Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526897
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2023-10-10
Brief Title:
Evaluation of Chest CT Versus Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Randomized Controlled Trial of Chest CT vs Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None