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Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg

Primary Purpose

Lymphedema, Musculoskeletal Complications, Radiation Fibrosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Chemotherapy
Radiation therapy
Surgery
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring radiation fibrosis, radiation toxicity, lymphedema, musculoskeletal complications, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, adult extraskeletal chondrosarcoma, stage III adult soft tissue sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary soft tissue sarcoma of the upper extremity (including shoulder) or lower extremity (including hip)

    • Incisional or core biopsy required within the past 8 weeks

  • 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

      • Extraskeletal myxoid chondrosarcoma allowed

  • Tumor must be surgically resectable, as determined by a surgeon within the past 8 weeks

    • Limb-preservation surgery alone would not provide adequate local control, as determined by the surgeon
  • 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

      • The maximum dimension of the primary tumor is measured in MRI images

    • CT scan of the chest

      • Multiple pulmonary nodules < 8 mm without a histological diagnosis detected incidentally on a non-screening CT scan may be allowed
    • 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

      • HIV testing not required

  • No NCI CTCAE v 3.0 grade 3-4 electrolyte abnormalities, including any of the following*:

    • Calcium < 7 mg/dL or > 12.5 mg/dL
    • Glucose < 40 mg/dL or > 250 mg/dL
    • Magnesium < 0.9 mg/dL or > 3 mg/dL
    • Potassium < 3mmol/L or > 6 mmol/L
    • Sodium < 130 mmol/L or > 155 mmol/L NOTE: *Applies to group 1 only, which was closed to accrual as of 01/08/10)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior excisional biopsy in which the majority of the tumor (≥ 50%) is removed
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
  • No other concurrent investigational agents

Sites / Locations

  • CCOP - Christiana Care Health Services
  • University of Florida Shands Cancer Center
  • Mayo Clinic - Jacksonville
  • University of Miami Sylvester Comprehensive Cancer Center - Miami
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • Norton Suburban Hospital
  • Massachusetts General Hospital
  • William Beaumont Hospital - Royal Oak Campus
  • Mayo Clinic Cancer Center
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Roswell Park Cancer Institute
  • Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
  • Norris Cotton Cancer Center - North
  • Medical College of Wisconsin Cancer Center
  • Cross Cancer Institute at University of Alberta
  • London Regional Cancer Program at London Health Sciences Centre
  • McGill Cancer Centre at McGill University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort A - Chemotherapy

Cohort B - No Chemotherapy

Arm Description

Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost

Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
Percentage of Patients With Wound Complications
Estimate rate of patients with acute wound complications with 95% confidence interval assuming binomial distribution.
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.
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.
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.

