Evaluation of Chest CT Versus Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma
NCT Number: NCT06526897
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adult Pleomorphic Rhabdomyosarcoma|AJCC Grade 2 Sarcoma|AJCC Grade 3 Sarcoma|Alveolar Soft Part Sarcoma|Angiosarcoma|Clear Cell Sarcoma of Soft Tissue|Dedifferentiated Liposarcoma|Extraskeletal Ewing Sarcoma|Extraskeletal Myxoid Chondrosarcoma|Fibrosarcoma|Fibrosarcomatous Dermatofibrosarcoma Protuberans|Leiomyosarcoma|Malignant Peripheral Nerve Sheath Tumor|Myxofibrosarcoma|Pleomorphic Liposarcoma|Round Cell Sarcoma With EWSR1-non-ETS Fusion|Sarcoma|Soft Tissue Sarcoma|Soft Tissue Sarcoma of the Trunk and Extremities|Spindle Cell Sarcoma|Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8|Synovial Sarcoma|Undifferentiated Pleomorphic Sarcoma
Interventions: PROCEDURE: Biopsy|PROCEDURE: Chest Computed Tomography|PROCEDURE: Chest Radiography|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration
Sponsor: ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1582
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2025-01-28
Completion Date: 2032-11-01

Summary:
This phase III trial compares chest computed tomography (CT) to chest x-ray (CXR) for lung surveillance after curative-intent resection of high-risk truncal-extremity soft tissue sarcoma. Currently, complete oncologic resection (with or without radiation therapy) is the standard of care for most high-risk soft tissue sarcoma that has not spread to other parts of the body (localized). However, despite curative-intent resection, 20-40% of patients will develop cancer that has spread from where it first started (primary site) to other places in the body (distant metastases), with the lungs being the most common site. Thus, lung surveillance is important for detection of lung metastases in order to facilitate timely treatment. Although there is general agreement about the usefulness of postoperative surveillance, consensus is lacking regarding the optimal modality for lung surveillance after curative-intent resection for high-risk soft tissue sarcoma. Current National Comprehensive Cancer Network guidelines recommend chest imaging with CT or CXR every 3-6 months for 2-3 years, then every 6 months for the next two years, and then annually after that for high-risk tumors. Data from across the United States and internationally indicate that there is considerable variation in clinical practice with regards to the use of CXR versus CT chest for lung surveillance. The information gained from this trial may allow researchers to determine the effectiveness of varying imaging modalities needed for optimal surveillance for patients with extremity or truncal soft tissue sarcoma.

Primary Outcome Measures: Overall survival (OS), Overall Survival will be evaluated across arms. Survival will be evaluated at least annually from randomization to death or up to 5 years., up to 5 years
Secondary Outcome Measures: Lung disease-free survival, Lung disease-free survival is defined as time from randomization to time of distant lung recurrence. New invasive primary cancer or death from any cause will be censored At each follow-up surveillance examination, data will be collected on symptoms, lung imaging results, and any additional examinations or procedures performed for suspected recurrence. Histopathologically-confirmed recurrences and deaths will be reported at the time of the event., up to 5 years|Overall survival (OS) in the pediatric and adolescent and young adult subpopulations, Overall Survival will be evaluated across arms in the pediatric and adolescent and young adult subpopulations Survival will be evaluated at least annually from randomization to death or up to 5 years ., up to 5 years|Lung disease-free survival in the pediatric and adolescent and young adult subpopulations, Lung disease-free survival is defined as time from randomization to time of distant lung recurrence in the pediatric and adolescent and young adult subpopulations. New invasive primary cancer or death from any cause will be censored At each follow-up surveillance examination, data will be collected on symptoms, lung imaging results, and any additional examinations or procedures performed for suspected recurrence. Histopathologically-confirmed recurrences and deaths will be reported at the time of the event., up to 5 years|Overall Survival (OS) based on specific histiotypes, Will assess assess overall survival difference between arms based on specific histiotypes in subgroup analysis., Up to 5 years of imaging protocol|Fear of cancer as measured by a modified Psychological Consequences Questionnaire (PCQ):, Fear of cancer associated with care received among those assigned to the CT arm compared to the CXR arm Will be measured using a Modified PCQ Response levels are rated on a four-point Likert scale from 0 (not at all) to 3 (quite a lot of the time). .

