UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002182 |
|---|---|
| Receipt number | R000001991 |
| Scientific Title | A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802) |
| Date of disclosure of the study information | 2009/07/10 |
| Last modified on | 2022/09/25 17:47:32 |
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Basic information
Public title
A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)
Acronym
A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)
Scientific Title
A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)
Scientific Title:Acronym
A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)
Region
| Japan |
Condition
Condition
patients with advanced/recurrent colon cancer who cannot undergo common protocol
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A response and adverse events of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer are evaluated on patients with some disorder who cannot be registered to common protocol.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall Response Rate (ORR)
Key secondary outcomes
Incidence of Adverse Events, and their grades
Progression-Free Survival (PFS)
Overall Survival (OS)
Incidence of Completion of the regimen
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
l-LV 250 mg/m2 IV over 2 hours, followed by a slow IV dose of 5-FU 600 mg/m2 during the first hour. This is repeated three times each week and the drug is withdrawn for one week. Dosing will be repeated for one course of 4 weeks until one of the criteria for discontinuation of study treatment is met.
Bevacizumab is injected intravenously at a dose of 5 mg/kg (body weight) every 2 weeks. Dosing is repeated until one of the criteria for discontinuation of study treatment is met.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) colon cancer diagnosed pathologically
2) primary advanced colon cancer and/or metastatic colon cancer
3) with measurable lesion
4) without any prior chemotherapy or with 180 days period after
postoperative chemotherapy
5) expected more than 3 months of survival
6) patients without any severe disorder in bone marrow, lung, liver, or
kidney and satisfies the body conditions
1. Hb >= 9.0g/dL
2. WBC 4,000-12,000/mm3
3. Neutrocyte >= 1,500mm3
4. platelet >= 100,000/mm3
5. Total-bilirubin <= 1.5 mg/dL
6. AST, ALT >= 100U/L or 200U/L for patients with liver metastasis
7. sCr <= 1.2mg/dL
8. CCR >= 50mL/min
[Cockcroft-Gault]expected=[(140 - age)x body weight]/[72 x sCr]
7) with normal ECG within 28 days
8) IC form written by patient
9) patients who have at least one of these functions
1. Patients cannot be registered for l-OHP/CPT-11 therapy by a doctor
2. ECOG PS 1-2
3. age >= 65 years old
4. sAlb < 3.5 g/dl
5. prior radiation therapy for pelvic/abdominal lesions
Key exclusion criteria
1) ECOG PS 3-4
2) with a brain tumor or brain metastasis
3) with double cancer diagnosed within 5 years except for basal cell
Carcinoma, CIS of portion, and/or CIS of digestive tract treated
curatively
4) with a symptom of neuro-vascular disorder on the brain
5) without surgical treatment, open biopsy, and/or suturing of injury
6) with plans of surgical operation during this regimen
7) with easy bleeding and/or coagulation disorder
8) with a history of thrombosis
9) with an ulcer on the digestive tracts which is uncontrollable
10) with inflammation of abdominal organs
11) with a disorder of the kidney which needs some therapies
12) with an uncontrolled hypertension
13) with a severe allergy to fluorouracil. Levohorinate calcium
14)patients with a lack of enzyme; DPD (dihydropyridine dehydrogenase) or with adverse events due to fluoropyrimidine
15) with an uncontrollable diarrhea
16) with interstitial pneumonia or pulmonary fibrosis
17) patients who need immuno-suppressive medicines after an organ transplantation
18) with an uncontrollable infection
19) pregnant females, nursing mothers, or pregnancy test-positive females
20) males who do not protect against pregnancy
21) patients whose doctor cannot register for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kato |
Organization
Mino City Hospital
Division name
Dpt.Surgery
Zip code
Address
5-7-1 kasano, Minou City, Osaka 562-8562
TEL
072-728-2001
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Kato |
Organization
Mino City Hospital
Division name
Dpt.Surgery
Zip code
Address
5-7-1 kasano, Minou City, Osaka 562-8562
TEL
072-728-2001
Homepage URL
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007%2Fs10147-020-01656-3
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs10147-020-01656-3
Number of participants that the trial has enrolled
41
Results
The ORR was 36.6% [95% confidence interval (CI) 22.1-53.1%], median PFS was 9.4 months (95 CI 7.4-17.7 months), and median OS was 24.0 months (95% CI 19.9 months-not reached).
Results date posted
| 2022 | Year | 09 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 05 | Month | 26 | Day |
Baseline Characteristics
The median age was 76 years (range 56-90 years), and 51% of patients had a performance status of 0.
Participant flow
Forty-one patients were enrolled and eligible. There were no treatment-related deaths.
Adverse events
The common treatment-related adverse events of grade >= 3 were neutropenia (24%), anorexia (10%), leukopenia (7%), and mucositis/stomatitis (7%).
Outcome measures
The ORR was 36.6% [95% confidence interval (CI) 22.1-53.1%], median PFS was 9.4 months (95 CI 7.4-17.7 months), and median OS was 24.0 months (95% CI 19.9 months-not reached).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2009 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 10 | Day |
Last modified on
| 2022 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001991
