Trials Sponsors Conditions Drugs Pricing

Conditions

Lymphedema Musculoskeletal Complications Radiation Fibrosis Radiation Toxicity Sarcoma

Keywords

radiation fibrosisradiation toxicitylymphedemamusculoskeletal complicationsstage I adult soft tissue sarcomastage II adult soft tissue sarcomaadult extraskeletal chondrosarcomastage III adult soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

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)

Secondary Outcomes (12)

Local Failure Rate at Two Years
From registration to date of failure (local progression) or death or last follow-up. Report at time of primary outcome measure analysis.

Study Arms (2)

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

Drug: ChemotherapyRadiation: Radiation therapyProcedure: Surgery

Cohort B - No Chemotherapy

EXPERIMENTAL

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

Radiation: Radiation therapyProcedure: Surgery

Interventions

ChemotherapyDrug

Up to 6 courses of investigator's choice of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy

Cohort A - Chemotherapy

Radiation therapyRadiation

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

Radiation Therapy Oncology Group
Research networklead
National Cancer Institute (NCI)
NIHcollaborator
NRG Oncology

Study Sites (17)

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

University of Florida Shands Cancer Center

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

Related Publications (2)

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: 36995690DERIVED
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

MeSH Terms

Conditions

LymphedemaRadiation Fibrosis SyndromeRadiation InjuriesSarcomaChondrosarcoma, Extraskeletal Myxoid

Interventions

Drug TherapyRadiotherapySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Limitations and Caveats

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.

Results Point of Contact

Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology

Study Officials

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

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

98 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: NETWORK
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 5, 2008

First Posted

January 9, 2008

Study Start

March 2008

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

Cohort A - Chemotherapy

Cohort B - No Chemotherapy

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (17)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Other Outcomes (3)

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

Cohort A - Chemotherapy

Cohort B - No Chemotherapy

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (17)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Other Outcomes (3)

Intervention Hierarchy (Ancestors)

Source record

Locations