The sum of scores results in a total fear score between 0 and 36. Higher scores indicate more psychological dysfunction., baseline and every 6 month up to 5 years|PROMIS Anxiety Score, Anxiety will be measured by anxiety associated with care received among those assigned to the CT arm compared to the CXR arm. The 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety, or parent proxy version for those under 18 years of age, will be collected at baseline and every 6 months, up to 5 years during the relevant clinic visit. Anxiety will be modeled as the continuous outcome in the regression models.

Each item on the PROMIS Anxiety measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety., baseline and every 6 month up to 5 years|PROMIS Global-10, Global Health Overall Quality of Life, Overall quality of life (OQOL) will be assessed among those assigned to the CT arm compared to the CXR arm. The PROMIS 10 adult, or parent proxy version for those under 18 years of age, will be collected at baseline and every 6 months, up to 5 years. OQOL will be modeled as the continuous outcome in the regression models.

PROMIS Global-10 is rated on a 5-point (as well as a single 11-point) rating scale. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient., baseline and every 6 month up to 5 years|Financial toxicity from the Comprehensive Score for Financial Toxicity (COST), Financial toxicity is defined as the rating given to a single item from the COST measure "My illness has been a financial hardship to my family and me". The rating is on a 5-point scale (0=Not at All 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very Much) Lower scores indicate greater financial toxicity, while higher scores indicate better financial well-being., baseline and every 6 month up to 5 years|Medical Expenditures Panel Surveys Reduction in material resources, Medical Expenditures Panel Surveys will be used to measure reduction in material resources associated with care received among those assigned to the CT arm compared to the CXR arm.

Reduction in material resources is a binary (Yes/No) outcome if any of the following responses is true:

participant has taken on debt, sold a home, or declared bankruptcy;, baseline and every 6 month up to 5 years|Care non-adherence, Care non-adherence will be measured by care non-adherence associated with care received among those assigned to the CT arm compared to the CXR arm. Care non-adherence is defined as any positive response to the care non-adherence questions:

Did you forego or reduce medication doses due to to financial concerns? Did you forego tests or clinic visits due to financial concerns?, baseline and every 6 month up to 5 years|Patient-reported out-of-pocket and indirect costs of care, Will be measured by patient-reported out-of-pocket and indirect costs of care associated with care received among those assigned to the CT arm compared to the CXR arm. Patients were asked to estimate their out-of-pocket costs at the time of the clinic visit.

in addition to costs out-of-pocket costs for clinic visits, medication, and co-pays, indirect costs will include lost wages, care-giver substitutes, and transportation costs, baseline and every 6 month up to 5 years
Other Outcome Measures: Radiomic features of pulmonary nodules, All imaging from all sites will be collected using the National Cancer Institute Transfer of Images and Data software. Images will be anonymized and saved in the Digital Imaging and Communications in Medicine format. The images will undergo quality assurance evaluation to ensure that the images are appropriate and diagnostic. The aim of this radiomics objective is to identify radiomic features that could be used to accurately determine whether a pulmonary nodule is benign or malignant, thereby potentially obviating the need for pulmonary nodule biopsies in the future. For the radiomics analysis of pulmonary nodules, will analyze the images from the diagnostic CT scan immediately prior to the pulmonary nodule biopsy for biopsied nodules. For nodules that are not biopsied, will utilize the first surveillance CT scan where that nodule was detected. Least absolute shrinkage and selection operator will be utilized to select the radiomic features that best differentiate tumor type., Up to 5 years of imaging protocol