Post-Operative Surveillance Intensity for Soft Tissue Sarcoma

Overseen By Christina L Roland, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Metastatic disease, Non-English-speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

227 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Limited Compared With Intense Post-Operative Surveillance for soft tissue sarcoma?

The research suggests that while intense imaging surveillance can detect issues earlier than patient symptoms, it often finds unclear results that may not be significant. This implies that intense surveillance might not always lead to better outcomes compared to limited surveillance. ^{1 2 3 4 5}

Is post-operative surveillance for soft tissue sarcoma generally safe for humans?

The research highlights that adverse events (unexpected medical problems) can occur after surgeries, including those for soft tissue reconstruction, with about 4% of patients experiencing such events. This suggests that while post-operative surveillance is important, there are risks involved, and safety measures should be in place to monitor and address any issues that arise. ^{6 7 8 9 10}

How does the post-operative surveillance treatment for soft tissue sarcoma differ from other treatments?

This treatment is unique because it compares limited versus intense post-operative surveillance to see if more frequent monitoring improves survival after surgery for soft tissue sarcoma. Unlike standard treatments, which vary widely and lack consensus, this study aims to determine the optimal frequency of follow-up to detect recurrences or complications early. ^{1 2 4 11 12}

Research Team

Christina L Roland, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults over 18 who have had surgery for stage II-III soft tissue sarcoma of the trunk and extremities. They must be willing to complete surveys for two years and should have finished their cancer therapy, including chemotherapy, radiation, or surgery, within 8-14 weeks before joining the study.

Inclusion Criteria

I finished my sarcoma treatment 8-14 weeks ago.

Willingness to complete surveys x 2 years

Pregnant women will be included in this clinical trial.

Exclusion Criteria

I do not speak English.

My cancer has spread to other parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-Surgery Follow-up

Participants undergo either intense or limited follow-up based on risk status, with imaging and restaging

24 months

Every 3 months (intense) or every 6 months (limited)

Follow-up

Participants are monitored for anxiety, survival, and recurrence outcomes

24 months

Treatment Details

Interventions

• Limited Compared With Intense Post-Operative Surveillance

Trial Overview The trial is examining how different follow-up schedules after surgery affect patient anxiety and other outcomes. One group will receive limited surveillance with chest radiography while another will undergo intense surveillance using computed tomography (CT) scans.

Participant Groups

Group I: Group 2 (intense follow up) Experimental Treatment 4 Interventions

Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.

Group II: Group 1, Arm II (limited follow-up) Experimental Treatment 5 Interventions

Patients 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.

Group III: Group 1, Arm I (intense follow up) Experimental Treatment 4 Interventions

Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with CT-chest and imaging of the primary site.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

A less intensive follow-up protocol (6-monthly visits) for patients with extremity sarcomas did not show a significant decrease in overall survival (OS) compared to more frequent (3-monthly) visits, indicating that less frequent monitoring may be sufficient for patient outcomes.

Imaging with chest radiographs was as effective as CT scans in detecting pulmonary metastasis, suggesting that less expensive imaging methods can be used without negatively impacting patient survival or disease-free survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does intensity of surveillance affect survival after surgery for sarcomas? Results of a randomized noninferiority trial. Puri, A., Gulia, A., Hawaldar, R., et al.[2022]

Out of 409,991 patients who underwent soft tissue reconstructive procedures from 2005 to 2010, 4.06% experienced adverse events (AEs), indicating that while AEs are not uncommon, the overall rates are lower compared to other surgical disciplines.

Certain patient characteristics, such as older age, male gender, nonwhite ethnicity, and reliance on public insurance, were associated with higher rates of AEs, highlighting the need for targeted quality improvement efforts in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in plastic surgery: identifying areas for quality improvement efforts. Hernandez-Boussard, T., McDonald, KM., Rhoads, KF., et al.[2022]

The Spinal Tumor Surgery Risk Index (STSRI) was developed using data from 14,982 surgeries and successfully predicted major adverse events (AEs) and death within 30 days post-surgery, with an area under the curve of 0.86 for internal validation.

The STSRI outperformed existing risk assessment tools, demonstrating a sensitivity of around 80% and specificity of approximately 74%, making it a reliable tool for preoperative risk estimation in spinal tumor surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and External Validation of the Spinal Tumor Surgery Risk Index. Alomari, S., Theodore, J., Ahmed, AK., et al.[2023]

A new surveillance model was developed to identify adverse events (AEs) in outpatient surgeries, using six electronic triggers and analyzing data from over 744,000 surgeries, which showed a 20% rate of AEs in reviewed cases.

The model demonstrated strong predictive ability, with an 85% positive predictive value for surgeries with a high probability of AEs, indicating it can effectively help in monitoring and improving patient safety in outpatient surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an Adverse Event Surveillance Model for Outpatient Surgery in the Veterans Health Administration. Mull, HJ., Itani, KMF., Pizer, SD., et al.[2021]

Standardized data collection of postoperative adverse events in thoracic surgery can significantly enhance patient care by documenting and informing practices to reduce complications.

Engaging surgeons in audit and feedback based on this data can lead to consensus recommendations that improve patient outcomes following high-risk surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized Postoperative Adverse Event Data Collection to Document, Inform, and Improve Patient Care. Shamji, FM., Gingrich, M., Anstee, C., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Image intensive soft tissue sarcoma surveillance uncovers pathology earlier than patient complaints but with frequent initially indeterminate lesions. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Does intensity of surveillance affect survival after surgery for sarcomas? Results of a randomized noninferiority trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

How surgeon age affects surveillance strategies for extremity soft tissue sarcoma patients after potentially curative treatment. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Local recurrence of soft-tissue sarcoma: issues in imaging surveillance strategy. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The follow-up of adult soft-tissue sarcomas. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Patient safety in plastic surgery: identifying areas for quality improvement efforts. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Development and External Validation of the Spinal Tumor Surgery Risk Index. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Development of an Adverse Event Surveillance Model for Outpatient Surgery in the Veterans Health Administration. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

Postoperative serious adverse events in a teaching hospital: a prospective study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Standardized Postoperative Adverse Event Data Collection to Document, Inform, and Improve Patient Care. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Follow-up after initial surgical treatment of soft tissue sarcomas in the extremities and trunk wall. [2022]

12. Greece pubmed.ncbi.nlm.nih.gov

Patient surveillance after treatment for soft-tissue sarcoma. [2015]