UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial of prophylactic minocycline for erlotinib-associated skin rash in non-small cell lung cancer
Title of the study (Brief title)	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	Toshiyuki Kozuki
Organization	National Hospital Organization, Shikoku Cancer Center
Division name	Thoracic oncology and Medicine
Address	160 Kou Minamiumemoto, Matsuyama, Ehime, Japan
TEL	089-999-1111
Email	tokozuki@shikoku-cc.go.jp

Public contact
Name of contact person	Toshiyuki Kozuki
Organization	National Hospital Organization, Shikoku Cancer Center
Division name	Thoracic oncology and Medicine
Address	160 Kou Minamiumemoto, Matsuyama, Ehime, Japan
TEL	089-999-1111
Homepage URL
Email	tokozuki@shikoku-cc.go.jp

Sponsor
Institute	National Hospital Organization, Thoracic Oncology Network Research Group
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017169