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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000582196 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
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RATIONALE: Image-guided radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a lower dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying the side effects and how well image-guided radiation therapy works in treating patients with primary soft tissue sarcoma of the shoulder, arm, hip, or leg.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Neoadjuvant radiotherapy: Patients are assigned to 1 of 2 treatment groups (group 1 closed to accrual as of 01/08/10).
Surgery: At 4-8 weeks after completion of neoadjuvant radiotherapy, patients undergo surgical resection of the tumor. Patients with positive tumor margins (residual tumor) undergo intraoperative radiotherapy boost or proceed to adjuvant radiotherapy within 2 weeks after surgery.
Adjuvant radiotherapy: Patients undergo either external-beam radiotherapy (EBRT) once daily for 8 fractions or brachytherapy.
After completion of study treatment, patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A - Chemotherapy | Experimental | Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost |
|
| Cohort B - No Chemotherapy | Experimental | Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | Up to 6 courses of investigator's choice of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by EORTC/RTOG Criteria | The rate of patients with late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC(European Organisation for Research and Treatment of Cancer)/RTOG (Radiation Therapy Oncology Group) criteria. Grade refers to the severity of the morbidity. The RTOG/EORTC Late Radiation Morbidity Scoring Schema assigns Grades 1 through 5 with unique clinical descriptions of severity for each morbidity based on this general guideline: Grade 1 Mild , Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to morbidity. | 2 years after start of treatment (+/- 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Local Failure Rate at Two Years | Local failure is defined as the time from registration to date of failure (local progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method. | From registration to date of failure (local progression) or death or last follow-up. Report at time of primary outcome measure analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Late Radiation Morbidity at 2 Years With the 3 Quality of Life Assessments [Functional Assessment of Cancer Therapy-General (FACTG), Toronto Extremity Salvage Score (TESS), and Sexual Adjustment Questionnaire (SAQ)] | 2 years after start of treatment (+/- 3 months) | |
| Comparison of TESS and the MSTS Scores at 2 Years Between Cohort B Patients and the Preoperative Radiotherapy Patients in the NCIC CTG Trial [National Cancer Institute of Canada Clinical Trials Group] |
DISEASE CHARACTERISTICS:
Histologically confirmed primary soft tissue sarcoma of the upper extremity (including shoulder) or lower extremity (including hip)
No histopathological diagnosis of any of the following:
Rhabdomyosarcoma
Extraosseous primitive neuroectodermal tumor (PNET)
Soft tissue Ewing sarcoma
Osteosarcoma
Kaposi sarcoma
Angiosarcoma
Aggressive fibromatosis (desmoid tumor)
Dermatofibrosarcoma protuberans
Chondrosarcoma
Tumor must be surgically resectable, as determined by a surgeon within the past 8 weeks
No sarcoma of the hand, foot, head, neck, or intra-abdominal or retroperitoneal region or body wall
No sarcoma ≥ 32 cm in any direction
No lymph node or distant metastases, according to the following within the past 8 weeks:
History/physical examination, including a detailed description of the location, size, and stage of the sarcoma
MRI with contrast of the primary tumor
CT scan of the chest
CT scan with contrast of the abdomen and pelvis in patients with intermediate- or high-grade sarcoma of the upper thigh
No recurrent tumor after prior potentially curative therapy
PATIENT CHARACTERISTICS:
Zubrod performance status 0-1
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
Bilirubin ≤ 1.5 mg/dL*
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2 times upper limit of normal*
Serum creatinine ≤ 1.6 mg/dL OR creatinine clearance ≥ 55 mL/min*
Left ventricular ejection fraction (LVEF) ≥ 50% by multiple gated acquisition scan (MUGA) or echocardiogram*
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other invasive malignancy within the past 3 years, except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
No severe, active co-morbidity, including any of the following*:
Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
Transmural myocardial infarction within the past 6 months
Acute bacterial infection or fungal infection requiring intravenous antibiotics
Acquired Immune Deficiency Syndrome (AIDS) or immunocompromised patients
No NCI CTCAE v 3.0 grade 3-4 electrolyte abnormalities, including any of the following*:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Dian Wang, MD, PhD | Medical College of Wisconsin | Principal Investigator |
| Scott Okuno, MD | Mayo Clinic | Study Chair |
| Burton L. Eisenberg, MD | Norris Cotton Cancer Center | Study Chair |
| John M. Kane, MD | Roswell Park Cancer Institute | Study Chair |
| David G. Kirsch, MD, PhD | Duke Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States | ||
| University of Florida Shands Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36995690 | Derived | Wang D, Harris J, Kraybill WG, Eisenberg B, Kirsch DG, Ettinger DS, Kane JM 3rd, Barry PN, Naghavi A, Freeman CR, Chen YL, Hitchcock YJ, Bedi M, Salerno KE, Severin D, Godette KD, Larrier NA, Curran WJ Jr, Torres-Saavedra PA, Lucas DR. Pathologic Complete Response and Clinical Outcomes in Patients With Localized Soft Tissue Sarcoma Treated With Neoadjuvant Chemoradiotherapy or Radiotherapy: The NRG/RTOG 9514 and 0630 Nonrandomized Clinical Trials. JAMA Oncol. 2023 May 1;9(5):646-655. doi: 10.1001/jamaoncol.2023.0042. | |
