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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018882
Receipt No. R000021841
Scientific Title Phase II trial of bolus 5-FU/l-LV regimen as salvage line chemotherapy for oral fluorouracil resistant unresectable gastric cancer (HGCSG1502)
Date of disclosure of the study information 2015/09/01
Last modified on 2020/03/05

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Basic information
Public title Phase II trial of bolus 5-FU/l-LV regimen as salvage line chemotherapy for oral fluorouracil resistant unresectable gastric cancer
(HGCSG1502)
Acronym bolus 5-FU/l-LV for gastric cancer as salvage line chemotherapy (HGCSG1502 trial)
Scientific Title Phase II trial of bolus 5-FU/l-LV regimen as salvage line chemotherapy for oral fluorouracil resistant unresectable gastric cancer
(HGCSG1502)
Scientific Title:Acronym bolus 5-FU/l-LV for gastric cancer as salvage line chemotherapy (HGCSG1502 trial)
Region
Japan

Condition
Condition Gastric Cancer or Cancer at the Esophagogastric Junction
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the efficacy and safety of weekly bolus 5-FU and l-LV regimen for the standard treatment refractory or intolerance of unresectable advanced or recurrent gastric cancer or cancer at the esophagogastric junction
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival rate at the time the treatment after 8 weeks
Key secondary outcomes response rate, disease control rate, overall survival, progression free survival, time to treatment failure, adverse events, dose intensity and QOL by EORTC QLQ-C30

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients are administrated bolus 5-FU/l-LV regimen chemotherapy consists of l-LV 250mg/m2/2h iv and 5-FU 600mg/m2 iv bolus given intravenously once weekly followed by 2-week rest period, within a 8-week cycle. It will continue as long as it does not correspond to the discontinuance criteria.
Discontinuance criteria as follows,
a. When the patient makes an offer and consent of the withdrawal of the decline of participation research from research subjects.
b. When the treatment due to adverse events directly attributable to the investigating treatment can not be resumed be postponed exceeding 28 days
c. When 2-step dose-down when it takes a rest beyond applicable for 14 days washout standards to be administered (5-FU 360mg / m2)
d. When the disease progression has been confirmed by diagnostic imaging, etc.
e. When the patient need the radiation therapy and has started.
f. When the entire present study has been discontinued.
g. When the investigator has determined that the appropriate discontinuation of this study.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. it was confirmed that it is histologically adenocarcinoma, unresectable gastric cancer or recurrent gastric cancer cases (not required histological confirmation in metastases)
2. Age: 20 years of age or older.
Patient 3.ECOG PS of (Eastern Cooperative Oncology Group, Performance status) 0, 1 or 2,
4. S-1 or refractory to capecitabine against gastric cancer. However, after radical resection was enforced, if the S-1 or capecitabine was administered as adjuvant chemotherapy, it is determined that the refractory as long as it is a relapse within six months.
5. refractory or intorelance to chemotherapy, including platinum formulation (cisplatin or oxaliplatin).
6. refractory or intorelance to chemotherapy, including taxanes (paclitaxel or docetaxel).
7. refractory or intorelance to chemotherapy, including irinotecan.
8. refractory or intorelance to chemotherapy, including Ramucirumab.
9. Patients who wish to be given aggressive chemotherapy
patient
10. major organs (bone marrow, heart, lung, kidney, etc.) feature of being held
a. Neutrophil count is 1,200 / mm3 or more
b. Platelet count is 75,000 / mm3 or more
c. ALT is 3 times or less of the facility reference value upper limit. However five times or less the case with a liver metastasis.
d. T-Bil is less than 2.0mg / dl
e. Serum Cre is less than 2.0mg / dl
11. Patients can be expected to survive more than two months at the time
12. confirmed written informed consent
Key exclusion criteria 1. patients with symptomatic central nerve metastasis
2. patients with uncontrolled active infection
3. patients with uncontrollable diarrhea
4. patients with uncontrollable ischemic heart disease
5. patients with ascites that requires frequent drainage
6. patients with intestinal obstruction condition requiring sustained drainage by long tube
7. patients with other serious complications not to be able to be given anti-cancer chemotherapy
8. Patients with other overlapping malignancies that can be a prognostic factor.
9. patients with difficulty to their decision-making with severe mental disorders to be estimated.
10. pregnant, or female patients with intention of lactating and pregnancy and childbirth.
11. Male patients who are willing to let the pregnancy.
12. patients using flucytosine.
13. Patients who have undergone bolus 5-FU containing anti-cancer chemotherapy in the past for their gastric cancer.
14.S-1 and capecitabine last administration day within seven days.
15. patient during radiation therapy.
16. Other, patients attending physician has determined unsuitable for the target of the study treatment.
Target sample size 38

