Trial Outcomes & Findings for Effect of High Doses of Radiation on Bone Structure and Metabolism (NCT NCT02323295)
NCT ID: NCT02323295
Last Updated: 2021-12-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Non-surgical arm: baseline, 3 months Surgical arm: baseline, 9 weeks
Results posted on
2021-12-07
Participant Flow
Participant milestones
| Measure |
Non Surgical-Radiation Only
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
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) 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 Surgery And Radiation
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
10
|
|
Overall Study
COMPLETED
|
2
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Non Surgical-Radiation Only
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
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) 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 Surgery And Radiation
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Patient did not have surgery as planned.
|
0
|
1
|
Baseline Characteristics
Effect of High Doses of Radiation on Bone Structure and Metabolism
Baseline characteristics by cohort
| Measure |
Non Surgical-Radiation Only
n=2 Participants
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
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) 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 Surgery And Radiation
n=10 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Non-surgical arm: baseline, 3 months Surgical arm: baseline, 9 weeksPopulation: Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column.
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.
Outcome measures
| Measure |
Non Surgical-Radiation Only
n=2 Participants
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
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) 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 Surgery And Radiation
n=7 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 2 (lumbar)
|
—
|
4.5 mg/cm^3
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 2 (sacral)
|
—
|
-39.3 mg/cm^3
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 3 (lumbar)
|
—
|
-8.7 mg/cm^3
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 3 (sacral)
|
—
|
-54.7 mg/cm^3
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 4 (lumbar)
|
4.1 mg/cm^3
|
—
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 4 (sacral)
|
5.2 mg/cm^3
|
—
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 6 (lumbar)
|
—
|
-2.6 mg/cm^3
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 6 (sacral)
|
—
|
-32.7 mg/cm^3
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 7 (lumbar)
|
—
|
3.6 mg/cm^3
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 7 (sacral)
|
—
|
-14.8 mg/cm^3
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 8 (lumbar)
|
—
|
-2.2 mg/cm^3
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 8 (sacral)
|
—
|
-57.7 mg/cm^3
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 9 (lumbar)
|
-3.5 mg/cm^3
|
—
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 9 (sacral)
|
-55.7 mg/cm^3
|
—
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 10 (lumbar)
|
—
|
-0.2 mg/cm^3
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 10 (sacral)
|
—
|
-70.3 mg/cm^3
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 12 (lumbar)
|
—
|
3.3 mg/cm^3
|
|
Change in Bone Mineral Density (Tb. BMD)
Subject 12 (sacral)
|
—
|
-37.9 mg/cm^3
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column. For other missing values, certain tests were not performed at certain timepoints for some subjects.
Indicator for Bone Formation, units reported in nmol NTX/mmol creatinine
Outcome measures
| Measure |
Non Surgical-Radiation Only
n=2 Participants
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
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) 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 Surgery And Radiation
n=7 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Serum N-Telopeptide (NTX)
Subject 2 (baseline)
|
—
|
21.711 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 2 (5.5 weeks)
|
—
|
17.76 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 2 (18.5 Weeks)
|
—
|
31.447 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 2 (about 7 months)
|
—
|
24.376 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 2 (about 10 months)
|
—
|
21.889 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 3 (baseline)
|
—
|
11.217 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 3 (5.5 weeks)
|
—
|
14.294 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 4 (baseline)
|
4.614 nM/L
|
—
|
|
Serum N-Telopeptide (NTX)
Subject 4 (3.5 weeks)
|
7.366 nM/L
|
—
|
|
Serum N-Telopeptide (NTX)
Subject 4 (7 weeks)
|
6.205 nM/L
|
—
|
|
Serum N-Telopeptide (NTX)
Subject 4 (about 8 months)
|
7.218 nM/L
|
—
|
|
Serum N-Telopeptide (NTX)
Subject 6 (baseline)
|
—
|
15.932 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 6 (5.5 weeks)
|
—
|
19.973 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 6 (18.5 weeks)
|
—
|
20.922 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 6 (about 7 months)
|
—
|
16.707 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 6 (about 10 months)
|
—
|
14.096 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 7 (baseline)
|
—
|
15.949 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 7 (5.5 weeks)
|
—
|
8.942 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 7 (18.5 weeks)
|
—
|
25.817 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 7 (about 10 months)
|
—
|
18.513 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 8 (baseline)
|
—
|
11.97 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 8 (5.5 weeks)
|
—
|
19.065 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 8 (18.5 weeks)
|
—
|
22.917 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 8 (about 7 months)
|
—
|
26.767 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 8 (about 10 months)
|
—
|
18.116 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 9 (baseline)
|
8.028 nM/L
|
—
|
|
Serum N-Telopeptide (NTX)
Subject 9 (3.5 weeks)
|
12.435 nM/L
|
—
|
|
Serum N-Telopeptide (NTX)
Subject 9 (7 weeks)
|
7.642 nM/L
|
—
|
|
Serum N-Telopeptide (NTX)
Subject 9 (about 5 months)
|
11.163 nM/L
|
—
|
|
Serum N-Telopeptide (NTX)
Subject 9 (about 8 months)
|
11.155 nM/L
|
—
|
|
Serum N-Telopeptide (NTX)
Subject 10 (baseline)
|
—
|
11.082 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 10 (5.5 weeks)
|
—
|
7.763 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 10 (18.5 weeks)
|
—
|
10.123 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 10 (about 7 months)
|
—
|
9.89 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 12 (baseline)
|
—
|
12.656 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 12 (5.5 weeks)
|
—
|
10.511 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 12 (18.5 weeks)
|
—
|
14.693 nM/L
|
|
Serum N-Telopeptide (NTX)
Subject 12 (about 7 months)
|
—
|
15.177 nM/L
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column. For other missing values, certain tests were not performed at certain timepoints for some subjects.
