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

NCT ID: NCT06526897

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1582 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-28
• Study Completion Date: 2032-11-01

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.

Detailed Description

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Biopsy

Intervention Type: PROCEDURE

Undergo biopsy

Chest Computed Tomography

Intervention Type: PROCEDURE

Undergo chest CT

Chest Radiography

Intervention Type: PROCEDURE

Undergo CXR

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

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.

Group Type: EXPERIMENTAL

Biopsy

Intervention Type: PROCEDURE

Undergo biopsy

Chest Computed Tomography

Intervention Type: PROCEDURE

Undergo chest CT

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Biopsy

Undergo biopsy

Intervention Type: PROCEDURE

Chest Computed Tomography

Undergo chest CT

Intervention Type: PROCEDURE

Chest Radiography

Undergo CXR

Intervention Type: PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

BIOPSY_TYPE; Bx; Chest CT; Computed Tomography of the Chest; Chest X-ray; Quality of Life Assessment

Eligibility Criteria

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)

• 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
• 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

• NOTE: Sites cannot translate the associated QOL forms

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Cardona

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Other Identifiers

NCI-2023-06179

Identifier Type: REGISTRY

Identifier Source: secondary_id

EA7201

Identifier Type: OTHER

Identifier Source: secondary_id

ECOG-ACRIN-EA7201

Identifier Type: OTHER

Identifier Source: secondary_id

EA7201

Identifier Type: OTHER

Identifier Source: secondary_id

UG1CA189828

Identifier Type: NIH

Identifier Source: secondary_id

View Link

EA7201

Identifier Type: -

Identifier Source: org_study_id