| 25667281 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A - Chemotherapy | Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost |
| FG001 | Cohort B - No Chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Radiation therapy | Radiation | Preoperative IGRT (3D-CRT or IMRT): If receiving neoadjuvant or adjuvant chemotherapy or no chemotherapy: 50 Gy (2 Gy once a day, 5 times a week). If receiving concurrent or interdigitated chemotherapy: 44 Gy (2 Gy once a day, 5 times a week). Postoperative radiotherapy boost for patients with positive margins following surgery: 16 Gy (2 Gy once a day, 5 times a week) external beam radiation therapy or 16 Gy at ≤ 80 cGy per hour brachytherapy or 3.4 Gy/fraction in 4 fractions brachytherapy or 10-12.5 Gy in a single fraction intraoperative radiation therapy boost. |
|
| Surgery | Procedure | Resection of the sarcoma with the goal of having negative pathologic margins. Every effort should be made to have limb preservation surgery unless there is documented evidence of tumor progression that would require amputation for an appropriate negative margin resection. All lesions of the extremities should be treated with wide excision. |
|
| Regional Failure Rate at Two Years | Regional failure is defined as the time from registration to date of failure (regional progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method. | From registration to date of failure (regional progression) or death or last follow-up. Report at time of primary outcome measure analysis. |
| Distant Failure Rate at Two Years | Distant failure is defined as the time from registration to date of failure (distant progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method. | From registration to date of failure (distant progression) or death or last follow-up. Report at time of primary outcome measure analysis. |
| Distant Disease-free Survival Rate at Two Years | Distant disease-free survival is defined as the time from registration to date of failure (distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method. | From registration to date of failure (distant progression or death) or last follow-up. Report at time of primary outcome measure analysis. |
| Disease-free Survival Rate at Two Years | Disease-free survival is defined as the time from registration to date of failure (local, regional, or distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method. | From registration to date of failure (local, regional or distant progression or death) or last follow-up. Report at time of primary outcome measure analysis. |
| Overall Survival Rate at Two Years | Overall survival is defined as the time from registration to date of death or last follow-up. Two year survival rate and 95% confidence interval were estimated by the Kaplan-Meier method. | From registration to date of death or last follow-up. Report at time of primary outcome measure analysis. |
| Second Primary Tumor Rate at Two Years | Second primary tumor is defined as the time from registration to date of failure (second primary tumor) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method. | From registration to date of failure (second primary tumor) or death or last follow-up. Report at time of primary outcome measure analysis. |
| Late Radiation Morbidity Rate (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by CTCAE v3.0 | Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | 2 years after start of treatment (+/- 3 months) |
| Percentage of Patients With Wound Complications | Estimate rate of patients with acute wound complications with 95% confidence interval assuming binomial distribution. | From date of surgery to 4 months post-surgery |
| Pattern of First Failure | Pattern of first failure including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression. | From registration to date of local, regional or distant progression. Report at time of primary outcome measure analysis. |
| Mean Musculoskeletal Tumor Rating Scale (MSTS) by Late Radiation Morbidity at Two Years | The Musculoskeletal Tumor Rating Scale (MSTS) is a measure of physical function across 7 items, completed by the physician (preferably by the Orthopedic Surgeon or Surgical Oncologist) or the physician's designated staff. The 7 items are: pain, range of motion, strength, joint stability, joint deformity, emotional, acceptance, and overall function. Each item is scored from 0-5 (worst possible to best possible condition). The item scores are summed to get the total score which ranges from 0-35. Late radiation morbidity is defined as ≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | From start of treatment to 2 years. |
| Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events | Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | From start of treatment to last follow-up. Analysis can occur at or after time of primary outcome measure analysis. |
| 2 years after start of treatment (+/- 3 months) |
| Comparison of SAQ Scores at 2 Years for Cohort A Patients With Cohort B Patients | 2 years after start of treatment (+/- 3 months) |
| Gainesville |
| Florida |
| 32610-0232 |
| United States |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa | Florida | 33612-9497 | United States |
| Norton Suburban Hospital | Louisville | Kentucky | 40207 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | 48073 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Norris Cotton Cancer Center - North | Saint Johnsbury | Vermont | 05819 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Cross Cancer Institute at University of Alberta | Edmonton | Alberta | T6G 1Z2 | Canada |
| London Regional Cancer Program at London Health Sciences Centre | London | Ontario | N6A 4L6 | Canada |
| McGill Cancer Centre at McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| Derived |
| Wang D, Zhang Q, Eisenberg BL, Kane JM, Li XA, Lucas D, Petersen IA, DeLaney TF, Freeman CR, Finkelstein SE, Hitchcock YJ, Bedi M, Singh AK, Dundas G, Kirsch DG. Significant Reduction of Late Toxicities in Patients With Extremity Sarcoma Treated With Image-Guided Radiation Therapy to a Reduced Target Volume: Results of Radiation Therapy Oncology Group RTOG-0630 Trial. J Clin Oncol. 2015 Jul 10;33(20):2231-8. doi: 10.1200/JCO.2014.58.5828. Epub 2015 Feb 9. |