Full Information

First Posted
January 5, 2008
Last Updated
June 3, 2019
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00589121
Brief Title
Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg
Official Title
A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2008 (Actual)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
May 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: Primary To determine the effect of reduced radiation volume using image-guided radiotherapy (IGRT) on lymphedema ≥ grade 2, subcutaneous fibrosis, and joint stiffness at 2 years in patients with primary soft tissue sarcoma of the extremity. Secondary To estimate the rates of other grade 3-5 adverse events as measured by Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. To determine the pattern of first failure, including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression. To estimate the rates of local failure, local-regional failure, distant failure, distant disease-free survival, disease-free survival, overall survival, and second primary tumor. To estimate the rate of wound complications. To correlate the degree of late radiation morbidity (defined as any lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years with scores on the clinical measure, Musculoskeletal Tumor Rating Scale (MSTS). 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). Group 1 (closed to accrual as of 01/08/10): Patients undergo 3-D conformal radiotherapy (3D-CRT) or intensity-modulated therapy (IMRT) once daily, 5 days a week, for 4½-5 weeks. Patients also receive up to 6 courses of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy. Group 2: Patients undergo 3D-CRT or IMRT once daily, 5 days a week, for 5 weeks. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Musculoskeletal Complications, Radiation Fibrosis, Radiation Toxicity, Sarcoma
Keywords
radiation fibrosis, radiation toxicity, lymphedema, musculoskeletal complications, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, adult extraskeletal chondrosarcoma, stage III adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A - Chemotherapy
Arm Type
Experimental
Arm Description
Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Arm Title
Cohort B - No Chemotherapy
Arm Type
Experimental
Arm Description
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Up to 6 courses of investigator's choice of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
2 years after start of treatment (+/- 3 months)
Secondary Outcome Measure Information:
Title
Local Failure Rate at Two Years
Description
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.
Time Frame
From registration to date of failure (local progression) or death or last follow-up. Report at time of primary outcome measure analysis.
Title
Regional Failure Rate at Two Years
Description
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.
Time Frame
From registration to date of failure (regional progression) or death or last follow-up. Report at time of primary outcome measure analysis.
Title
Distant Failure Rate at Two Years
Description
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.
Time Frame
From registration to date of failure (distant progression) or death or last follow-up. Report at time of primary outcome measure analysis.
Title
Distant Disease-free Survival Rate at Two Years
Description
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.
Time Frame
From registration to date of failure (distant progression or death) or last follow-up. Report at time of primary outcome measure analysis.
Title
Disease-free Survival Rate at Two Years
Description
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.
Time Frame
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.
Title
Overall Survival Rate at Two Years
Description
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.
Time Frame
From registration to date of death or last follow-up. Report at time of primary outcome measure analysis.
Title
Second Primary Tumor Rate at Two Years
Description
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.
Time Frame
From registration to date of failure (second primary tumor) or death or last follow-up. Report at time of primary outcome measure analysis.
Title
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
Description
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.
Time Frame
2 years after start of treatment (+/- 3 months)
Title
Percentage of Patients With Wound Complications
Description
Estimate rate of patients with acute wound complications with 95% confidence interval assuming binomial distribution.
Time Frame
From date of surgery to 4 months post-surgery
Title
Pattern of First Failure
Description
Pattern of first failure including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression.
Time Frame
From registration to date of local, regional or distant progression. Report at time of primary outcome measure analysis.
Title
Mean Musculoskeletal Tumor Rating Scale (MSTS) by Late Radiation Morbidity at Two Years
Description
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.
Time Frame
From start of treatment to 2 years.
Title
Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events
Description
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.
Time Frame
From start of treatment to last follow-up. Analysis can occur at or after time of primary outcome measure analysis.
Other Pre-specified Outcome Measures:
Title
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)]
Time Frame
2 years after start of treatment (+/- 3 months)
Title
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]
Time Frame
2 years after start of treatment (+/- 3 months)
Title
Comparison of SAQ Scores at 2 Years for Cohort A Patients With Cohort B Patients
Time Frame
2 years after start of treatment (+/- 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary soft tissue sarcoma of the upper extremity (including shoulder) or lower extremity (including hip) Incisional or core biopsy required within the past 8 weeks 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 Extraskeletal myxoid chondrosarcoma allowed Tumor must be surgically resectable, as determined by a surgeon within the past 8 weeks Limb-preservation surgery alone would not provide adequate local control, as determined by the surgeon 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 The maximum dimension of the primary tumor is measured in MRI images CT scan of the chest Multiple pulmonary nodules < 8 mm without a histological diagnosis detected incidentally on a non-screening CT scan may be allowed 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 HIV testing not required No NCI CTCAE v 3.0 grade 3-4 electrolyte abnormalities, including any of the following*: Calcium < 7 mg/dL or > 12.5 mg/dL Glucose < 40 mg/dL or > 250 mg/dL Magnesium < 0.9 mg/dL or > 3 mg/dL Potassium < 3mmol/L or > 6 mmol/L Sodium < 130 mmol/L or > 155 mmol/L NOTE: *Applies to group 1 only, which was closed to accrual as of 01/08/10) PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior excisional biopsy in which the majority of the tumor (≥ 50%) is removed No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dian Wang, MD, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Okuno, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Burton L. Eisenberg, MD
Organizational Affiliation
Norris Cotton Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John M. Kane, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David G. Kirsch, MD, PhD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0232
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Norton Suburban Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Norris Cotton Cancer Center - North
City
Saint Johnsbury
State/Province
Vermont
ZIP/Postal Code
05819
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Cross Cancer Institute at University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
London Regional Cancer Program at London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
McGill Cancer Centre at McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25667281
Citation
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.
Results Reference
derived

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Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg

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