An interventional study of Biopsy and Chest Computed Tomography in Adult Pleomorphic Rhabdomyosarcoma, AJCC Grade 2 Sarcoma and AJCC Grade 3 Sarcoma, sponsored by ECOG-ACRIN Cancer Research Group. Not yet recruiting. Open to participants aged 1 Year to 85 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by ECOG-ACRIN Cancer Research Group · Not applicable, Interventional, and Diagnostic
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 OBJECTIVE:
I. To evaluate whether the use of chest x-ray (CXR) for lung metastasis surveillance for the first five years after resection of a truncal or extremity soft tissue sarcoma is comparable to the use of chest computed tomography (CT) in terms of overall survival.
SECONDARY OBJECTIVES:
I. To evaluate whether the use of CXR for lung metastasis surveillance for the first five years after resection of a truncal or extremity soft tissue sarcoma is comparable to the use of CT in terms of disease-free survival.
II. To assess the primary and secondary objectives in the pediatric and adolescent and young adult subpopulations.
III. To assess overall survival difference between arms based on specific histiotypes in subgroup analysis.
IV. Patient-reported outcomes and quality of life IVa. Fear of cancer; IVb. Anxiety; IVc. Overall quality of life; IVd. Financial burden; IVe. Patient-reported direct and indirect costs associated with care received.
IMAGING OBJECTIVES (EXPLORATORY):
I. To assess whether CT-derived and CXR-derived radiomic features can be used to determine whether a pulmonary nodule is benign or malignant (metastasis).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo CXR every 3 months for years 1-2, and every 6 months years 3-5. Patients with a suspicious or new nodule undergo a CT and may undergo a biopsy on study.
ARM B: Patients undergo chest CT every 3 months for years 1-2, and every 6 months years 3-5. Patients with a suspicious or new nodule may undergo a biopsy on study.
38 studies on the registry are indexed under Sarcoma, Alveolar Soft Part; 10 are open to participants now.
This study's planned enrollment of 1,582 is above the median of 40 across 35 interventional studies indexed under Sarcoma, Alveolar Soft Part.
Browse Sarcoma, Alveolar Soft Part studies →ECOG-ACRIN Cancer Research Group is the lead sponsor of 121 studies on the registry; 14 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.
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Inclusion Criteria:
Patient must have a high-risk (grade 2 or 3) soft tissue carcinoma according to the French Federation of Cancer Centers Sarcoma Group (FNCLCC)
Patient must not be pregnant due to the potential harmful risks associated with CXR and CT imaging to the unborn fetus
Patient must be English speaking to be eligible for the quality of life (QOL) component of the study
Patients undergo CXR every 3 months for years 1-2, and every 6 months years 3-5. Patients with a suspicious or new nodule undergo a CT and may undergo a biopsy on study.
Procedure: Biopsy · Procedure: Chest Computed Tomography · Procedure: Chest Radiography · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Patients undergo chest CT every 3 months for years 1-2, and every 6 months years 3-5. Patients with a suspicious or new nodule may undergo a biopsy on study.
Procedure: Biopsy · Procedure: Chest Computed Tomography · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Undergo biopsy
Also known as: BIOPSY_TYPE, Bx
Undergo chest CT
Also known as: Chest CT, Computed Tomography of the Chest
Undergo CXR
Also known as: Chest X-ray
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
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.
Time frame: up to 5 years
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.
Time frame: 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 .
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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;
Time frame: 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?
Time frame: 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
Time frame: baseline and every 6 month up to 5 years
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.
Time frame: Up to 5 years of imaging protocol
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