This study is designed to characterize the effects of high energy radiation on bone breakdown, with a specific interest in reducing the rate of sacral fractures. Although radiation is very important in managing tumors, it is related to complications such as bone fractures. In this research study, the investigators are looking to determine changes in blood markers, bone density, and bone structure following radiation and to better understand the reason for these changes.
Participants in the Surgical Arm of the study will be treated according to the schedule outlined in protocol for a combined treatment with surgery and adjuvant high dose radiotherapy. Patients in the non surgical arm of the the study will be treated according to the protocol being treated with radiotherapy alone.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease)
Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)
Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Massachusetts General Hospital
Boston, Massachusetts, United States
Change in Bone Mineral Density (Tb. BMD)
Trabecular bone mineral density will be measured in mg/cm3 using volumetric Quantitative Computed Tomography (QCT) of L1, L2 and the vertebrae adjacent to the tumor.
Time frame: Non-surgical arm: baseline, 3 months Surgical arm: baseline, 9 weeks
Serum N-Telopeptide (NTX)
Indicator for Bone Formation, units reported in nmol NTX/mmol creatinine
Time frame: Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Indicator for Bone Formation, units reported in U/L
Time frame: Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months
Serum Osteocalcin (OC)
Indicator for Bone Formation, units reported in ng/mL
Time frame: Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months
Serum Type 1 Procollagen N-terminal (P1NP)
Indicator for systemic metabolism that can affect bone health, units reported in pg/mL
Time frame: Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months
Serum Phosphate (P)
Indicators for systemic metabolism that can affect bone health, units reported in mg/dL
Time frame: Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months
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Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Indicators for systemic metabolism that can affect bone health, units reported in nmol/L
Time frame: Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months
Mineral Apposition Rate (MAR)
Tetracycline quadruple labeling method will be used and the unit of measure will be um/day
Time frame: Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear.
Bone Formation Rate (BFR/BS)
Tetracycline quadruple labeling method will be used and the unit of measure will be mm3/mm2/year
Time frame: Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear.
Mineralization Lag Time (Mlt)
Tetracycline quadruple labeling method will be used and the unit of measure will be days
Time frame: Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear.
Osteoblast Number (N.Ob/BPm)
Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1
Time frame: Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).
Osteoblast Surface (Ob. S/BS)
Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1
Time frame: Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).
Osteoclast Number (N.Oc/BPm)
Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1
Time frame: Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).
Osteoclast Surface (Oc.S/BS)
Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1
Time frame: Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).