UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017894
Receipt No. R000020460
Scientific Title Phase II study of gemcitabine plus oxaliplatin combination therapy (GEMOX therapy) for the advanced pancreatic adenocarcinoma with a family history of pancreatic/breast/ovarian/prostate cancer or with a personal history of breast/ovarian/prostate cancer.
Date of disclosure of the study information 2015/06/17
Last modified on 2020/06/16 (Ver. 11)

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Basic information
Public title Phase II study of gemcitabine plus oxaliplatin combination therapy (GEMOX therapy) for the advanced pancreatic adenocarcinoma with a family history of pancreatic/breast/ovarian/prostate cancer or with a personal history of breast/ovarian/prostate cancer.
Acronym FABRIC study
Scientific Title Phase II study of gemcitabine plus oxaliplatin combination therapy (GEMOX therapy) for the advanced pancreatic adenocarcinoma with a family history of pancreatic/breast/ovarian/prostate cancer or with a personal history of breast/ovarian/prostate cancer.
Scientific Title:Acronym FABRIC study
Region
Japan

Condition
Condition Metastatic pancreatic cancer patients with a family history of pancreatic/breast/ovarian/prostate cancer or with a personal history of breast/ovarian/prostate cancer.
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of gemcitabine and oxaliplatin combination therapy in metastatic pancreatic cancer patients with with a family history of pancreatic/breast/ovarian/prostate cancer or with a personal history of breast/ovarian/prostate cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 1-year survival rate
Key secondary outcomes Overall survival, Progression-free survival, response rate, adverse events

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 Gemcitabine plus oxaliplatin combination therapy:
Gemcitabine (1,000mg/m2, div, over 100 minutes, day1), Oxaliplatin (100mg/m2, div, over 120 minutes, day1), every 2 weeks
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Diagnosed as pancreatic cancer with histologically or cytologically proven adenocarcinoma
2) Metastatic pancreatic cancer
3) Aged 20 to 79 years old
4) ECOG Performance Status of 0, 1 or 2
5) Patient who meet at least one of the following:
a) Patient who has one or more first-degree relatives with pancreatic, breast, ovarian and/or prostate cancer (Gleason score >=7).
b) Patient who has two or more close blood relatives (first- , second-, and third-degree relatives) with pancreatic, breast, ovarian and/or prostate cancer (Gleason score >=7) on same side of family.
c) Personal history of breast, ovarian and/or prostate cancer (Gleason score >=7)
6) Patients who are determined that FOLFIRINOX therapy and gemcitabine plus nab-paclitaxel therapy are not suitable by the attending physician. However on receiving a explanation of FOLFIRINOX therapy and GEM + nab-paclitaxel therapy, patients who wish to participate in the current study could be enrolled.
7) Previously untreated with systemic chemotherapy for pancreatic cancer other than neoadjuvant or adjuvant chemotherapy ended more than 6 months before
8) Meets the following criteria within 7days before enrollment
a) White blood cell count =< 12,000/mm3
b) Absolute neutrophil count >= 1,000/mm3,
c) Hemoglobin >= 9.0 g/dL
d) Platelet count >= 100,000/mm3
e) Total bilirubin =< 2.0 mg/dl; however, =< 3.0mg/dl in a subject who is treated with biliary drainage
f) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 100 IU/l; however, =< 150 IU/l in a subject who has liver metastases
g) Serum creatinine =< 1.2 mg/dl or caclculated creatinine clearance (by the Cockcroft-Gault formula) >= 60 ml/minutes.
9) Written informed consent
Key exclusion criteria 1) Synchronous or metachronous (within 3 years) malignancies except carcinoma in situ or intramucosal tumor curatively treated with local therapy
2) Known metastasis to the central nervus system
3) Presence of uncontrollable moderate or severe ascites and/or pleural effusion
4) Grade 2 or more of peripheral sensory neuropathy or peripheral motor neuropathy
5) Oral intake is impossible
6) Major surgery within 4 weeks
7) Blood transfusion or G-CSF within 2 weeks
8) Patients requiring systemic steroids medication
9) Unstable angina pectoris within 3 weeks, or with a history of myocardial infarction within 6 months
10) Interstitial pneumonia, pulmonary fibrosis
11) Severe complications such as heart failure, renal failure, liver failure, peptic ulcer with active bleeding, intestinal paralysis, uncontrolled diabetes mellitus, etc
12) Active infection requiring systemic therapy
13) Pregnant or lactating women or women of childbearing potential, Male expecting partner's pregnancy
14) Psychosis or severe mental disorder
15) History of sever allergic reaction to gemcitabine or oxaliplatin
16) Impossible to use both iodine and gadolinium due to being allergic to contrast agent
17) Inadequate physical condition, as diagnosed by attending physician
Target sample size 43