Indicator for Bone Formation, units reported in U/L
Outcome measures
| Measure |
Non Surgical-Radiation Only
n=2 Participants
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
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) 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 Surgery And Radiation
n=7 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 4 (7 weeks)
|
3.22168 U/L
|
—
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 2 (baseline)
|
—
|
3.823813 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 2 (5.5 weeks)
|
—
|
3.503794 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 2 (18.5 Weeks)
|
—
|
4.465143 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 2 (about 7 months)
|
—
|
4.226845 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 2 (about 10 months)
|
—
|
3.87936 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 3 (baseline)
|
—
|
4.235948 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 3 (5.5 weeks)
|
—
|
5.111555 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 4 (baseline)
|
2.951546 U/L
|
—
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 4 (3.5 weeks)
|
3.597596 U/L
|
—
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 4 (about 8 months)
|
2.830882 U/L
|
—
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 6 (baseline)
|
—
|
5.482747 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 6 (5.5 weeks)
|
—
|
4.700929 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 6 (18.5 weeks)
|
—
|
6.675976 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 6 (about 7 months)
|
—
|
4.910525 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 6 (about 10 months)
|
—
|
3.99912 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 7 (baseline)
|
—
|
5.051881 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 7 (5.5 weeks)
|
—
|
4.211249 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 7 (18.5 weeks)
|
—
|
5.499551 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 7 (about 10 months)
|
—
|
3.725495 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 8 (baseline)
|
—
|
3.890646 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 8 (5.5 weeks)
|
—
|
4.353515 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 8 (18.5 weeks)
|
—
|
5.2026 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 8 (about 7 months)
|
—
|
5.025804 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 8 (about 10 months)
|
—
|
3.984603 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 9 (baseline)
|
2.461792 U/L
|
—
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 9 (3.5 weeks)
|
2.601314 U/L
|
—
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 9 (7 weeks)
|
3.056594 U/L
|
—
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 9 (about 5 months)
|
3.203289 U/L
|
—
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 9 (about 8 months)
|
2.194518 U/L
|
—
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 10 (baseline)
|
—
|
3.122802 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 10 (5.5 weeks)
|
—
|
2.776157 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 10 (18.5 weeks)
|
—
|
3.329006 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 10 (about 7 months)
|
—
|
2.496301 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 12 (baseline)
|
—
|
3.702653 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 12 (5.5 weeks)
|
—
|
3.986177 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 12 (18.5 weeks)
|
—
|
3.969791 U/L
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Subject 12 (about 7 months)
|
—
|
3.615732 U/L
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column. For other missing values, certain tests were not performed at certain timepoints for some subjects.
Indicator for Bone Formation, units reported in ng/mL
Outcome measures
| Measure |
Non Surgical-Radiation Only
n=2 Participants
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
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) 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 Surgery And Radiation
n=7 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Serum Osteocalcin (OC)
Subject 2 (baseline)
|
—
|
14.304331 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 2 (5.5 weeks)
|
—
|
14.398441 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 2 (18.5 Weeks)
|
—
|
39.41674 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 2 (about 7 months)
|
—
|
24.231676 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 2 (about 10 months)
|
—
|
18.05678 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 3 (baseline)
|
—
|
31.395938 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 3 (5.5 weeks)
|
—
|
16.128416 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 4 (baseline)
|
7.70232 ng/mL
|
—
|
|
Serum Osteocalcin (OC)
Subject 4 (3.5 weeks)
|
8.504592 ng/mL
|
—
|
|
Serum Osteocalcin (OC)
Subject 4 (7 weeks)
|
10.025644 ng/mL
|
—
|
|
Serum Osteocalcin (OC)
Subject 4 (about 8 months)
|
10.54423 ng/mL
|
—
|
|
Serum Osteocalcin (OC)
Subject 6 (baseline)
|
—
|
10.954567 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 6 (5.5 weeks)
|
—
|
12.869497 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 6 (18.5 weeks)
|
—
|
13.061037 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 6 (about 7 months)
|
—
|
25.763047 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 6 (about 10 months)
|
—
|
18.419998 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 7 (baseline)
|
—
|
4.378182 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 7 (5.5 weeks)
|
—
|
10.369156 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 7 (18.5 weeks)
|
—
|
40.882969 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 7 (about 10 months)
|
—
|
28.262384 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 8 (baseline)
|
—
|
13.966 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 8 (5.5 weeks)
|
—
|
16.786965 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 8 (18.5 weeks)
|
—
|
32.353007 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 8 (about 7 months)
|
—
|
29.73705 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 8 (about 10 months)
|
—
|
26.099775 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 9 (baseline)
|
12.220099 ng/mL
|
—
|
|
Serum Osteocalcin (OC)
Subject 9 (3.5 weeks)
|
12.368649 ng/mL
|
—
|
|
Serum Osteocalcin (OC)
Subject 9 (7 weeks)
|
10.955072 ng/mL
|
—
|
|
Serum Osteocalcin (OC)
Subject 9 (about 5 months)
|
11.167479 ng/mL
|
—
|
|
Serum Osteocalcin (OC)
Subject 9 (about 8 months)
|
10.028165 ng/mL
|
—
|
|
Serum Osteocalcin (OC)
Subject 10 (baseline)
|
—
|
12.321595 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 10 (5.5 weeks)
|
—
|
14.881427 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 10 (18.5 weeks)
|
—
|
19.861684 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 10 (about 7 months)
|
—
|
16.437832 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 12 (baseline)
|
—
|
17.549564 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 12 (5.5 weeks)
|
—
|
17.154958 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 12 (18.5 weeks)
|
—
|
11.480525 ng/mL
|
|
Serum Osteocalcin (OC)
Subject 12 (about 7 months)
|
—
|
16.409198 ng/mL
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column. For other missing values, certain tests were not performed at certain timepoints for some subjects.
