UMIN-CTR Clinical Trial

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 This is repeated three times each week and the drug is withdrawn for one week.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
Email

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
Email

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

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001991