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Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Phase 2NCT04751409

Evaluating the Impact of Limited Compared With Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Stage II-III Soft Tissue Sarcoma of the Trunk and Extremities

A Phase 2 study testing Chest Radiography, Computed Tomography and Follow-Up in people with Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II trial studies how anxiety is affected by 2 types of follow-up after surgery, limited follow-up and intense follow-up, in patients with stage II-III soft tissue sarcoma of the trunk and extremities. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Chest Radiography, Computed Tomography and Follow-Up
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
227 participants
Where
1 siteUnited States
Study dates
28 Dec 2020to 31 Dec 2027
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Documented metastatic disease at the time of enrollment
  • Non-English-speaking patients
  • Pregnant women will be included in this clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christina L Roland, MD contact

713-792-6940

clroland@mdanderson.org

United States1 site, 1 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Christina L. Roland, 713-792-6940, clroland@mdanderson.org

    Christina L. Roland

    Recruiting

Other trials in United States

About this study

Official title: Evaluating the Impact of Limited vs. Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Soft Tissue Sarcoma

This phase II trial studies how anxiety is affected by 2 types of follow-up after surgery, limited follow-up and intense follow-up, in patients with stage II-III soft tissue sarcoma of the trunk and extremities. In cancer survivors, the fear of cancer coming back (recurring) is common and may persist long after the end of treatment. It may also be exacerbated by return visits for imaging (surveillance). The purpose of this study is to determine how patients' anxiety and other cancer-related outcomes are affected by how often surveillance is done.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate whether a risk-based limited follow-up surveillance is associated with reduced patient anxiety compared to risk-based intense surveillance.

SECONDARY OBJECTIVE:

  1. To evaluate the impact of reduced surveillance in low-risk patients on overall survival, time to local or distant recurrence, anxiety at early and late time-points, out of pocket costs, and number of missed or extra clinic visits, compared to the risk-based intense follow-up in both low-risk and high-risk patients.

OUTLINE: Patients are assigned to 1 of 2 groups based on risk status.

GROUP 1 (LOW RISK): Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with computed tomography (CT)-chest and imaging of the primary site.

ARM II: Patients undergo limited follow-up every 6 months for 2 years consisting of restaging with either CT-chest or chest x-ray (CXR) and imaging of the primary site.

GROUP 2 (HIGH RISK): Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.

Being tested
Chest Radiography, Computed Tomography, Follow-Up, Imaging Technique, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chest RadiographyProcedure or surgery

    Also called Chest X-ray

    Undergo CXR

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography

    Undergo CT-chest

  • Follow-UpProcedure or surgery

    Also called Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up

    Undergo intense follow-up

  • Follow-UpProcedure or surgery

    Also called Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up

    Undergo limited follow-up

  • Imaging TechniqueProcedure or surgery

    Also called Diagnostic Imaging Technique, Imaging, imaging procedure, Imaging Procedures

    Undergo imaging

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04751409
Study groupRoleWhat they receive
Group 1, Arm I (intense follow up)ExperimentalPatients undergo intense follow-up every 3 months for 2 years consisting of restaging with CT-chest and imaging of the primary site.
Receives: Procedure: Computed Tomography; Procedure: Follow-Up; Procedure: Imaging Technique; Other: Questionnaire Administration
Group 1, Arm II (limited follow-up)ExperimentalPatients undergo limited follow-up every 6 months for 2 years consisting of restaging with either CT-chest or CXR and imaging of the primary site.
Receives: Procedure: Chest Radiography; Procedure: Computed Tomography; Procedure: Follow-Up; Procedure: Imaging Technique; Other: Questionnaire Administration
Group 2 (intense follow up)ExperimentalPatients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.
Receives: Procedure: Computed Tomography; Procedure: Follow-Up; Procedure: Imaging Technique; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total score for Fear of Cancer Recurrence Inventory - Short Form

    Will be calculated as the area under the curve by obtaining patient-reported outcomes at 4 separate time points and then graphically calculating and comparing the area under the curve for each patient. The mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form will be estimated along with a 95% confidence interval within each study group.

    Measured: Baseline to 12 months after surgery

  2. Mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form

    Will be estimated along with a 95% confidence interval within each study group.

    Measured: Up to 12 months after surgery

Secondary outcomes (8)

  1. Change in fear of recurrence

    Will be assessed by the Fear of Cancer Recurrence Inventory - Short Form via linear mixed models over time and to compare changes of these assessments over time between the two low-risk groups adjusting for important covariates such age, gender and other patient prognostic factors.

    Measured: Baseline up to 24 months post-resection

  2. Change in distress

    Will be assessed by the Impact of Events scale via linear mixed models over time and to compare changes of these assessments over time between the two low-risk groups adjusting for important covariates such age, gender and other patient prognostic factors.

    Measured: Baseline up to 24 months post-resection

  3. Change in anxiety and depression

    Will be assessed by the Hospital Anxiety and Depression Scale via linear mixed models over time and to compare changes of these assessments over time between the two low-risk groups adjusting for important covariates such age, gender and other patient prognostic factors.

    Measured: Baseline up to 24 months post-resection

  4. Change in out-of-pocket costs

    Will be assessed by the Cost Survey via linear mixed models over time and to compare changes of these assessments over time between the two low-risk groups adjusting for important covariates such age, gender and other patient prognostic factors.

    Measured: Baseline up to 24 months post-resection

  5. Time to local recurrence

    Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups.

    Measured: From time of surgery to local recurrence as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause, whichever occurs first, assessed up to 2 years

  6. Time to distant metastasis

    Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups.

    Measured: From time of surgery to distant metastasis as defined by RECIST or death from any cause, whichever occurs first, assessed up to 2 years

  7. Overall survival

    Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups.

    Measured: From time of surgery to death, assessed up to 2 years

  8. Number of missed or extra clinic visits

    The analysis of number of missed or extra clinic visits will be descriptive in nature.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2021
  2. Study start28 Dec 2020
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
227 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04751409
Sponsor's protocol ID
2020-0854
Other IDs
NCI-2021-00436, 2020-0854
Status last verified
Sep 2026
First submitted
8 Feb 2021
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chest Radiography, Computed Tomography and Follow-Up in people with Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.

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 0 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Christina L Roland, MD (713-792-6940, clroland@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total score for Fear of Cancer Recurrence Inventory - Short Form (time frame: Baseline to 12 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04751409.

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 14 Sep 2026.

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