Indicator for systemic metabolism that can affect bone health, units reported in pg/mL
Outcome measures
| Measure |
Non Surgical-Radiation Only
n=2 Participants
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
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) 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 Surgery And Radiation
n=7 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 2 (baseline)
|
—
|
42.826123 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 2 (5.5 weeks)
|
—
|
34.128407 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 2 (18.5 Weeks)
|
—
|
123.860111 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 2 (about 7 months)
|
—
|
74.655436 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 2 (about 10 months)
|
—
|
68.966468 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 3 (baseline)
|
—
|
72.946381 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 3 (5.5 weeks)
|
—
|
44.08789 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 4 (baseline)
|
21.375865 pg/mL
|
—
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 4 (3.5 weeks)
|
28.095207 pg/mL
|
—
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 4 (7 weeks)
|
32.953174 pg/mL
|
—
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 4 (about 8 months)
|
43.37268 pg/mL
|
—
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 6 (baseline)
|
—
|
129.054174 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 6 (5.5 weeks)
|
—
|
83.031563 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 6 (18.5 weeks)
|
—
|
152.713648 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 6 (about 7 months)
|
—
|
186.103683 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 6 (about 10 months)
|
—
|
93.061044 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 7 (baseline)
|
—
|
13.875913 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 7 (5.5 weeks)
|
—
|
40.4564 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 7 (18.5 weeks)
|
—
|
135.28581 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 7 (about 10 months)
|
—
|
98.31769 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 8 (baseline)
|
—
|
39.183829 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 8 (5.5 weeks)
|
—
|
56.609907 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 8 (18.5 weeks)
|
—
|
219.86073 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 8 (about 7 months)
|
—
|
129.372101 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 8 (about 10 months)
|
—
|
99.637646 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 9 (baseline)
|
51.29302 pg/mL
|
—
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 9 (3.5 weeks)
|
38.642487 pg/mL
|
—
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 9 (7 weeks)
|
40.145122 pg/mL
|
—
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 9 (about 5 months)
|
42.945924 pg/mL
|
—
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 9 (about 8 months)
|
33.200638 pg/mL
|
—
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 10 (baseline)
|
—
|
53.568154 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 10 (5.5 weeks)
|
—
|
59.57128 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 10 (18.5 weeks)
|
—
|
114.083432 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 10 (about 7 months)
|
—
|
59.498204 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 12 (baseline)
|
—
|
47.539351 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 12 (5.5 weeks)
|
—
|
50.82762 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 12 (18.5 weeks)
|
—
|
72.878306 pg/mL
|
|
Serum Type 1 Procollagen N-terminal (P1NP)
Subject 12 (about 7 months)
|
—
|
64.002627 pg/mL
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column. For other missing values, certain tests were not performed at certain timepoints for some subjects.
Indicators for systemic metabolism that can affect bone health, units reported in mg/dL
Outcome measures
| Measure |
Non Surgical-Radiation Only
n=2 Participants
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
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) 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 Surgery And Radiation
n=7 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Serum Phosphate (P)
Subject 10 (baseline)
|
—
|
2.4 mg/dL
|
|
Serum Phosphate (P)
Subject 10 (5.5 weeks)
|
—
|
4.0 mg/dL
|
|
Serum Phosphate (P)
Subject 10 (18.5 weeks)
|
—
|
3.5 mg/dL
|
|
Serum Phosphate (P)
Subject 10 (about 7 months)
|
—
|
2.2 mg/dL
|
|
Serum Phosphate (P)
Subject 12 (baseline)
|
—
|
4.2 mg/dL
|
|
Serum Phosphate (P)
Subject 12 (5.5 weeks)
|
—
|
3.7 mg/dL
|
|
Serum Phosphate (P)
Subject 2 (baseline)
|
—
|
3.9 mg/dL
|
|
Serum Phosphate (P)
Subject 2 (5.5 weeks)
|
—
|
3.5 mg/dL
|
|
Serum Phosphate (P)
Subject 2 (18.5 Weeks)
|
—
|
4.0 mg/dL
|
|
Serum Phosphate (P)
Subject 2 (about 7 months)
|
—
|
3.6 mg/dL
|
|
Serum Phosphate (P)
Subject 2 (about 10 months)
|
—
|
3.7 mg/dL
|
|
Serum Phosphate (P)
Subject 3 (baseline)
|
—
|
4.4 mg/dL
|
|
Serum Phosphate (P)
Subject 3 (5.5 weeks)
|
—
|
4.3 mg/dL
|
|
Serum Phosphate (P)
Subject 4 (baseline)
|
2.8 mg/dL
|
—
|
|
Serum Phosphate (P)
Subject 4 (3.5 weeks)
|
3.0 mg/dL
|
—
|
|
Serum Phosphate (P)
Subject 4 (7 weeks)
|
3.0 mg/dL
|
—
|
|
Serum Phosphate (P)
Subject 4 (about 8 months)
|
3.2 mg/dL
|
—
|
|
Serum Phosphate (P)
Subject 6 (baseline)
|
—
|
3.4 mg/dL
|