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All eligible patients who started protocol treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A - Chemotherapy | Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost |
| BG001 | Cohort B - No Chemotherapy | Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by EORTC/RTOG Criteria | The rate of patients with late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC(European Organisation for Research and Treatment of Cancer)/RTOG (Radiation Therapy Oncology Group) criteria. Grade refers to the severity of the morbidity. The RTOG/EORTC Late Radiation Morbidity Scoring Schema assigns Grades 1 through 5 with unique clinical descriptions of severity for each morbidity based on this general guideline: Grade 1 Mild , Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to morbidity. | All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.) | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years after start of treatment (+/- 3 months) |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Local Failure Rate at Two Years | Local failure is defined as the time from registration to date of failure (local progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method. | All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.) | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to date of failure (local progression) or death or last follow-up. Report at time of primary outcome measure analysis. |
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| Secondary | Regional Failure Rate at Two Years | Regional failure is defined as the time from registration to date of failure (regional progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method. | All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.) | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to date of failure (regional progression) or death or last follow-up. Report at time of primary outcome measure analysis. |
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| Secondary | Distant Failure Rate at Two Years | Distant failure is defined as the time from registration to date of failure (distant progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method. | All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.) | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to date of failure (distant progression) or death or last follow-up. Report at time of primary outcome measure analysis. |
|
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| Secondary | Distant Disease-free Survival Rate at Two Years | Distant disease-free survival is defined as the time from registration to date of failure (distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method. | All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.) | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to date of failure (distant progression or death) or last follow-up. Report at time of primary outcome measure analysis. |
|
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| Secondary | Disease-free Survival Rate at Two Years | Disease-free survival is defined as the time from registration to date of failure (local, regional, or distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method. | All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.) | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to date of failure (local, regional or distant progression or death) or last follow-up. Report at time of primary outcome measure analysis. |
|
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| Secondary | Overall Survival Rate at Two Years | Overall survival is defined as the time from registration to date of death or last follow-up. Two year survival rate and 95% confidence interval were estimated by the Kaplan-Meier method. | All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.) | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to date of death or last follow-up. Report at time of primary outcome measure analysis. |
|
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| Secondary | Second Primary Tumor Rate at Two Years | Second primary tumor is defined as the time from registration to date of failure (second primary tumor) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method. | All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.) | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to date of failure (second primary tumor) or death or last follow-up. Report at time of primary outcome measure analysis. |
|
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| Secondary | Late Radiation Morbidity Rate (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by CTCAE v3.0 | Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.) | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years after start of treatment (+/- 3 months) |
|
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| Secondary | Percentage of Patients With Wound Complications | Estimate rate of patients with acute wound complications with 95% confidence interval assuming binomial distribution. | All eligible patients on cohort B that had surgery and a wound assessment. (See limitations and caveats, Cohort A is not included.) | Posted | Number | 95% Confidence Interval | percentage of participants | From date of surgery to 4 months post-surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pattern of First Failure | Pattern of first failure including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression. | All eligible patients on Cohort B who started study treatment. All eligible patients on Cohort B. (See limitations and caveats, Cohort A is not included.) | Posted | Number | participants | From registration to date of local, regional or distant progression. Report at time of primary outcome measure analysis. