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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023855
Receipt No. R000026792
Scientific Title A multicenter prospective study on the efficacy and safety of denosumab in gastrointestinal cancer patients receiving short-term periodic steroid premedication of chemotherapy-induced nausea and vomiting (ESPRESSO-02/HGCSG1602)
Date of disclosure of the study information 2016/12/01
Last modified on 2018/02/17

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Basic information
Public title A multicenter prospective study on the efficacy and safety of denosumab in gastrointestinal cancer patients receiving short-term periodic steroid premedication of chemotherapy-induced nausea and vomiting (ESPRESSO-02/HGCSG1602)
Acronym Evaluation of the steroid premedication for cancer chemotherapy associated osteoporosis (ESPRESSO-02/HGCSG1602)
Scientific Title A multicenter prospective study on the efficacy and safety of denosumab in gastrointestinal cancer patients receiving short-term periodic steroid premedication of chemotherapy-induced nausea and vomiting (ESPRESSO-02/HGCSG1602)
Scientific Title:Acronym Evaluation of the steroid premedication for cancer chemotherapy associated osteoporosis (ESPRESSO-02/HGCSG1602)
Region
Japan

Condition
Condition Gastrointestinal cancer: colorectal cancer, non-colorectal cancer (gastroesophageal, pancreatic, and biliary cancer)
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of denosumab for preventing a bone mineral density reduction in gastrointestinal cancer patients receiving the short-term periodic steroid premedication.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To investigate the efficacy of denosumab for preventing a bone mineral density reduction 16 weeks after induction of chemotherapy.
Key secondary outcomes The incidence of hypocalcemia and jawbone necrosis 16 weeks after initiation of chemotherapy.
The variation of bone turnover markers (serum BAP and NTX) 16 weeks after initiation of chemotherapy.
The serum levels of albumin, calcium(Ca), phosphorus, creatinine(Cr), alkaline phosphatase(ALP), fasting blood glucose, serum intact PTH, serum TSH, serum FT3, serum FT4, and HbA1c as well as urinary Ca and Cr measured on the indicated days: baseline, day 7, 14, 28, and 16 weeks.
Subgroup analysis for ECOG PS,Primary site, treatment schedule (weekly, biweekly, and triweekly), total amounts of steroids, and sex.
Newly bone fractures and bone metastasis
Safety
JOQOL and FRAX.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 The dose of denosumab (Prolia) is 60mg administered as a single subcutaneous injection within a week before the induction of chemotherapy. All participants should receive adequate calcium and vitamin D supplementation.
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
40 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria (1) Histologically confirmed adenocarcinoma in colorectal or non-colorectal cancers, including esophageal, gastric, pancreatic, and biliary cancer.
(2) A schedules of periodical intravenous steroid administration as premedication for prevention of chemotherapy-induced nausea and vomiting or allergic reaction that was weekly, biweekly, and triweekly, and in which >4-week steroid-free intervals were not allowed.
(3) At least 40 yo and less than 90 yo at the time of informed consent.
(4) In case with women, postmenopausal women only.
(5) Evaluable lesions, according to RECIST version 1.1 detected by CT scan or MRI.
(6) High risk patient with steroid induced secondary osteoporosis.
(7) Written informed consent to participate as a subject in this clinical study.
(8) No prior treatment for osteoporosis.
(9) The following bone marrow, liver, and kidney function parameters measured within 14 days prior to enrollment:
i) Neutrophil count: over 1500/uL
ii) Platelet count: over 75000/uL
iii) Hemoglobin: over 7.0 g/dL
iv) Total bilirubin: under 1.5 mg/dL
v) AST,ALT levels: under 100 U/L
vi) serum creatinine levels: < 1.5 mg/dL
vii) serum calcium levels: over 8.0 mg/dL
(10) ECOG PS of 0 to 1
(11) Life expectancy of at least 120 days after enrollment
(12) Already orally and/or dental care screening for eligibility has done.
Key exclusion criteria (1) Current regular use of steroids.
(2) Current regular use of bisphosphonates or other drugs that affect the skeleton.
(3) Regimens with steroid free interval >4-weeks.
(4) Patients who cannot do the examination for DXA
(5) Past radiation therapy for the evaluation lesion of DXA
(6) Past total or partial gastrectomy
(7) Serum calcium levels < 8.0 mg/dL
(8) On going dental interventional treatment.
(9) Renal dysfunction (serum creatinine levels: over 1.5 mg/dL)
(10) Other concurrent active cancer (synchronous double cancer or heterochronous double cancer with a disease-free interval of 5 years or shorter,excluding colorectal cancer, lesions consistent with intraepithelial cancer, i.e., carcinoma in situ, or intramucosal cancer that are assessed as cured by local treatment).
(11) Premenopausal, pregnant, breast-feeding, possibly pregnant women or patients wishing to have children.
(12) Accumulation of pleural, ascitic, or pericardial fluid requiring drainage
(13) Active bleeding
(14) No prior operation for gastrointestinal tract within 28 day except proctostomy.
(15) Current or past severe lung disease (e.g. interstitial pneumonia, pulmonary fibrosis, or severe emphysema).
(16) Any other active illness such as severe cardiac disease (e.g. myocardial infarction, angina pectoris, arrhythmia, or cardiac failure). Any of the following events within the 6 months prior to enrollment.
(17) Serious hypersensitivity to any ingredients of denosumab.
(18) Active infection and/or inflammatory diseases.
(19) Severe cardiac failure (over NYHA II)
(20) Ineligible for participating in this study according to the investigator.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Nakamura
Organization Sapporo City General Hospital
Division name Dept. of Gastroenterology
Zip code
Address 1-1, Kita 11 jo, Nishi 13 chome, Chuo-ku,Sapporo, Japan
TEL +81-11-726-2211
Email michio.nakamura@doc.city.sapporo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michio Nakamura
Organization Sapporo City General Hospital
Division name Dept. of Gastroenterology
Zip code
Address 1-1, Kita 11 jo, Nishi 13 chome, Chuo-ku,Sapporo, Japan
TEL +81-11-726-2211
Homepage URL
Email michio.nakamura@doc.city.sapporo.jp

Sponsor
Institute HGCSG (Hokkaido Gastrointestinal Cancer Study Group)
Institute
Department

Funding Source
Organization HGCSG (Hokkaido Gastrointestinal Cancer Study Group)
Organization
Division
Category of Funding Organization Other
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 特定非営利活動法人 北海道消化器癌化学療法研究会(HGCSG)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 31 Day
Last modified on
2018 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026792

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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