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

NCT06526897 | Not Yet Recruiting DMC

• 4 other identifiers: EA7201NCI-2023-06179ECOG-ACRIN-EA7201UG1CA189828
• Study Type: interventional
• Target: 1,582
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

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.

  up to 5 years

Secondary Outcomes (11)

• Lung disease-free survival

  up to 5 years

• Overall survival (OS) in the pediatric and adolescent and young adult subpopulations

  up to 5 years

• Lung disease-free survival in the pediatric and adolescent and young adult subpopulations

  up to 5 years

• Overall Survival (OS) based on specific histiotypes

  Up to 5 years of imaging protocol

• Fear of cancer as measured by a modified Psychological Consequences Questionnaire (PCQ):

  baseline and every 6 month up to 5 years

Other Outcomes (1)

• Radiomic features of pulmonary nodules

  Up to 5 years of imaging protocol

Study Arms (2)

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.

Procedure: Biopsy; Procedure: Chest Computed Tomography; Procedure: Chest Radiography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

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.

Procedure: Biopsy; Procedure: Chest Computed Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

Arm A (CXR); Arm B (CT)

Chest Computed Tomography PROCEDURE

Undergo chest CT

Also known as: Chest CT, Computed Tomography of the Chest

Arm A (CXR); Arm B (CT)

Chest Radiography PROCEDURE

Undergo CXR

Also known as: Chest X-ray

Arm A (CXR)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (CXR); Arm B (CT)

Questionnaire Administration OTHER

Ancillary studies

Arm A (CXR); Arm B (CT)

Eligibility Criteria

• Age: 1 Year - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients with a high-risk histiotype that is typically not graded, including adult pleomorphic rhabdomyosarcoma, synovial sarcoma, angiosarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma, epithelioid sarcoma, or clear cell sarcoma are eligible
• 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
• All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy
• A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• 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

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Sarcoma, Alveolar Soft Part; Hemangiosarcoma; Sarcoma, Clear Cell; Liposarcoma; Chondrosarcoma, Extraskeletal Myxoid; Fibrosarcoma; Dermatofibrosarcoma; Leiomyosarcoma; Neurofibrosarcoma; Sarcoma; Sarcoma, Synovial; Histiocytoma, Malignant Fibrous

Interventions

Biopsy; X-Rays

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Neoplasms, Connective Tissue; Neoplasms, Adipose Tissue; Neoplasms, Fibrous Tissue; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Histiocytoma

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Kenneth Cardona

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: July 30, 2024
• Study Start: January 28, 2025
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): November 1, 2032
• Last Updated: July 30, 2024

Record last verified: 2024-07