Adult Pleomorphic RhabdomyosarcomaNCT06526897
Evaluation of Chest CT Versus Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma
A study testing Biopsy, Chest Computed Tomography and Chest Radiography in people with Adult Pleomorphic Rhabdomyosarcoma and AJCC Grade 2 Sarcoma, run by ECOG-ACRIN Cancer Research Group.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 85 years
- Conditions the study is for
- Adult Pleomorphic Rhabdomyosarcoma, AJCC Grade 2 Sarcoma, AJCC Grade 3 Sarcoma
- What is being tested?
- Biopsy, Chest Computed Tomography and Chest Radiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,582 participants
- Where
- No sites listed yet
- Study dates
- 28 Jan 2025to 1 Nov 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 22Show fewer
- 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
Who cannot join
None listed.
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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):
- 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
- Being tested
- Biopsy, Chest Computed Tomography, Chest Radiography, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Sarcoma, Alveolar Soft Part, Hemangiosarcoma, Sarcoma, Clear Cell, Liposarcoma, Chondrosarcoma, Extraskeletal Myxoid, Fibrosarcoma, Dermatofibrosarcoma, Leiomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo biopsy
Chest Computed TomographyProcedure or surgery
Also called Chest CT, Computed Tomography of the Chest
Undergo chest CT
Chest RadiographyProcedure or surgery
Also called Chest X-ray
Undergo CXR
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Biopsy; Procedure: Chest Computed Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 5 years
Secondary outcomes (11)
Lung disease-free survival
Lung disease-free survival is defined as time from randomization to time of distant lung recurrence. New invasive primary cancer or death from any cause will be censored At each follow-up surveillance examination, data will be collected on symptoms, lung imaging results, and any additional examinations or procedures performed for suspected recurrence. Histopathologically-confirmed recurrences and deaths will be reported at the time of the event.
Measured: up to 5 years
Overall survival (OS) in the pediatric and adolescent and young adult subpopulations
Overall Survival will be evaluated across arms in the pediatric and adolescent and young adult subpopulations Survival will be evaluated at least annually from randomization to death or up to 5 years .
Measured: up to 5 years
Lung disease-free survival in the pediatric and adolescent and young adult subpopulations
Lung disease-free survival is defined as time from randomization to time of distant lung recurrence in the pediatric and adolescent and young adult subpopulations. New invasive primary cancer or death from any cause will be censored At each follow-up surveillance examination, data will be collected on symptoms, lung imaging results, and any additional examinations or procedures performed for suspected recurrence. Histopathologically-confirmed recurrences and deaths will be reported at the time of the event.
Measured: up to 5 years
Overall Survival (OS) based on specific histiotypes
Will assess assess overall survival difference between arms based on specific histiotypes in subgroup analysis.
Measured: Up to 5 years of imaging protocol
Fear of cancer as measured by a modified Psychological Consequences Questionnaire (PCQ):
Fear of cancer associated with care received among those assigned to the CT arm compared to the CXR arm Will be measured using a Modified PCQ Response levels are rated on a four-point Likert scale from 0 (not at all) to 3 (quite a lot of the time). .
The sum of scores results in a total fear score between 0 and 36. Higher scores indicate more psychological dysfunction.
Measured: baseline and every 6 month up to 5 years
PROMIS Anxiety Score
Anxiety will be measured by anxiety associated with care received among those assigned to the CT arm compared to the CXR arm. The 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety, or parent proxy version for those under 18 years of age, will be collected at baseline and every 6 months, up to 5 years during the relevant clinic visit. Anxiety will be modeled as the continuous outcome in the regression models.
Each item on the PROMIS Anxiety measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
Measured: baseline and every 6 month up to 5 years
PROMIS Global-10, Global Health Overall Quality of Life
Overall quality of life (OQOL) will be assessed among those assigned to the CT arm compared to the CXR arm. The PROMIS 10 adult, or parent proxy version for those under 18 years of age, will be collected at baseline and every 6 months, up to 5 years. OQOL will be modeled as the continuous outcome in the regression models.
PROMIS Global-10 is rated on a 5-point (as well as a single 11-point) rating scale. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Measured: baseline and every 6 month up to 5 years
Financial toxicity from the Comprehensive Score for Financial Toxicity (COST)
Financial toxicity is defined as the rating given to a single item from the COST measure "My illness has been a financial hardship to my family and me". The rating is on a 5-point scale (0=Not at All 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very Much) Lower scores indicate greater financial toxicity, while higher scores indicate better financial well-being.