|
Serum Phosphate (P)
Subject 6 (5.5 weeks)
|
—
|
3.3 mg/dL
|
|
Serum Phosphate (P)
Subject 6 (18.5 weeks)
|
—
|
4.4 mg/dL
|
|
Serum Phosphate (P)
Subject 6 (about 7 months)
|
—
|
4.1 mg/dL
|
|
Serum Phosphate (P)
Subject 6 (about 10 months)
|
—
|
3.6 mg/dL
|
|
Serum Phosphate (P)
Subject 7 (baseline)
|
—
|
3.3 mg/dL
|
|
Serum Phosphate (P)
Subject 7 (5.5 weeks)
|
—
|
4.0 mg/dL
|
|
Serum Phosphate (P)
Subject 7 (18.5 weeks)
|
—
|
4.9 mg/dL
|
|
Serum Phosphate (P)
Subject 7 (about 10 months)
|
—
|
4.0 mg/dL
|
|
Serum Phosphate (P)
Subject 8 (baseline)
|
—
|
3.3 mg/dL
|
|
Serum Phosphate (P)
Subject 8 (5.5 weeks)
|
—
|
3.3 mg/dL
|
|
Serum Phosphate (P)
Subject 8 (18.5 weeks)
|
—
|
3.5 mg/dL
|
|
Serum Phosphate (P)
Subject 8 (about 7 months)
|
—
|
3.7 mg/dL
|
|
Serum Phosphate (P)
Subject 8 (about 10 months)
|
—
|
3.3 mg/dL
|
|
Serum Phosphate (P)
Subject 9 (baseline)
|
4.3 mg/dL
|
—
|
|
Serum Phosphate (P)
Subject 9 (3.5 weeks)
|
4.0 mg/dL
|
—
|
|
Serum Phosphate (P)
Subject 9 (7 weeks)
|
4.7 mg/dL
|
—
|
|
Serum Phosphate (P)
Subject 9 (about 5 months)
|
4.2 mg/dL
|
—
|
|
Serum Phosphate (P)
Subject 9 (about 8 months)
|
3.4 mg/dL
|
—
|
|
Serum Phosphate (P)
Subject 12 (18.5 weeks)
|
—
|
3.4 mg/dL
|
|
Serum Phosphate (P)
Subject 12 (about 7 months)
|
—
|
3.4 mg/dL
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column. For other missing values, certain tests were not performed at certain timepoints for some subjects.
Indicators for systemic metabolism that can affect bone health, units reported in nmol/L
Outcome measures
| Measure |
Non Surgical-Radiation Only
n=2 Participants
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
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) 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 Surgery And Radiation
n=7 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 2 (baseline)
|
—
|
36.065991 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 2 (5.5 weeks)
|
—
|
32.073769 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 2 (18.5 Weeks)
|
—
|
31.302671 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 2 (about 7 months)
|
—
|
36.77789 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 2 (about 10 months)
|
—
|
33.419347 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 3 (baseline)
|
—
|
17.038722 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 3 (5.5 weeks)
|
—
|
12.739664 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 4 (baseline)
|
60.483526 nmol/L
|
—
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 4 (3.5 weeks)
|
50.942045 nmol/L
|
—
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 4 (7 weeks)
|
38.703589 nmol/L
|
—
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 4 (about 8 months)
|
62.317379 nmol/L
|
—
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 6 (baseline)
|
—
|
36.051246 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 6 (5.5 weeks)
|
—
|
35.309918 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 6 (18.5 weeks)
|
—
|
36.748899 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 6 (about 7 months)
|
—
|
32.918895 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 6 (about 10 months)
|
—
|
36.262804 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 7 (baseline)
|
—
|
17.740625 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 7 (5.5 weeks)
|
—
|
17.258697 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 7 (18.5 weeks)
|
—
|
27.862934 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 7 (about 10 months)
|
—
|
20.845497 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 8 (baseline)
|
—
|
23.596514 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 8 (5.5 weeks)
|
—
|
22.190329 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 8 (18.5 weeks)
|
—
|
27.355142 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 8 (about 7 months)
|
—
|
29.649107 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 8 (about 10 months)
|
—
|
25.399281 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 9 (baseline)
|
39.515148 nmol/L
|
—
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 9 (3.5 weeks)
|
39.281166 nmol/L
|
—
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 9 (7 weeks)
|
40.21479 nmol/L
|
—
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 9 (about 5 months)
|
41.193903 nmol/L
|
—
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 9 (about 8 months)
|
47.316427 nmol/L
|
—
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 10 (baseline)
|
—
|
30.093394 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 10 (5.5 weeks)
|
—
|
30.491835 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 10 (18.5 weeks)
|
—
|
27.330808 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 10 (about 7 months)
|
—
|
28.958284 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 12 (baseline)
|
—
|
18.366566 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 12 (5.5 weeks)
|
—
|
25.333837 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 12 (18.5 weeks)
|
—
|
31.425202 nmol/L
|
|
Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Subject 12 (about 7 months)
|
—
|
32.557435 nmol/L
|
SECONDARY outcome
Timeframe: 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.Population: B = before radiation, A = after radiation. For missing values, certain tests were not performed at certain timepoints for some subjects.
