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Evaluation of Chest CT Versus Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma

ConditionsAdult Pleomorphic RhabdomyosarcomaAJCC Grade 2 SarcomaAJCC Grade 3 SarcomaAlveolar Soft Part SarcomaAngiosarcomaClear Cell Sarcoma of Soft TissueDedifferentiated LiposarcomaExtraskeletal Ewing SarcomaExtraskeletal Myxoid ChondrosarcomaFibrosarcomaFibrosarcomatous Dermatofibrosarcoma ProtuberansLeiomyosarcomaMalignant Peripheral Nerve Sheath TumorMyxofibrosarcomaPleomorphic LiposarcomaRound Cell Sarcoma With EWSR1-non-ETS FusionSarcomaSoft Tissue SarcomaSoft Tissue Sarcoma of the Trunk and ExtremitiesSpindle Cell SarcomaStage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Synovial SarcomaUndifferentiated Pleomorphic Sarcoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-85
SponsorECOG-ACRIN Cancer Research Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Patients with the following histiotypes are eligible: dedifferentiated liposarcoma, pleomorphic liposarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, myxofibrosarcoma, fibrosarcomatous dermatofibrosarcoma protuberant variant, spindle cell sarcomas, pleomorphic sarcoma, fibrosarcoma,extra-skeletal myxoid chrondrosarcoma, extraskeletal Ewing and Ewing-like sarcoma, sarcoma not otherwise specified (NOS), or other grade 2 or grade 3 sarcomas not further classified

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Undergo biopsy

  • Chest Computed Tomography

    Procedure/Surgery

    Undergo chest CT

  • Chest Radiography

    Procedure/Surgery

    Undergo CXR

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

1,582 Participants
are divided into 2 treatment groups
Group A: Arm A (CXR)Experimental treatment 5 interventions
Group B: Arm B (CT)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ECOG-ACRIN Cancer Research Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: