UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005872 |
|---|---|
| Receipt number | R000006905 |
| Scientific Title | A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non-Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101) |
| Date of disclosure of the study information | 2011/06/28 |
| Last modified on | 2017/01/04 13:10:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non-Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101)
Acronym
A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101)
Scientific Title
A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non-Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101)
Scientific Title:Acronym
A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of maintenance Bevacizumab+Erlotinib following Carboplatin+Pemetrexed+Bevacizumab
with Non-squarmous Non-small-cell lung cancer not harboring EGFR mutations for
patient
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival at 6 months
Key secondary outcomes
Response rate
Shift ratio to maintenance therapy
Overall survival
Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pemetrexed+Carboplatin+Bevacizumab followed by maintenance Erlotinib+Bevacizumab until disease progression
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)Age: 20-74 years
2)Histologically or cytrologically confirmed diagnosis of non-squamous non-small cell lung cancer (non-squamous NSCLC).
3)Stage IIIB/IV or postoperative recurrence
4)No prior chemotherapy or post-operative recurrent disease without adjuvant chemotherapy or with at least one year interval from the last administration of adjuvant chemotherapy.
5)Patients who have measurable lesions.
6)Eastern Cooperative Oncology Group
(ECOG) Performance status of 0-2.
7)Adequate function of main organ.
White blood cell count>=3000/mm3
Absolute granulocyte count >= 1500/mm3
Hemoglobin >= 9.0g/dL
Platelet count >= 100,000/mm3
Serum bilirubin <= 1.5 mg/dL
AST,ALT <100 IU/l
Serum creatmine < 1.2 mg/dL or Ccr>=60ml/min
PaO2(Room air) >=60Torr (or SpO2>=95%)
Proteinuria<1+
8)Life expectancy more than 3 months
9)Written informed consent
Key exclusion criteria
1)Previous histories of drug allergy, which may increase the risk of this study.
2)Serious concomitant infection.
3)Usages of oral steroids or immunosuppressive drugs.
4)Serious complications including severe cardiovascular disease, cerebrovascular disease, severe hypertension, active peptic ulcer, uncontrolled diabetes.
5)Interstitial pneumonia or pulmonary fibrosis on chest CT scans.
6)Patients with EGFR mutation.
7)Severe pleural, abdominal or cardiac effusion.
8)Prior to study entry major surgical procedures within 3 weeks or prior systemic therapy to contain radiotherapy within 2 weeks.
9)Patient in acknowledgment of hemoptysis (2.5 ml or more) or clinically important bleeding or a clot-related event.
10)No uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 90 mmHg).
11)Symptomatic brain metastasis.
12)The patient that the tumor permeation to chest great vessels is accepted.
13)cavity in tumor.
14)receiving anticoagulant drug(except Aspirin under 325mg/day).
15)Patients with active concomitant malignancy.
16)Pregnant, lactating women.
17)Inappropriate patients judged by physicians.
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Oizumi |
Organization
Hokkaido University
Division name
First Department of Medicine
Zip code
Address
North 15,West7, Kita-ku, Sapporo 060-8638, Japan
TEL
011-706-5911
soizumi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Yamada |
Organization
Hokkaido University
Division name
First Department of Medicine
Zip code
Address
North 15,West7, Kita-ku, Sapporo060-8638, Japan
TEL
011-706-5911
Homepage URL
ymda3nr222@gmail.com
Sponsor or person
Institute
Hokkaido Lung Cancer Clinical Study Group
Institute
Department
Personal name
Funding Source
Organization
none
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
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 28 | Day |
Last modified on
| 2017 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006905