Measured: baseline and every 6 month up to 5 years
Medical Expenditures Panel Surveys Reduction in material resources
Medical Expenditures Panel Surveys will be used to measure reduction in material resources associated with care received among those assigned to the CT arm compared to the CXR arm.
Reduction in material resources is a binary (Yes/No) outcome if any of the following responses is true:
participant has taken on debt, sold a home, or declared bankruptcy;
Measured: baseline and every 6 month up to 5 years
Care non-adherence
Care non-adherence will be measured by care non-adherence associated with care received among those assigned to the CT arm compared to the CXR arm. Care non-adherence is defined as any positive response to the care non-adherence questions:
Did you forego or reduce medication doses due to to financial concerns? Did you forego tests or clinic visits due to financial concerns?
Measured: baseline and every 6 month up to 5 years
Patient-reported out-of-pocket and indirect costs of care
Will be measured by patient-reported out-of-pocket and indirect costs of care associated with care received among those assigned to the CT arm compared to the CXR arm. Patients were asked to estimate their out-of-pocket costs at the time of the clinic visit.
in addition to costs out-of-pocket costs for clinic visits, medication, and co-pays, indirect costs will include lost wages, care-giver substitutes, and transportation costs
Measured: baseline and every 6 month up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start28 Jan 2025 (estimated)
- Primary completion1 Nov 2032 (estimated)
- Study completion1 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Pleomorphic RhabdomyosarcomaStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,582 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kenneth Cardona, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526897
- Sponsor's protocol ID
- EA7201
- Other IDs
- NCI-2023-06179, EA7201, ECOG-ACRIN-EA7201, EA7201, UG1CA189828
- Status last verified
- Jul 2024
- First submitted
- 10 Oct 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06526897
- Acronym / sponsor ID
- EA7201
- Conditions
- Adult Pleomorphic Rhabdomyosarcoma, AJCC Grade 2 Sarcoma, AJCC Grade 3 Sarcoma, Alveolar Soft Part Sarcoma, Angiosarcoma, Clear Cell Sarcoma of Soft Tissue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,582 participants (estimated)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Jan 2025 (estimated)
- Primary completion
- 1 Nov 2032 (estimated)
- Study completion
- 1 Nov 2032 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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):
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (CXR) | Experimental | Procedure: Biopsy, Procedure: Chest Computed Tomography, Procedure: Chest Radiography, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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 (CT) | Experimental | Procedure: Biopsy, Procedure: Chest Computed Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 1 year to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- 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)
- Patient must have a tumor size ≥ 5 cm
- Patient must have had a R0 or R1 oncologic resection on final pathologic report
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyAlso: BIOPSY_TYPE, BxUndergo biopsy | Procedure or surgery | Arm A (CXR), Arm B (CT) |
| Chest Computed TomographyAlso: Chest CT, Computed Tomography of the ChestUndergo chest CT | Procedure or surgery | Arm A (CXR), Arm B (CT) |
| Chest RadiographyAlso: Chest X-rayUndergo CXR | Procedure or surgery | Arm A (CXR) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm A (CXR), Arm B (CT) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (CXR), Arm B (CT) |
Primary outcome
Overall survival (OS)
Time frame: up to 5 years
Overall Survival will be evaluated across arms. Survival will be evaluated at least annually from randomization to death or up to 5 years.
11 secondary outcomes
Lung disease-free survival
Time frame: up to 5 years
Overall survival (OS) in the pediatric and adolescent and young adult subpopulations
Time frame: up to 5 years
Lung disease-free survival in the pediatric and adolescent and young adult subpopulations
Time frame: up to 5 years
Overall Survival (OS) based on specific histiotypes
Time frame: Up to 5 years of imaging protocol
Fear of cancer as measured by a modified Psychological Consequences Questionnaire (PCQ):
Time frame: baseline and every 6 month up to 5 years
PROMIS Anxiety Score
Time frame: baseline and every 6 month up to 5 years
PROMIS Global-10, Global Health Overall Quality of Life
Time frame: baseline and every 6 month up to 5 years
Financial toxicity from the Comprehensive Score for Financial Toxicity (COST)
Time frame: baseline and every 6 month up to 5 years
Medical Expenditures Panel Surveys Reduction in material resources
Time frame: baseline and every 6 month up to 5 years
Care non-adherence
Time frame: baseline and every 6 month up to 5 years
Patient-reported out-of-pocket and indirect costs of care
Time frame: baseline and every 6 month up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenneth Cardona principal investigator
ECOG-ACRIN Cancer Research Group
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy, Chest Computed Tomography and Chest Radiography in people with Adult Pleomorphic Rhabdomyosarcoma and AJCC Grade 2 Sarcoma, run by ECOG-ACRIN Cancer Research Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.