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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007004
Receipt No. R000008190
Scientific Title A phase II study to confirm the effectiveness of a sequence therapy consisted induction therapy (Capecitabin or S-1 or sLV/5-FU plus Bevacizumab) and following therapy (induction therapy + oxaliplatin) for unresectable advanced/recurrent colo-rectal cancer (OGSG 1107)
Date of disclosure of the study information 2012/01/04
Last modified on 2020/01/05

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Basic information
Public title A phase II study to confirm the effectiveness of a sequence therapy consisted induction therapy (Capecitabin or S-1 or sLV/5-FU plus Bevacizumab) and following therapy (induction therapy + oxaliplatin) for unresectable advanced/recurrent colo-rectal cancer (OGSG 1107)
Acronym A phase II study to confirm the effectiveness of a sequence therapy consisted induction therapy (Capecitabin or S-1 or sLV/5-FU plus Bevacizumab) and following therapy (induction therapy+oxaliplatin) for unresectable advanced/recurrent colo-rectal cancer
Scientific Title A phase II study to confirm the effectiveness of a sequence therapy consisted induction therapy (Capecitabin or S-1 or sLV/5-FU plus Bevacizumab) and following therapy (induction therapy + oxaliplatin) for unresectable advanced/recurrent colo-rectal cancer (OGSG 1107)
Scientific Title:Acronym A phase II study to confirm the effectiveness of a sequence therapy consisted induction therapy (Capecitabin or S-1 or sLV/5-FU plus Bevacizumab) and following therapy (induction therapy+oxaliplatin) for unresectable advanced/recurrent colo-rectal cancer
Region
Japan

Condition
Condition Colo-rectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to know the feasibility and effectiveness of a sequence therapy consisted by the induction therapy (5-FU or Capecitabin or S-1 plus Bevacizumab) and the following therapy (induction therapy plus Oxaliplatin) for unresectable advanced/recurrent colo-rectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression Free Survival between the start of treatment and Progression of second line treatment (1st +2nd PFS)
Key secondary outcomes Progression Free Survival of 1st line treatment
Response Rate
Disease Control Rate
Overall Survival
Adverse Events (Incidence and Grades)
Medicines with good response during overall treatment by KRAS status

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Capecitabin is administered between day 1 and 14 orally followed by 7 days rest. Bevacizumab is administered 7.5mg/kg by intra-venous infusion on day 1. One course takes 3 weeks.
After 1st-PD, 130mg/m2 of oxaliplatin is added by intra-venous infusion on day 1 of this three week regimen.
Interventions/Control_2 S-1 is administered between day 1 and 14 orally followed by 7 days rest.
Bevacizumab is administered 7.5mg/kg by intra-venous infusion on day 1.
One course takes 3 weeks.
After 1st-PD, 130mg/m2 of oxaliplatin is added by intra-venous infusion on day 1 of this three week regimen.
Interventions/Control_3 A continuous 5-FU administration (2400mg/m2 by 46 hours) is done after LV (200mg/m2) and following bolus 5-FU (400mg/m2) are administered intra-venously.
Bevacizumab is administered 5mg/kg by intra-venous infusion on day 1. One course takes 2 weeks.
After 1st-PD, 85mg/m2 of oxaliplatin is added by intra-venous infusion on day 1 of this two week regimen. Bevacizumab is administered 5mg/kg by intra-venous infusion on day 1 of this two week regimen.
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)Histologically proven colon cancer or rectal cancer
2)with lesions which can be estimated by RECIST criteria version 1.1
3)with unresectable factors
4)without any symptoms which influence to lives
5)age between 20 and 75 years old
6)PS : 0-2
7)without any prior chemotherapy except fluoro-pyrimidine over 6 months ago
8)with enough rest period after prior modality :
a)More than 4 weeks of surgical treatment
b)More than 4 weeks of hormone therapy or immunotherapy
c)More than 4 weeks of cytokine or BMR
9)with good function of important organs
a)WBC : 3,000/mm3 <= and <= 10,000/mm3
b)neutrophil : 1,500/mm3 <=
c)Hemoglobin : 9.0g/dL <=
d)Platelet : 100,000/mm3 <=
e)AST/ALT : within 3 times of normal range of the hospital
f)Total bilirubin : 1.2mg/dL >=
g)s-Creatinine : 1.2mg/dL >=
h)ALP : 300U/L >=
i)Creatinine clearance >= 50mL/min
male : [(140-age) x B.W.(kg)]/[(72 x s-crearinine(mg/dL)]
female : [(140-age) x B.W.(kg) x 0.85]/[(72 x s-crearinine(mg/dL)]
10)patients expected more than 8 weeks survival
11)with written informed consent
Key exclusion criteria 1)with symptoms due to brain metastasis
2)with uncontrollable diarrhea
3)with difficulty on oral intake due to intestinal paralysis or obstruction
4)with infectious disease or febrile condition
5)HBs Ag (+)
6)with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.)
7)with severe diseases (uncontrollable DM, heart failure severe than NYHA III, renal failure and/or hepatic failure)
8)pregnant and/or nursing women, or women who expect pregnancy
9)with metastatic meningitis, uncontrollable convulsion, and/or mental disorder
10)with a more than grade 1 neural disorder
11)with a condition intolerant to medicines in this regimen (5-FU, Xeloda, TS-1, Avastine or Erplat)
12)with a history of allergy against 5-Fu, Capecitabine or TS-1
13)with a history of some chemotherapy and/or therapy including a VEGF antagonist for unresectable advanced/recurrent colon cancer
14)with a history of embolism, brain infarction (except Lacuna infarction) or pulmonary infarction
15)under easy bleeding condition due to some diseases or medicines (except low dose aspirin)
16)with a history of thoracic surgery or abdominal surgery 28 days ago except reservoir surgery
17)with active wounds
18)with a history of bloody spit more than 2.5mL
19)any other patient whom the physician in charge of the study judges to be unsuitable
Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Goto
Organization Osaka Medical College Hospital
Division name Chemotherapy Center
Zip code
Address 2-7, Daigakucho, takatsuki, Osaka
TEL 072-683-1221
Email in2030@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoki Yoshida
Organization Chemotherapy Center
Division name Department of surgery
Zip code
Address 2-7, Daigakucho, takatsuki, Osaka
TEL 072-366-0221
Homepage URL
Email ctc004@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Gastrointestinal cancer chemotherapy Study Group(OGSG)
Institute
Department

Funding Source
Organization Osaka Clinical Study Supporting Organization
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
Email

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 大阪医科大学(大阪府)、大阪医療センター(大阪府)、市立貝塚病院(大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 04 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 Completed
Date of protocol fixation
2011 Year 10 Month 31 Day
Date of IRB
2011 Year 07 Month 04 Day
Anticipated trial start date
2011 Year 12 Month 02 Day
Last follow-up date
2017 Year 02 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 05 Month 29 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 03 Day
Last modified on
2020 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008190

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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