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NCT00589121 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2019-06-12

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Local Failure Rate at Two Years

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outcome · POSTED

Regional Failure Rate at Two Years

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outcome · POSTED

Distant Failure Rate at Two Years

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outcome · POSTED

Distant Disease-free Survival Rate at Two Years

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outcome · POSTED

Disease-free Survival Rate at Two Years

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outcome · POSTED

Overall Survival Rate at Two Years

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outcome · POSTED

Second Primary Tumor Rate at Two Years

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outcome · POSTED

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

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outcome · POSTED

Percentage of Patients With Wound Complications

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outcome · POSTED

Pattern of First Failure

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outcome · POSTED

Mean Musculoskeletal Tumor Rating Scale (MSTS) by Late Radiation Morbidity at Two Years

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outcome · POSTED

Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events

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outcome · NOT POSTED

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)]

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outcome · NOT POSTED

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]

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outcome · NOT POSTED

Comparison of SAQ Scores at 2 Years for Cohort A Patients With Cohort B Patients

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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
    intervention Names
    1. Drug: Chemotherapy
    2. Radiation: Radiation therapy
    3. Procedure: Surgery
    label
    Cohort A - Chemotherapy
    type
    EXPERIMENTAL
  2. description
    Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
    intervention Names
    1. Radiation: Radiation therapy
    2. Procedure: Surgery
    label
    Cohort B - No Chemotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Cohort A - Chemotherapy
    description
    Up to 6 courses of investigator's choice of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy
    name
    Chemotherapy
    type
    DRUG
  2. arm Group Labels
    1. Cohort A - Chemotherapy
    2. Cohort B - No Chemotherapy
    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.
    name
    Radiation therapy
    type
    RADIATION
  3. arm Group Labels
    1. Cohort A - Chemotherapy
    2. Cohort B - No Chemotherapy
    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.
    name
    Surgery
    type
    PROCEDURE
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
98
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. measure
    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)
  2. measure
    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)
  3. measure
    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)
primary Outcomes
  1. 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.
    measure
    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
    time Frame
    2 years after start of treatment (+/- 3 months)
secondary Outcomes
  1. 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.
    measure
    Local Failure Rate at Two Years
    time Frame
    From registration to date of failure (local progression) or death or last follow-up. Report at time of primary outcome measure analysis.
  2. 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.
    measure
    Regional Failure Rate at Two Years
    time Frame
    From registration to date of failure (regional progression) or death or last follow-up. Report at time of primary outcome measure analysis.
  3. 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.
    measure
    Distant Failure Rate at Two Years
    time Frame
    From registration to date of failure (distant progression) or death or last follow-up. Report at time of primary outcome measure analysis.
  4. 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.
    measure
    Distant Disease-free Survival Rate at Two Years
    time Frame
    From registration to date of failure (distant progression or death) or last follow-up. Report at time of primary outcome measure analysis.
  5. 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.
    measure
    Disease-free Survival Rate at Two Years
    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.
  6. 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.
    measure
    Overall Survival Rate at Two Years
    time Frame
    From registration to date of death or last follow-up. Report at time of primary outcome measure analysis.
  7. 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.
    measure
    Second Primary Tumor Rate at Two Years
    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.
  8. 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.
    measure
    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
    time Frame
    2 years after start of treatment (+/- 3 months)
  9. description
    Estimate rate of patients with acute wound complications with 95% confidence interval assuming binomial distribution.
    measure
    Percentage of Patients With Wound Complications
    time Frame
    From date of surgery to 4 months post-surgery
  10. description
    Pattern of first failure including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression.
    measure
    Pattern of First Failure
    time Frame
    From registration to date of local, regional or distant progression. Report at time of primary outcome measure analysis.
  11. 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.
    measure
    Mean Musculoskeletal Tumor Rating Scale (MSTS) by Late Radiation Morbidity at Two Years
    time Frame
    From start of treatment to 2 years.
  12. 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.
    measure
    Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events
    time Frame
    From start of treatment to last follow-up. Analysis can occur at or after time of primary outcome measure analysis.
Full 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.
Source references
references
  1. citation
    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.
    pmid
    36995690
    type
    DERIVED
  2. 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.
    pmid
    25667281
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        combined analysis of the <a href="/clinicaltrials/NCT00002791">RTOG-9514</a> study (NCT00002791) of neoadjuvant chemoradiation and the <a href="/clinicaltrials/NCT00589121">RTOG-0630</a> study (NCT00589121) of neoadjuvant radiation therapy showed rates of pathological complete response of 27.5% in patients on neoadjuvant chemora
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        /clinicaltrials/NCT00002791">RTOG-9514</a> study (NCT00002791) of neoadjuvant chemoradiation and the <a href="/clinicaltrials/NCT00589121">RTOG-0630</a> study (NCT00589121) of neoadjuvant radiation therapy showed rates of pathological complete response of 27.5% in patients on neoadjuvant chemoradiation and 19.4% in patients on n
        end
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        NCT00589121
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      source title
      Soft Tissue Sarcoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 21, 2025
        datetime
        2025-02-21T12:00:00Z
        display
        February 21, 2025

    Preserved source evidence · Not medical advice