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

Sponsor
ECOG-ACRIN Cancer Research Group
Study ID
NCT06526897
Status
Not Yet Recruiting

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Conditions

  • AJCC Grade 2 Sarcoma
  • AJCC Grade 3 Sarcoma
  • Adult Pleomorphic Rhabdomyosarcoma
  • 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

Eligibility Criteria

Sex
ALL
Age
1 Year - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsy
  • Chest Computed Tomography — PROCEDURE
    Undergo chest CT
  • Chest Radiography — PROCEDURE
    Undergo CXR
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

First listed
Jul 30, 2024
Start date
Jan 28, 2025
Status verified
Jul 2024
Primary completion
Nov 1, 2032
Completion
Nov 1, 2032

Study Design

Enrollment
1,582 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Arm A (CXR)
    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.
  • Experimental: Arm B (CT)
    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.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: up to 5 years ]

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