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
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
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
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