Tetracycline quadruple labeling method will be used and the unit of measure will be um/day
Outcome measures
| Measure |
Non Surgical-Radiation Only
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
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) 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 Surgery And Radiation
n=7 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Mineral Apposition Rate (MAR)
Subject 2 (Iliac Crest, Cancellous, B)
|
—
|
0.64 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 2 (iliac Crest, Cancellous, A)
|
—
|
0.66 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 2 (Iliac Crest, Endocortical, B)
|
—
|
0.55 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 2 (Iliac Crest, Endocortical, A)
|
—
|
0.71 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 2 (Iliac Crest, Intracortical, B)
|
—
|
0.72 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 2 (Iliac Crest, Intracortical, A)
|
—
|
0.44 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 2 (Sacrum, Cancellous, B)
|
—
|
0.58 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 2 (Sacrum, Cancellous, A)
|
—
|
0.45 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 2 (Sacrum, Endocortical, B)
|
—
|
0.70 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 2 (Sacrum, Intracortical, B)
|
—
|
0.47 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 2 (Sacrum, Periosteal, B)
|
—
|
1.50 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 2 (Sacrum, Periosteal, A)
|
—
|
0.98 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 3 (Iliac Crest, Cancellous, B)
|
—
|
0.64 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 3 (Iliac Crest, Cancellous, A)
|
—
|
0.54 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 3 (Iliac Crest, Endocortical, B)
|
—
|
0.53 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 3 (Iliac Crest, Endocortical, A)
|
—
|
0.46 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 3 (Iliac Crest, Intracortical, B)
|
—
|
0.64 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 3 (Iliac Crest, Intracortical, A)
|
—
|
0.59 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 3 (Sacrum, Cancellous, B)
|
—
|
0.62 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 3 (Sacrum, Cancellous, A)
|
—
|
0.34 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 6 (Iliac Crest, Cancellous, B)
|
—
|
0.51 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 6 (Iliac Crest, Cancellous, A)
|
—
|
0.40 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 6 (Iliac Crest, Endocortical, B)
|
—
|
0.51 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 6 (Iliac Crest, Endocortical, A)
|
—
|
0.43 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 6 (Iliac Crest, Intracortical, B)
|
—
|
1.12 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 6 (Iliac Crest, Intracortical, A)
|
—
|
0.50 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 6 (Sacrum, Cancellous, B)
|
—
|
0.51 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 6 (Sacrum, Cancellous, A)
|
—
|
0.37 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 6 (Sacrum, Endocortical, B)
|
—
|
0.55 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 6 (Sacrum, Endocortical, A)
|
—
|
0.18 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 7 (Iliac Crest, Cancellous, B)
|
—
|
0.65 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 7 (Iliac Crest, Cancellous, A)
|
—
|
0.72 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 7 (Iliac Crest, Endocortical, A)
|
—
|
0.48 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 7 (Iliac Crest, Intracortical, B)
|
—
|
1.20 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 7 (Iliac Crest, Periosteal, B)
|
—
|
0.33 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 7 (Iliac Crest, Periosteal, A)
|
—
|
0.47 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 7 (Sacrum, Cancellous, B)
|
—
|
0.69 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 7 (Sacrum, Cancellous, A)
|
—
|
0.59 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 7 (Sacrum, Endocortical, B)
|
—
|
0.41 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 7 (Sacrum, Endocortical, A)
|
—
|
0.76 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 7 (Sacrum, Intracortical, B)
|
—
|
0.92 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 7 (Sacrum, Intracortical, A)
|
—
|
0.68 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 8 (Iliac Crest, Cancellous, B)
|
—
|
0.62 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 8 (Iliac Crest, Cancellous, A)
|
—
|
0.43 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 8 (Iliac Crest, Endocortical, B)
|
—
|
0.51 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 8 (Iliac Crest, Endocortical, A)
|
—
|
0.33 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 8 (Iliac Crest, Intracortical, B)
|
—
|
1.83 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 8 (Iliac Crest, Intracortical, A)
|
—
|
0.73 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 8 (Sacrum, Cancellous, B)
|
—
|
0.56 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 10 (Iliac Crest, Cancellous, B)
|
—
|
0.60 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 10 (Iliac Crest, Cancellous, A)
|
—
|
0.40 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 10 (Iliac Crest, Endocortical, B)
|
—
|
0.42 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 10 (Iliac Crest, Endocortical, A)
|
—
|
0.41 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 10 (Iliac Crest, Intracortical, B)
|
—
|
0.49 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 10 (Iliac Crest, Intracortical, A)
|
—
|
0.53 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 10 (Sacrum, Cancellous, B)
|
—
|
0.50 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 10 (Sacrum, Cancellous, A)
|
—
|
0.49 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 10 (Sacrum, Endocortical, B)
|
—
|
0.44 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 10 (Sacrum, Intracortical, B)
|
—
|
0.60 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 12 (Iliac Crest, Cancellous, B)
|
—
|
0.53 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 12 (Iliac Crest, Endocortical, B)
|
—
|
0.48 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 12 (Iliac Crest, Intracortical, B)
|
—
|
0.96 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 12 (Sacrum, Cancellous, B)
|
—
|
0.47 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 12 (Sacrum, Endocortical, B)
|
—
|
0.50 um/day
|
|
Mineral Apposition Rate (MAR)
Subject 12 (Sacrum, Intracortical, B)
|
—
|
1.31 um/day
|
SECONDARY outcome
Timeframe: 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.Population: B = before radiation, A = after radiation. For missing values, certain tests were not performed at certain timepoints for some subjects.
