation for non-thoracic region or brain metastasis region.
B) Surgical procedure
More than 1 week after the last operation (Included last pleurodesis or thoracic drainage).
C) Chemotherapy
More than 2 weeks wash-out periods after last administration of cytotoxic agent or molucular targeting agent. More than 12 weeks wash-out periods after last administration of hormone therapy.
(4) ECOG PS 0-2
(5) Patients who have at least one or more measurable lesion by RECIST (Version1.1).
(6) Life expectancy is expected more than 12 weeks .
(7) Written informed consent
(8) Adequate organ function
(9) Females must have a negative pregnancy test

Key exclusion criteria

(1) Past medical history or clinically active interstitial lung disease.
(2) Concomitant skin disease or history of treatment for skin disease within 4 weeks
(3) Patients with symptomatic brain metastasis
(4) Uncontrolled ascites, pleural effusion or cardiac effusion.
(5) Supra vena cava syndrome.
(6) Patients who needs the local therapy such as operation or irradiation for symptom relief or prevention of symptomatic disease.
(7) Past medical history of any malignant disease less than 5 years disease free period.
(8) Receiving systemic treatment of steroid or immunosuppressant within 2 weeks prior to registration. Taking topical steroid for any skin disease.
(9) No medical history of tyrosine kinase inhibitor or anti-EGFR-Abs treatment.
(10) Any unresolved toxicities from prior therapy greater than NCI-CTCAE (Ver 4.03) grade 2.
(11) Past medical history for hypersensitive for minocycline or erlotinib
(12) Contraindication for minocycline or erlotinib.
(13) Any of following gastrointestinal disorder;
1) Inability to swallow the formulated product
2) Receiving total parenteral nutrition
3) Malabsorption related past medical procedure
4) Past medical history or active inflamatory bowel disease
14) Past medical history or active severe or uncontrolled comorbidty disease.
15) Judgement by the investigator that the patient should not be participated in this trial

Target sample size

280


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiyuki Kozuki

Organization

National Hospital Organization, Shikoku Cancer Center

Division name

Thoracic oncology and Medicine

Zip code


Address

160 Kou Minamiumemoto, Matsuyama, Ehime, Japan

TEL

089-999-1111

Email

tokozuki@shikoku-cc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiyuki Kozuki

Organization

National Hospital Organization, Shikoku Cancer Center

Division name

Thoracic oncology and Medicine

Zip code


Address

160 Kou Minamiumemoto, Matsuyama, Ehime, Japan

TEL

089-999-1111

Homepage URL


Email

tokozuki@shikoku-cc.go.jp


Sponsor or person

Institute

National Hospital Organization, Thoracic Oncology Network Research Group

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

JAPAN


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

四国がんセンター (愛媛県)
旭川医療センター(北海道)
北海道がんセンター(北海道)
北海道医療センター(北海道)
水戸医療センター(茨城県)
西群馬病院(群馬県)
東京病院(東京都)
まつもと医療センター中信松本病院(長野県)
名古屋医療センター(愛知県)
長良医療センター(岐阜県)
西新潟中央病院(新潟県)
金沢医療センター(石川県)
大阪医療センター(大阪府)
近畿中央胸部疾患センター(大阪府)
刀根山病院(大阪府)
岡山医療センター(岡山県)
南岡山医療センター(岡山県)
福山医療センター(広島県)
東広島医療センター(広島県)
岩国医療センター(山口県)
山口宇部医療センター(山口県)
高知病院(高知県)
九州医療センター(福岡県)
九州がんセンター(福岡県)
福岡東医療センター(福岡県)
嬉野医療センター(佐賀県)
別府医療センター(大分県)
南九州病院(鹿児島県)
沖縄病院(沖縄県)


Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 08 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

No longer recruiting

Date of protocol fixation

2014 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 03 Month 13 Day

Last follow-up date

2018 Year 12 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

2014 Year 08 Month 06 Day

Last modified on

2019 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017169


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name