Research contact person
Name of lead principal investigator
1st name Chigusa
Middle name
Last name Morizane
Organization National Cancer Center Hospital
Division name Department of Hepatobiliary and Pancreatic Oncology
Zip code 104-0045
Address 5-1-1. Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
TEL (+81)03-3542-2511
Email cmorizan@ncc.go.jp

Public contact
Name of contact person
1st name Hideaki
Middle name
Last name Takahashi
Organization National Cancer Center Hospital East
Division name Department of Hepatobiliary and Pancreatic Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL (+81)04-7133-1111
Homepage URL
Email hidetaka@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Cancer Center Hospital Certified Review Board
Address 5-1-1, Tukiji, Chuo-ku, Tokyo
Tel 03-3542-2511
Email NCC_IRBoffice@ml.res.ncc.go.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 札幌厚生病院(北海道）
北海道大学病院（北海道）
手稲渓仁会病院（北海道）
札幌医科大学附属病院（北海道）
栃木県立がんセンター（栃木県）
自治医科大学（栃木県）
高崎総合医療センター（群馬県）
埼玉県立がんセンター（埼玉県）
東京女子医科大学八千代医療センター（千葉県）
国立がん研究センター東病院（千葉県）
杏林大学医学部付属病院（東京都）
国際医療福祉大学三田病院（東京都）
慶應義塾大学病院（東京都）
国立国際医療研究センター（東京都）
東京女子医科大学病院（東京都）
がん研究会有明病院（東京都）
帝京大学医学部附属病院（東京都）
東海大学医学部付属病院（東京都）
国立がん研究センター中央病院（東京都）
神奈川県立がんセンター（神奈川県）
聖マリアンナ医科大学病院（神奈川県）
佐久総合病院 佐久医療センター（長野県）
新潟県立がんセンター新潟病院（新潟県）
石川県立中央病院（石川県）
金沢大学附属病院（石川県）　
愛知県がんセンター中央病院（愛知県）
国立病院機構　大阪医療センター（大阪府）
大阪府立急性期・総合医療センター（大阪府）
京都府立医科大学附属病院（京都府）
京都大学医学部附属病院（京都府）
神戸大学医学部附属病院（兵庫県）
兵庫県立がんセンター（兵庫県）
神戸市立医療センター 中央市民病院（兵庫県）
鳥取大学医学部附属病院（鳥取県）
香川大学医学部附属病院（香川県）
四国がんセンター（愛媛県）
九州がんセンター（福岡県）
長崎大学病院（長崎県）
佐賀大学医学部附属病院（佐賀県）
佐賀県医療センター好生館（佐賀県）
宮崎大学医学部附属病院（宮崎県）
鹿児島大学病院（鹿児島県）
中頭病院（沖縄県）

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 17 Day

Related information
URL releasing protocol not publised
Publication of results Published

Result
URL related to results and publications https://pubmed.ncbi.nlm.nih.gov/32535711/
Number of participants that the trial has enrolled 45
Results 
Among the first 43 enrolled patients, the 1-year survival rate was 27.9% (90% CI 17.0-41.3). This trial did not meet its primary endpoint because the lower limit of the 90% CI was lower than the prespecified threshold of 30%.
Results date posted
2020 Year 06 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
There were 17 men (38%), and the median patient age was 68 years (range 28-79 years). There were two patients (4%) with a PS of two. Peritoneal metastasis and ascites were observed in 44 and 42% of patients, respectively, and 93% of patients had a family history of pancreatic, breast, ovarian, or prostate cancer in FDRs. Forty-three, 25, two, and six patients had relatives with pancreatic, breast, ovarian, and prostate cancer, respectively; these categories are not mutually exclusive. Most of the patients (84%) desired to participate in this trial despite being suitable for FOLFIRINOX or GEM plus nab-PTX.
Participant flow 
Between July 2015 and March 2017, 45 patients were enrolled. As pre-planned, 43 patients were included in the primary endpoint evaluation. All 45 patients were included in efficacy evaluations other than for the primary endpoint. One patient who did not receive any study treat-ment because of tumor progression was excluded, and the remaining 44 patients were included in the safety evaluation. The data cutoff date was October 2018.
Adverse events 
The most common grade three or four AEs were hematological toxicities. Neutropenia, leukopenia, and thrombocytopenia occurred in 36%, 27%, and 20% of patients, respectively. There was one patient (2%) who developed febrile neutropenia. The most common nonhematological grade three or four AEs were anorexia (14%), fatigue (11%), and elevated ALT (20%). There was no treatment-related death.
Outcome measures 
The primary endpoint was 1-year survival defined as the proportion of patients whose OS exceeded 365.25 days, considering leap years.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 05 Month 12 Day
Date of IRB
2015 Year 02 Month 27 Day
Anticipated trial start date
2015 Year 06 Month 19 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 13 Day
Last modified on
2020 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020460