Tetracycline quadruple labeling method will be used and the unit of measure will be mm3/mm2/year
Outcome measures
| Measure |
Non Surgical-Radiation Only
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
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) 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 Surgery And Radiation
n=7 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Bone Formation Rate (BFR/BS)
Subject 2 (Iliac Crest, Cancellous, B)
|
—
|
0.003 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 2 (iliac Crest, Cancellous, A)
|
—
|
0.003 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 2 (Iliac Crest, Endocortical, B)
|
—
|
0.013 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 2 (Iliac Crest, Endocortical, A)
|
—
|
0.013 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 2 (Iliac Crest, Intracortical, B)
|
—
|
0.014 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 2 (Iliac Crest, Intracortical, A)
|
—
|
0.013 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 2 (Iliac Crest, Periosteal, B)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 2 (Iliac Crest, Periosteal, A)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 2 (Sacrum, Cancellous, B)
|
—
|
0.007 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 2 (Sacrum, Cancellous, A)
|
—
|
0.001 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 2 (Sacrum, Endocortical, B)
|
—
|
0.052 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 2 (Sacrum, Intracortical, B)
|
—
|
0.053 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 2 (Sacrum, Intracortical, A)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 2 (Sacrum, Periosteal, B)
|
—
|
0.012 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 2 (Sacrum, Periosteal, A)
|
—
|
0.004 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 3 (Iliac Crest, Cancellous, B)
|
—
|
0.016 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 3 (Iliac Crest, Cancellous, A)
|
—
|
0.012 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 3 (Iliac Crest, Endocortical, B)
|
—
|
0.021 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 3 (Iliac Crest, Endocortical, A)
|
—
|
0.009 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 3 (Iliac Crest, Intracortical, B)
|
—
|
0.047 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 3 (Iliac Crest, Intracortical, A)
|
—
|
0.032 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 3 (Iliac Crest, Periosteal, B)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 3 (Iliac Crest, Periosteal, A)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 3 (Sacrum, Cancellous, B)
|
—
|
0.009 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 3 (Sacrum, Cancellous, A)
|
—
|
0.001 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Iliac Crest, Cancellous, B)
|
—
|
0.005 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Iliac Crest, Cancellous, A)
|
—
|
0.006 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Iliac Crest, Endocortical, B)
|
—
|
0.019 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Iliac Crest, Endocortical, A)
|
—
|
0.024 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Iliac Crest, Intracortical, B)
|
—
|
0.029 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Iliac Crest, Intracortical, A)
|
—
|
0.041 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Iliac Crest, Periosteal, B)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Iliac Crest, Periosteal, A)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Sacrum, Cancellous, B)
|
—
|
0.003 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Sacrum, Cancellous, A)
|
—
|
0.001 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Sacrum, Endocortical, B)
|
—
|
0.010 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Sacrum, Endocortical, A)
|
—
|
0.001 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Sacrum, Intracortical, B)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Sacrum, Intracortical, A)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Sacrum, Periosteal, B)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 6 (Sacrum, Periosteal, A)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 7 (Iliac Crest, Cancellous, B)
|
—
|
0.012 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 7 (Iliac Crest, Cancellous, A)
|
—
|
0.031 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 7 (Iliac Crest, Endocortical, A)
|
—
|
0.004 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 7 (Iliac Crest, Intracortical, B)
|
—
|
0.057 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 7 (Iliac Crest, Periosteal, B)
|
—
|
0.007 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 7 (Iliac Crest, Periosteal, A)
|
—
|
0.036 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 7 (Sacrum, Cancellous, B)
|
—
|
0.011 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 7 (Sacrum, Cancellous, A)
|
—
|
0.007 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 7 (Sacrum, Endocortical, B)
|
—
|
0.004 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 7 (Sacrum, Endocortical, A)
|
—
|
0.007 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 7 (Sacrum, Intracortical, B)
|
—
|
0.004 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 7 (Sacrum, Intracortical, A)
|
—
|
0.002 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 7 (Sacrum, Periosteal, B)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 7 (Sacrum, Periosteal, A)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 8 (Iliac Crest, Cancellous, B)
|
—
|
0.004 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 8 (Iliac Crest, Cancellous, A)
|
—
|
0.001 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 8 (Iliac Crest, Endocortical, B)
|
—
|
0.016 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 8 (Iliac Crest, Endocortical, A)
|
—
|
0.007 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 8 (Iliac Crest, Intracortical, B)
|
—
|
0.039 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 8 (Iliac Crest, Intracortical, A)
|
—
|
0.035 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 8 (Iliac Crest, Periosteal, B)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 8 (Iliac Crest, Periosteal, A)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 8 (Sacrum, Cancellous, B)
|
—
|
0.005 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 10 (Iliac Crest, Cancellous, B)
|
—
|
0.022 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 10 (Iliac Crest, Cancellous, A)
|
—
|
0.016 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 10 (Iliac Crest, Endocortical, B)
|
—
|
0.022 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 10 (Iliac Crest, Endocortical, A)
|
—
|
0.030 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 10 (Iliac Crest, Intracortical, B)
|
—
|
0.023 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 10 (Iliac Crest, Intracortical, A)
|
—
|
0.032 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 10 (Iliac Crest, Periosteal, B)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 10 (Iliac Crest, Periosteal, A)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 10 (Sacrum, Cancellous, B)
|
—
|
0.003 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 10 (Sacrum, Cancellous, A)
|
—
|
0.001 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 10 (Sacrum, Endocortical, B)
|
—
|
0.002 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 10 (Sacrum, Intracortical, B)
|
—
|
0.013 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 10 (Sacrum, Periosteal, B)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 10 (Sacrum, Periosteal, A)
|
—
|
0.000 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 12 (Iliac Crest, Cancellous, B)
|
—
|
0.018 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 12 (Iliac Crest, Endocortical, B)
|
—
|
0.028 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 12 (Iliac Crest, Intracortical, B)
|
—
|
0.017 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 12 (Sacrum, Cancellous, B)
|
—
|
0.005 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 12 (Sacrum, Endocortical, B)
|
—
|
0.017 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 12 (Sacrum, Intracortical, B)
|
—
|
0.063 mm3/mm2/year
|
|
Bone Formation Rate (BFR/BS)
Subject 12 (Sacrum, Periosteal, B)
|
—
|
0.000 mm3/mm2/year
|
SECONDARY outcome
Timeframe: 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.Population: A = after radiation. No periosteal data for any subject. For other missing values, certain tests were not performed at certain timepoints for some subjects.
