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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-06179 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| EA7201 | Other Identifier | ECOG-ACRIN Cancer Research Group | |
| ECOG-ACRIN-EA7201 | Other Identifier | DCP | |
| EA7201 | Other Identifier | CTEP | |
| UG1CA189828 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (CXR) | Experimental | 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. |
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| Arm B (CT) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Procedure | Undergo biopsy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Patient must be ≥ 1 and ≤ 85 years old on the day of randomization
Patient must have and undergone curative-intent (R0 or R1) resection of an American Joint Committee on Cancer (AJCC) 8th edition stage III truncal or extremity soft tissue sarcoma
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 have a tumor size ≥ 5 cm
Patient must have had a R0 or R1 oncologic resection on final pathologic report
Patient must have a baseline chest CT obtained within 30 days prior to randomization that is negative or detecting only non-suspicious nodules ≤ 4 mm
Patients receiving preoperative or post-operative chemotherapy and/or radiotherapy for the primary tumor are eligible. However, all chemotherapy and/or radiotherapy must be completed prior to randomization
Patient must not be pregnant due to the potential harmful risks associated with CXR and CT imaging to the unborn fetus
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patient must not have a chest wall/upper truncal primary tumor requiring locoregional surveillance with CT or magnetic resonance imaging (MRI)
Patient must not have retroperitoneal, mesenteric/abdominal sarcoma
Patient must not have a primary bone sarcoma (including osteosarcomas, Ewings sarcoma, or chondrosarcomas), desmoid tumor, gastrointestinal stromal tumor (GIST), Kaposi sarcoma, pediatric rhabdomyosarcoma, nor uterine sarcoma
Patient must not have had a palliative or R2 resection
Patient must not require routine cross-sectional imaging of the chest/lungs with CT/MRI/positron emission tomography (PET)
Patient must not have participation in another clinical trial that is incompatible with this study surveillance schema and follow-up regimen
Patient must have the ability to understand and the willingness to sign a written informed consent document. Pediatric patients (< 18 years of age) and patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible. Child assent must be obtained as appropriate in accordance with institutional guidelines
Patient must be English speaking to be eligible for the quality of life (QOL) component of the study
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Cardona | ECOG-ACRIN Cancer Research Group | Principal Investigator |
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| Chest Computed Tomography | Procedure | Undergo chest CT |
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| Chest Radiography | Procedure | Undergo CXR |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| 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 |
| Up to 5 years of imaging protocol |
| ID | Term |
|---|---|
| D018234 | Sarcoma, Alveolar Soft Part |
| D006394 | Hemangiosarcoma |
| D018227 | Sarcoma, Clear Cell |
| D008080 | Liposarcoma |
| C563195 | Chondrosarcoma, Extraskeletal Myxoid |
| D005354 | Fibrosarcoma |
| D018223 | Dermatofibrosarcoma |
| D007890 | Leiomyosarcoma |
| D018319 | Neurofibrosarcoma |
| D012509 | Sarcoma |
| D013584 | Sarcoma, Synovial |
| D051677 | Histiocytoma, Malignant Fibrous |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018205 | Neoplasms, Adipose Tissue |
| D018218 | Neoplasms, Fibrous Tissue |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D010524 | Peripheral Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D051642 | Histiocytoma |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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