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Musculoskeletal Tumor Rating Scale (MSTS) by Late Radiation Morbidity at Two Years | The Musculoskeletal Tumor Rating Scale (MSTS) is a measure of physical function across 7 items, completed by the physician (preferably by the Orthopedic Surgeon or Surgical Oncologist) or the physician's designated staff. The 7 items are: pain, range of motion, strength, joint stability, joint deformity, emotional, acceptance, and overall function. Each item is scored from 0-5 (worst possible to best possible condition). The item scores are summed to get the total score which ranges from 0-35. Late radiation morbidity is defined as ≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | All eligible patients on Cohort B who had a 2-year MSTS assessment. (See limitations and caveats, Cohort A is not included.) | Posted | Mean | Standard Deviation | units on a scale | From start of treatment to 2 years. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events | Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.) | Posted | Number | 95% Confidence Interval | percentage of patients | From start of treatment to last follow-up. Analysis can occur at or after time of primary outcome measure analysis. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Correlation of Late Radiation Morbidity at 2 Years With the 3 Quality of Life Assessments [Functional Assessment of Cancer Therapy-General (FACTG), Toronto Extremity Salvage Score (TESS), and Sexual Adjustment Questionnaire (SAQ)] | Not Posted | 2 years after start of treatment (+/- 3 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Comparison of TESS and the MSTS Scores at 2 Years Between Cohort B Patients and the Preoperative Radiotherapy Patients in the NCIC CTG Trial [National Cancer Institute of Canada Clinical Trials Group] | Not Posted | 2 years after start of treatment (+/- 3 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Comparison of SAQ Scores at 2 Years for Cohort A Patients With Cohort B Patients | Not Posted | 2 years after start of treatment (+/- 3 months) | Participants |
Not provided
Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A - Chemotherapy | Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost | 2 | 10 | 8 | 10 | ||
| EG001 | Cohort B - No Chemotherapy | Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost | 13 | 79 | 73 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection [other] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Opportunistic infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Skin infection [with normal or Grade 1-2 ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Wound infection [with normal or Grade 1-2 ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Arterial injury - Extremity-lower | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: subcutaneous tissue: NOS | Injury, poisoning and procedural complications | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Postoperative hemorrhage | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Laboratory test abnormal | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Joint disorder | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Late RT Toxicity: joint: NOS | Musculoskeletal and connective tissue disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vascular disorder | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Premature ventricular contractions | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gait abnormal | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| General symptom | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ill-defined disorder | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Localized edema [trunk/genital] | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain [NOS] | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain [other] | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Stern's Scale Toxicity: edema: NOS | General disorders | Stern's Edema Scale | Systematic Assessment |
| |
| Gastric infection [with unknown ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection [other] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Skin infection [with normal or Grade 1-2 ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Wound infection [with normal or Grade 1-2 ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Wound infection [with unknown ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: subcutaneous tissue: NOS | Injury, poisoning and procedural complications | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Postoperative hemorrhage | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperbilirubinemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Laboratory test abnormal | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Buttock pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Joint disorder | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Joint disorder | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: joint: NOS | Musculoskeletal and connective tissue disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Phantom pain | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Taste alteration | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gynecomastia | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage nasal | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vascular disorder | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Due to unmet accrual goals for Cohort A, the decision was made to close this cohort and to increase the sample size of Cohort B. Due to the small sample size for Cohort A results were not reported.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld, M.S. | NRG Oncology | seiferheldw@nrgoncology.org |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D000087525 | Radiation Fibrosis Syndrome |
| D011832 | Radiation Injuries |
| D012509 | Sarcoma |
| C563195 | Chondrosarcoma, Extraskeletal Myxoid |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
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