Tetracycline quadruple labeling method will be used and the unit of measure will be days
Outcome measures
| Measure |
Non Surgical-Radiation Only
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
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) 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 Surgery And Radiation
n=7 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Mineralization Lag Time (Mlt)
Subject 7 (Iliac Crest, Endocortical, A)
|
—
|
15.49 days
|
|
Mineralization Lag Time (Mlt)
Subject 7 (Sacrum, Cancellous, A)
|
—
|
34.10 days
|
|
Mineralization Lag Time (Mlt)
Subject 7 (Sacrum, Endocortical, A)
|
—
|
37.18 days
|
|
Mineralization Lag Time (Mlt)
Subject 7 (Sacrum, Intracortical, A)
|
—
|
87.15 days
|
|
Mineralization Lag Time (Mlt)
Subject 8 (Iliac Crest, Cancellous, A)
|
—
|
3.11 days
|
|
Mineralization Lag Time (Mlt)
Subject 8 (Iliac Crest, Endocortical, A)
|
—
|
10.72 days
|
|
Mineralization Lag Time (Mlt)
Subject 8 (Iliac Crest, Intracortical, A)
|
—
|
8.15 days
|
|
Mineralization Lag Time (Mlt)
Subject 10 (Iliac Crest, Cancellous, A)
|
—
|
63.18 days
|
|
Mineralization Lag Time (Mlt)
Subject 10 (Iliac Crest, Endocortical, A)
|
—
|
34.23 days
|
|
Mineralization Lag Time (Mlt)
Subject 10 (Iliac Crest, Intracortical, A)
|
—
|
26.65 days
|
|
Mineralization Lag Time (Mlt)
Subject 10 (Sacrum, Cancellous, A)
|
—
|
142.08 days
|
|
Mineralization Lag Time (Mlt)
Subject 2 (iliac Crest, Cancellous, A)
|
—
|
40.77 days
|
|
Mineralization Lag Time (Mlt)
Subject 2 (Iliac Crest, Endocortical, A)
|
—
|
15.47 days
|
|
Mineralization Lag Time (Mlt)
Subject 2 (Iliac Crest, Intracortical, A)
|
—
|
12.56 days
|
|
Mineralization Lag Time (Mlt)
Subject 2 (Sacrum, Cancellous, A)
|
—
|
68.10 days
|
|
Mineralization Lag Time (Mlt)
Subject 3 (Iliac Crest, Cancellous, A)
|
—
|
21.70 days
|
|
Mineralization Lag Time (Mlt)
Subject 3 (Iliac Crest, Endocortical, A)
|
—
|
41.88 days
|
|
Mineralization Lag Time (Mlt)
Subject 3 (Iliac Crest, Intracortical, A)
|
—
|
20.33 days
|
|
Mineralization Lag Time (Mlt)
Subject 3 (Sacrum, Cancellous, A)
|
—
|
7.45 days
|
|
Mineralization Lag Time (Mlt)
Subject 6 (Iliac Crest, Cancellous, A)
|
—
|
24.98 days
|
|
Mineralization Lag Time (Mlt)
Subject 6 (Iliac Crest, Endocortical, A)
|
—
|
13.31 days
|
|
Mineralization Lag Time (Mlt)
Subject 6 (Iliac Crest, Intracortical, A)
|
—
|
16.36 days
|
|
Mineralization Lag Time (Mlt)
Subject 6 (Sacrum, Cancellous, A)
|
—
|
110.51 days
|
|
Mineralization Lag Time (Mlt)
Subject 6 (Sacrum, Endocortical, A)
|
—
|
40.28 days
|
|
Mineralization Lag Time (Mlt)
Subject 7 (Iliac Crest, Cancellous, A)
|
—
|
16.28 days
|
SECONDARY outcome
Timeframe: Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).Population: No biopsy data for subjects 10 and 12.
Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1
Outcome measures
| Measure |
Non Surgical-Radiation Only
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
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) 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 Surgery And Radiation
n=7 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Osteoblast Number (N.Ob/BPm)
Subject 2 (week 5)
|
—
|
0.26 1/mm
|
|
Osteoblast Number (N.Ob/BPm)
Subject 2 (week 6)
|
—
|
0.05 1/mm
|
|
Osteoblast Number (N.Ob/BPm)
Subject 3 (week 5)
|
—
|
1.25 1/mm
|
|
Osteoblast Number (N.Ob/BPm)
Subject 3 (week 6)
|
—
|
0.05 1/mm
|
|
Osteoblast Number (N.Ob/BPm)
Subject 6 (week 5)
|
—
|
1.04 1/mm
|
|
Osteoblast Number (N.Ob/BPm)
Subject 6 (week 6)
|
—
|
0.19 1/mm
|
|
Osteoblast Number (N.Ob/BPm)
Subject 7 (week 5)
|
—
|
6.23 1/mm
|
|
Osteoblast Number (N.Ob/BPm)
Subject 7 (week 6)
|
—
|
1.89 1/mm
|
|
Osteoblast Number (N.Ob/BPm)
Subject 8 (week 5)
|
—
|
0.05 1/mm
|
|
Osteoblast Number (N.Ob/BPm)
Subject 8 (week 6)
|
—
|
0.16 1/mm
|
SECONDARY outcome
Timeframe: Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).Population: No biopsy data for subjects 10 and 12.
Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1
Outcome measures
| Measure |
Non Surgical-Radiation Only
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
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) 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 Surgery And Radiation
n=7 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Osteoblast Surface (Ob. S/BS)
Subject 2 (week 5)
|
—
|
0.58 1/mm
|
|
Osteoblast Surface (Ob. S/BS)
Subject 2 (week 6)
|
—
|
0.10 1/mm
|
|
Osteoblast Surface (Ob. S/BS)
Subject 3 (week 5)
|
—
|
2.38 1/mm
|
|
Osteoblast Surface (Ob. S/BS)
Subject 3 (week 6)
|
—
|
0.07 1/mm
|
|
Osteoblast Surface (Ob. S/BS)
Subject 6 (week 5)
|
—
|
1.63 1/mm
|
|
Osteoblast Surface (Ob. S/BS)
Subject 6 (week 6)
|
—
|
0.29 1/mm
|
|
Osteoblast Surface (Ob. S/BS)
Subject 7 (week 5)
|
—
|
9.07 1/mm
|
|
Osteoblast Surface (Ob. S/BS)
Subject 7 (week 6)
|
—
|
2.71 1/mm
|
|
Osteoblast Surface (Ob. S/BS)
Subject 8 (week 5)
|
—
|
0.05 1/mm
|
|
Osteoblast Surface (Ob. S/BS)
Subject 8 (week 6)
|
—
|
0.23 1/mm
|
SECONDARY outcome
Timeframe: Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).Population: No biopsy data for subjects 10 and 12.
Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1
Outcome measures
| Measure |
Non Surgical-Radiation Only
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
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) 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 Surgery And Radiation
n=7 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Osteoclast Number (N.Oc/BPm)
Subject 2 (week 5)
|
—
|
0.02 1/mm
|
|
Osteoclast Number (N.Oc/BPm)
Subject 2 (week 6)
|
—
|
0.00 1/mm
|
|
Osteoclast Number (N.Oc/BPm)
Subject 3 (week 5)
|
—
|
0.03 1/mm
|
|
Osteoclast Number (N.Oc/BPm)
Subject 3 (week 6)
|
—
|
0.01 1/mm
|
|
Osteoclast Number (N.Oc/BPm)
Subject 6 (week 5)
|
—
|
0.08 1/mm
|
|
Osteoclast Number (N.Oc/BPm)
Subject 6 (week 6)
|
—
|
0.02 1/mm
|
|
Osteoclast Number (N.Oc/BPm)
Subject 7 (week 5)
|
—
|
0.10 1/mm
|
|
Osteoclast Number (N.Oc/BPm)
Subject 7 (week 6)
|
—
|
0.31 1/mm
|
|
Osteoclast Number (N.Oc/BPm)
Subject 8 (week 5)
|
—
|
0 1/mm
|
|
Osteoclast Number (N.Oc/BPm)
Subject 8 (week 6)
|
—
|
0.07 1/mm
|
SECONDARY outcome
Timeframe: Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).Population: No biopsy data for subjects 10 and 12.
Immunohistochemistry staining methods will be used and the unit of measure will be mm\^-1
Outcome measures
| Measure |
Non Surgical-Radiation Only
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
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) 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 Surgery And Radiation
n=7 Participants
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
Osteoclast Surface (Oc.S/BS)
Subject 2 (week 5)
|
—
|
0.12 1/mm
|
|
Osteoclast Surface (Oc.S/BS)
Subject 2 (week 6)
|
—
|
0.00 1/mm
|
|
Osteoclast Surface (Oc.S/BS)
Subject 3 (week 5)
|
—
|
0.11 1/mm
|
|
Osteoclast Surface (Oc.S/BS)
Subject 3 (week 6)
|
—
|
0.02 1/mm
|
|
Osteoclast Surface (Oc.S/BS)
Subject 6 (week 5)
|
—
|
0.36 1/mm
|
|
Osteoclast Surface (Oc.S/BS)
Subject 6 (week 6)
|
—
|
0.12 1/mm
|
|
Osteoclast Surface (Oc.S/BS)
Subject 7 (week 5)
|
—
|
0.44 1/mm
|
|
Osteoclast Surface (Oc.S/BS)
Subject 7 (week 6)
|
—
|
1.27 1/mm
|
|
Osteoclast Surface (Oc.S/BS)
Subject 8 (week 5)
|
—
|
0.00 1/mm
|
|
Osteoclast Surface (Oc.S/BS)
Subject 8 (week 6)
|
—
|
0.29 1/mm
|
Adverse Events
Non Surgical-Radiation Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Malignant Tumor Surgery And Radiation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non Surgical-Radiation Only
n=2 participants at risk
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
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) 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 Surgery And Radiation
n=10 participants at risk
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.
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) 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 Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
|
|---|---|---|
|
General disorders
Allergic reaction
|
0.00%
0/2 • From first dose of study treatment to final study date per patient, approximately 10 months.
|
10.0%
1/10 • Number of events 1 • From first dose of study treatment to final study date per patient, approximately 10 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place