Research contact person
Name of lead principal investigator
1st name Yoshito
Middle name
Last name Komatsu
Organization Hokkaido University Hospital
Division name cancer center
Zip code 060-8648
Address Kita-15, Nishi-5, Kita-Ku, Sapporo City, Hokkaido, Japan
TEL +81-11-706-5657
Email ykomatsu@ac.cyberhome.ne.jp

Public contact
Name of contact person
1st name Tetsuhito
Middle name
Last name Muranaka
Organization Hokkaido University Hospital
Division name cancer center
Zip code 060-8648
Address Kita-15, Nishi-5, Kita-Ku, Sapporo City, Hokkaido, Japan
TEL +81-11-706-5657
Homepage URL
Email tmuranaka@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital Cancer Center
Institute
Department

Funding Source
Organization Hokkaido Gastrointestinal Cancer Study Group
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization 13) Clinical Research and Medical Innovation Center, Hokkaido University Hospital
Address Kita-15, Nishi-5, Kita-Ku, Sapporo City, Hokkaido, Japan
Tel 011-706-7636
Email crjimu@huhp.hokudai.ac.jp

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
2015 Year 09 Month 01 Day

Related information
URL releasing protocol https://www.longdom.org/abstract/feasibility-study-of-bolus-5fluorouracillleucovorin-as-salvage-line
Publication of results Partially published

Result
URL related to results and publications https://oncologypro.esmo.org/meeting-resources/esmo-asia-congress-2019/multi-centered-phase-ii-trial
Number of participants that the trial has enrolled 29
Results
Among the 29 enrolled patients, PFS rate at 8 weeks was 55.2% (95% CI 35.6% to 71.0%), which was higher than 47.5% which is the expected value of the hypothesis, and the lower limit of 95% CI is significantly higher than the threshold which is 23.1%. Grade 3 to 4 hematological adverse events (AE) were as follows; anemia 20.7%, neutropenia 3.4%, and platelet count decreased 3.4%. Grade 3 to 4 non-hematological AE were observed as follows; anorexia 20.7%, fatigue 13.8%, and diarrhea 3.4%. 
Results date posted
2019 Year 09 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Inclusion Criteria
The study subjects are patients with a diagnosis of unresectable advanced, metastatic, or recurrent gastric cancer, which have had resistance of S-1 or capecitabine, and had resistance or intolerance of cisplatin or oxalilatin, paclitaxel or docetaxel, irinotecan, and ramucirumab.
Participant flow
Participants participate in the eligible cases at the research participating facility after the researcher gives a written explanation and obtains consent by signature.
Adverse events
Grade 3 to 4 hematological adverse events (AE) were as follows; anemia 20.7%, neutropenia 3.4%, and platelet count decreased 3.4%. Grade 3 to 4 non-hematological AE were observed as follows; anorexia 20.7%, fatigue 13.8%, and diarrhea 3.4%. 
Outcome measures
Among the 29 enrolled patients, PFS rate at 8 weeks was 55.2% (95% CI 35.6% to 71.0%), which was higher than 47.5% which is the expected value of the hypothesis, and the lower limit of 95% CI is significantly higher than the threshold which is 23.1%.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 10 Month 22 Day
Date of IRB
2015 Year 10 Month 19 Day
Anticipated trial start date
2015 Year 11 Month 13 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
2018 Year 11 Month 30 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 09 Month 01 Day
Last modified on
2020 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021841

Research Plan
Registered date File name
2019/09/15 〔No.015-0230〕HGCSG1502プロトコールv1.6【170322承認】.docx

Research case data specifications
Registered date File name
2019/09/15 RPMIデータ_20181213.zip

Research case data
Registered date File name
2019/09/15 RPMIデータ_20181213.zip


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