Clinical Trial: Effect of High Doses of Radiation on Bone Structure and Metabolism

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pilot Study of the Effect of High Doses of Radiation on Bone Metabolism and Structure in Patients Treated With Adjuvant Radiotherapy and Surgery for Sacral Tumors

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Massachusetts General Hospital

Current Primary Outcome: Change in Bone mineral density (Tb. BMD) [ Time Frame: Non-surgical arm: baseline, 3 months Surgical arm: baseline, 9 weeks ]

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.


Original Primary Outcome: Bone mineral density (Tb. BMD) [ Time Frame: Non-surgical arm: baseline, 3 months Surgical arm: baseline, 9 weeks ]

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.


Current Secondary Outcome:

  • Physical Function [ Time Frame: Non-surgical arm: baseline, 7 weeks, ~5 months, ~8 months, ~14 months Surgical arm: baseline, ~4 months, ~6 months, ~9 months, ~15 months ]
    Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function will be used. Unit of measure will be a T-score.
  • Pain Interference [ Time Frame: Non-surgical arm: baseline, 7 weeks, ~5 months, ~8 months, ~14 months Surgical arm: baseline, ~4 months, ~6 months, ~9 months, ~15 months ]
    PROMIS Pain Interference questionnaire will be used. Unit of measure will be a T-score.
  • Anxiety [ Time Frame: Non-surgical arm: baseline, 7 weeks, ~5 months, ~8 months, ~14 months Surgical arm: baseline, ~4 months, ~6 months, ~9 months, ~15 months ]
    PROMIS Anxiety questionnaire will be used. Unit of measure will be a T-score.
  • Depression [ Time Frame: Non-surgical arm: baseline, 7 weeks, ~5 months, ~8 months, ~14 months Surgical arm: baseline, ~4 months, ~6 months, ~9 months, ~15 months ]
    PROMIS Depression questionnaire will be used. Unit of measure will be a T-score.
  • Health Related Quality of Life [ Time Frame: Non-surgical arm: baseline, 7 weeks, ~5 months, ~8 months, ~14 months Surgical arm: baseline, ~4 months, ~6 months, ~9 months, ~15 months ]
    EuroQol-5D questionnaire will be used. Unit of measurement will be an Index Value
  • Serum C-Telopeptide (CTX) [ 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 ]
    Indicator for Bone Formation, units reported in nmol CTX/mmol creatinine
  • Serum Tartrate-resistant acid phosphatase 5b (TRAP5b) [ 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 ]
    Indicator for Bone Formation, units reported in U/L
  • Serum Osteocalcin (OC) [ 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 ]
    Indicator for Bone Formation, units reported in ng/mL
  • Serum Type 1 procollagen N-terminal (P1NP) [ 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 ]
    Indicator for systemic metabolism that can affect bone health, units reported in pg/mL
  • Serum Phosphate (P) [ 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 ]
    Indicators for systemic metabolism that can affect bone health, units reported in mg/dL
  • Serum 25-hydroxycalciferol Vit D (25-OH VitD) [ 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 ]
    Indicators for systemic metabolism that can affect bone health, units reported in nmol/L
  • Bone volume fraction (BV/TV) [ Time Frame: Only in surgical arm: The week after the surgery, during witch the bone biopsies are taken (the surgeries are in week 4 and 5) ]
    Microscopic computer tomography (micro-CT) will be used and the unit of measure will be the fraction of bone volume / total volume in percentages.
  • Trabecular thickness (Tb.Th.) [ Time Frame: Only in surgical arm: The week after the surgery, during witch the bone biopsies are taken (the surgeries are in week 4 and 5) ]
    Microscopic computer tomography (micro-CT) will be used and the unit of measure will be mm.
  • Trabecular number (Tb.N.) [ Time Frame: Only in surgical arm: The week after the surgery, during witch the bone biopsies are taken (the surgeries are in week 4 and 5) ]
    Microscopic computer tomography (micro-CT) will be used and the unit of measure will be mm-1
  • Trabecular separation (Tb.Sp.) [ Time Frame: Only in surgical arm: The week after the surgery, during witch the bone biopsies are taken (the surgeries are in week 4 and 5) ]
    Microscopic computer tomography (micro-CT) will be used and the unit of measure will be mm.
  • Trabecular bone pattern factor (TBPf) [ Time Frame: Only in surgical arm: The week after the surgery, during witch the bone biopsies are taken (the surgeries are in week 4 and 5) ]
    Microscopic computer tomography (micro-CT) will be used and the unit of measure will be mm-1

  • Original Secondary Outcome: Same as current

    Information By: Massachusetts General Hospital

    Dates:
    Date Received: November 21, 2014
    Date Started: July 2015
    Date Completion: July 2019
    Last Updated: September 7, 2016
    Last Verified: September 2016