Malignant Bone TumorsNCT02323295
Effect of High Doses of Radiation on Bone Structure and Metabolism
A study testing Radiation (Surgical Arm), Radiation (Non-surgical Arm) and Malignant Tumor Surgery in people with Malignant Bone Tumors, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Bone Tumors
- What is being tested?
- Radiation (Surgical Arm), Radiation (Non-surgical Arm) and Malignant Tumor Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All laboratory tests that are a part of the eligibility criteria must be completed within 14 days prior to the date of registration. Diagnostic tests that are a part of the eligibility criteria must be performed within 30 days of the date of registration. Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Study participants must have histologically confirmed primary malignant bone tumor in the sacrum for which surgery and radiation or radiation alone are planned.
- Age 18 years or older. In children under the age of 8, tetracycline derivatives have been reported to stain tooth enamel yellow color. These considerations lead us to exclude young persons under the age of 18 from the study.
- Participants must have normal organ and marrow function as defined below:
- Total bilirubin within normal institutional limits
- Aspartaataminotransferase (AST) (SGOT)/ Alanine-aminotransferase (ALT) (SGPT) < 2.5 X institutional upper limit of normal
Show all 9Show fewer
- Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal limit
- The effects of tetracyclines and radiation used in computer tomography on the developing human fetus are known to be detrimental. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Participants must be able to read and understand English language and have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Participants who have had surgery, chemotherapy, or radiotherapy of the sacrum prior to entering the study
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to tetracyclines.
- Pregnant or nursing
- Uncontrolled inter current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
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.
Read the detailed description
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.
- Conditions
- Malignant Bone Tumors
- Being tested
- Radiation (Surgical Arm), Radiation (Non-surgical Arm), Malignant Tumor Surgery
- Keywords
- Malignant bone tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation (Surgical Arm)Radiation
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)
Radiation (Non-surgical Arm)Radiation
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)
Malignant Tumor SurgeryProcedure or surgery
Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
| Study group | Role | What they receive |
|---|---|---|
| Non Surgical-Radiation Only | Experimental | Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Receives: Radiation: Radiation (Non-surgical Arm) |
| Malignant Tumor Surgery And Radiation | Experimental | The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, 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). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Receives: Radiation: Radiation (Surgical Arm); Procedure: Malignant Tumor Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Non-surgical arm: baseline, 3 months Surgical arm: baseline, 9 weeks
Secondary outcomes (13)
Serum N-Telopeptide (NTX)
Indicator for Bone Formation, units reported in nmol NTX/mmol creatinine
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 25-hydroxycalciferol Vit D (25-OH VitD)
Indicators for systemic metabolism that can affect bone health, units reported in nmol/L
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJul 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant Bone TumorsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Schwab, Joseph H., Massachusetts General Hospital
- Investigators
- Joseph H. Schwab, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323295
- Sponsor's protocol ID
- 14-208
- Other IDs
- C06CA059267
- Status last verified
- Nov 2021
- First submitted
- 21 Nov 2014
- Last updated
- 7 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02323295
- Acronym / sponsor ID
- 14-208
- Conditions
- Malignant Bone Tumors
- Keywords
- Malignant bone tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2015
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Posted 7 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Surgical-Radiation Only | Experimental | Radiation: Radiation (Non-surgical Arm)Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma |
| Malignant Tumor Surgery And Radiation | Experimental | Radiation: Radiation (Surgical Arm), Procedure: Malignant Tumor SurgeryThe standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, 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). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All laboratory tests that are a part of the eligibility criteria must be completed within 14 days prior to the date of registration. Diagnostic tests that are a part of the eligibility criteria must be performed within 30 days of the date of registration. Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Study participants must have histologically confirmed primary malignant bone tumor in the sacrum for which surgery and radiation or radiation alone are planned.
- Age 18 years or older. In children under the age of 8, tetracycline derivatives have been reported to stain tooth enamel yellow color. These considerations lead us to exclude young persons under the age of 18 from the study.
- Participants must have normal organ and marrow function as defined below:
- The effects of tetracyclines and radiation used in computer tomography on the developing human fetus are known to be detrimental. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Key exclusion criteria (5 listed)
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Participants who have had surgery, chemotherapy, or radiotherapy of the sacrum prior to entering the study
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to tetracyclines.
- Pregnant or nursing
- Uncontrolled inter current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation (Surgical Arm)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) | Radiation | Malignant Tumor Surgery And Radiation |
| Radiation (Non-surgical Arm)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) | Radiation | Non Surgical-Radiation Only |
| Malignant Tumor SurgerySurgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor | Procedure or surgery | Malignant Tumor Surgery And Radiation |
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.
13 secondary outcomes
Serum N-Telopeptide (NTX)
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)
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)
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)
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)
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 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
Mineral Apposition Rate (MAR)
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)
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)
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)
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)
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)
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)
Time frame: Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph H. Schwab, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation (Surgical Arm), Radiation (Non-surgical Arm) and Malignant Tumor Surgery in people with Malignant Bone Tumors, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bone Mineral Density (Tb. BMD) (time frame: Non-surgical arm: baseline, 3 months Surgical arm: baseline, 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.