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

Launched by ECOG-ACRIN CANCER RESEARCH GROUP · Jul 24, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating which imaging test is better for monitoring the lungs after surgery for high-risk soft tissue sarcoma, a type of cancer. Researchers want to compare chest computed tomography (CT) scans to chest X-rays to see which method is more effective at detecting cancer that may have spread to the lungs. Even after successful surgery, some patients can develop lung metastases, so regular monitoring is important. The trial aims to clarify the best approach for lung surveillance, as current guidelines recommend either CT or X-ray every few months for the first few years after surgery.

To be eligible for this trial, participants should be between 1 and 85 years old and have undergone a specific type of surgery for stage III high-risk sarcoma that is at least 5 cm in size. They should also have had a recent chest CT that didn't show concerning findings. Participants can expect to be randomly assigned to receive either a CT scan or a chest X-ray at regular intervals for monitoring. It’s important to note that pregnant individuals are not eligible due to potential risks from the imaging tests. The findings from this study could help improve how patients are monitored after surgery for this type of cancer.

Gender

ALL

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