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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005569
Receipt No. R000005889
Scientific Title Phase II study of maintenance Bevacizumab with Pemetrexed after induction therapy of Cisplatin, Pemetrexed, and Bevacizumab in patients with advanced non-squamous non-small-cell lung cancer
Date of disclosure of the study information 2011/05/08
Last modified on 2019/07/29

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Basic information
Public title Phase II study of maintenance Bevacizumab with Pemetrexed after induction therapy of Cisplatin, Pemetrexed, and Bevacizumab in patients with advanced non-squamous non-small-cell lung cancer
Acronym MAP study
Scientific Title Phase II study of maintenance Bevacizumab with Pemetrexed after induction therapy of Cisplatin, Pemetrexed, and Bevacizumab in patients with advanced non-squamous non-small-cell lung cancer
Scientific Title:Acronym MAP study
Region
Japan

Condition
Condition Advanced or recurrent non-squamous non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigation of efficacy and safety of combination therapy of CDDP + Pemetrexed + Bevacizumab and Pemetrexed + Bevacizumab maintenance therapy for advanced non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes progression free survival
Key secondary outcomes response rate, overall survival, adverse event

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 Patients were given Cisplatin75mg/m2) + Pemetrexed(500mg/m2) + Bevacizumab(15mg/m2) on day 1, every 3 weeks, 3 to 4 cycles. Patients who get efficacy above SD, then continuously are treated with Pemetrexed(500mg/m2) + Bevacizumab(15mg/m2) on day 1, every 3 weeks, until PD.
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 1)Have non-squamous NSCLC and have not received any prior systemic chemotherapy except neoadjuvant /adjuvant therapy or EGF-TKI with Stage IIIB, not candidate for curative radiotherapy, Stage IV or recurrence disease after surgery
a) Mixed type is classified into dominant histology but mixed small cell histology is not permitted
b) Regarding the patient who have or have had pleural effusion;
*A patient who requires treatment such as drainage of the pleural space is NOT eligible
*A patient who remains without pleural effusion for more than two weeks after drainage is eligible
*A patient with history of treatment with anticancer drugs (excluding BRM such as picibanil) for pleurodesis is NOT eligible
2)Have measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, but radiation-irradiated lesion is not this case.
3)Must be 20-74 years of age at the time of consent.
4)Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0~1
5)Have adequate organ function within one week before study entry
6)Have an estimated life expectancy of at least 90days
7)Have signed an informed consent document
Key exclusion criteria 1)Have central nervous system metastases or prior therapies for brain metastasis
2)Have received radiation therapy to lesions of lung
3)Currently have or have a history of a cardiac effusion which requires treatment
4)Have another active malignancy
5)Currently have or have a history of hemoptysis, or hemosputum as defined below;
a) continue hemosputum for more than one week
b) have had or require continuous oral administration of hemostat
c) have had or require injectable administration of hemostat
6)Have possibly complication related to bleeding episode
a) Have a bleeding diathesis
b) Have a evidence of involvement in major thoracic blood vassel
c) Have a evidence of cavitation in intra-thoracic lesion
d) Have a evidence of thrombosis
7)Have anti-thrombosis drugs within 10 days before enrollment or need them during the study
8)Currently have or have a history of the below disease;
a) Currently have brain vascular disease with symptom, or have a history of it within one year before enrollment
b) Have ever had a history of gastrointestinal perforation or diverticulitis or fistula
c) Have symptomatic heart failure, unstable angina or arrhythmia which requires treatment, or have a history of cardiac infarction within one year before enrollment
d) Have any evidence of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis or pulmonary fibrosis on chest X-ray or with clinically active symptom, or have medical history of it
e) Currently have superior vena cava syndrome
f) Currently have a cord compression
g) Have a serious, nonhealing wound or unhealed bone fracture.
h) Have an uncontrollable ulcer
i) Have uncontrollable hypertension
j) Have a serious concomitant active infection, which needs antibiotics, antimycotic drugs or virucide
9)have a known sensitivity to any component of platinum drugs or monoclonal antibody drugs
10)Not have time interval described after prior therapies at the time of study entry
...etc.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Morihito
Middle name
Last name Okada
Organization Hiroshima University
Division name Surgical Oncology
Zip code 734-8551
Address Hiroshima
TEL 0822575869
Email morihito@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Tsutani
Organization Hiroshima niversity
Division name Surgical Oncology
Zip code 734-8551
Address Hiroshima
TEL 0822575869
Homepage URL
Email yatsutani@msn.com

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Hiroshima University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Committee for Clinical Research of Hiroshima University
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
Tel 082-257-5907
Email gaku-hiroshimajimu@office.hiroshima-u.ac.jp

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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 08 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000005889
Publication of results Published

Result
URL related to results and publications https://bmccancer.biomedcentral.com/articles/10.1186/s12885-018-5146-3
Number of participants that the trial has enrolled 40
Results
See the manuscript.
Results date posted
2019 Year 07 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See the manuscript.
Participant flow
See the manuscript.
Adverse events
See the manuscript.
Outcome measures
See the manuscript.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 01 Month 24 Day
Date of IRB
2011 Year 05 Month 06 Day
Anticipated trial start date
2011 Year 05 Month 06 Day
Last follow-up date
2014 Year 05 Month 06 Day
Date of closure to data entry
2014 Year 05 Month 06 Day
Date trial data considered complete
2014 Year 05 Month 06 Day
Date analysis concluded
2014 Year 06 Month 06 Day

Other
Other related information

Management information
Registered date
2011 Year 05 Month 08 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005889

Research Plan
Registered date File name
2019/07/29 MAP protocol ver 1.1..pdf

Research case data specifications
Registered date File name
2019/07/29 MAP CRF v1.1.pdf

Research case data
Registered date File name
2019/07/29 MAP study.pdf


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