Gastrointestinal cancer: colorectal cancer, non-colorectal cancer (gastroesophageal, pancreatic, and biliary cancer)
Conditions
Interventions
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
Sponsors
HGCSG (Hokkaido Gastrointestinal Cancer Study Group)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the efficacy of denosumab for preventing a bone mineral density reduction 16 weeks after induction of chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactMichio Nakamura
Sapporo City General Hospital Dept. of Gastroenterology
Outcome results
None listed