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

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.

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

Undergo biopsy

PROCEDURE

Chest Computed Tomography

Undergo chest CT

PROCEDURE

Chest Radiography

Undergo CXR

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• ECOG-ACRIN Cancer Research Group

  lead NETWORK

Principal Investigators

• Kenneth Cardona · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-28

Primary Completion

2032-11-01

Completion

2032-11-01