UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007004 |
|---|---|
| Receipt number | 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 | 2022/11/06 10:34:03 |
* 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 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
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
ctc004@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Gastrointestinal cancer chemotherapy Study Group(OGSG)
Institute
Department
Personal name
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
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
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9021627/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9021627/
Number of participants that the trial has enrolled
19
Results
The median 1st PFS and 2nd PFS were 12.8 months (95% confidence interval {CI] 10.4-26.7) and 19.1 months (95% CI 16.1-not reached [NR] months), respectively.
The median 1st PFS
C-group (Capecitabine + bevacizumab): 17.2 months (95% CI: 11.1 - NR)
S-group (S-1 + bevacizumab): 10.8 months (95% CI: 10.4 - NR)
F-group(LV/5-FU + bevacizumab): 11.2 months (95% CI: 7.8 - NR)
Results date posted
| 2022 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 02 | Month | 15 | Day |
Baseline Characteristics
The mCRC patients with histologically confirmed adenocarcinoma with evaluable lesions
Participant flow
From December 2, 2011, to February 18, 2015, a total of 19 patients were enrolled.
4 patients were allocated to the C-group, 10 to the S-group, and 5 to the F-group.
Adverse events
Initial Therapy
Toxicities associated with the initial therapy are neutropenia and thrombocytopenia of all grades were observed in 63% and 47%, respectively. The hematologic toxicities of grade >=3 included thrombocytopenia (5%) and neutropenia (5%). The nonhematologic toxicities of grade >=3 included anorexia (21%), proteinuria (21%), diarrhea (5%), nausea (5%), fatigue (5%), hypertension (47%), skin ulceration (5%), and thromboembolic events (5%).
Subsequent Therapy
Anemia, neutropenia, and thrombocytopenia of any grades were observed in 78, 66, and 66%, respectively. The hematologic toxicities of grade >=3 included leukopenia (11%) and neutropenia (11%). Nonhematologic toxicities of grade >=3 included anorexia (22%), hypertension (22%), febrile neutropenia (11%), and peripheral neuropathy (11%).
Outcome measures
The primary endpoint of the study was PFS between the start of enrollment and the progression of second-line treatment (2nd PFS) based on the full analysis set.
The secondary endpoints were PFS of first-line treatment, overall response rate, OS, and safety.
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
| 2022 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.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 | |
|---|---|
| Registered date | File name |
