UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005569 |
|---|---|
| Receipt number | 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 11:58:25 |
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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
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
yatsutani@msn.com
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
