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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different follow-up care schedules after surgery affect anxiety in individuals with stage II-III soft tissue sarcoma, a cancer affecting tissues like muscles and fat. It compares two approaches: frequent check-ups every three months and less frequent visits every six months. The goal is to understand how the frequency of follow-up visits impacts patients' fear of cancer recurrence and overall well-being. Individuals who completed cancer treatments in the last 8-14 weeks and are willing to participate in surveys for two years may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the effectiveness of the follow-up care schedules in an initial, smaller group.

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 prior data suggests that this follow-up protocol is safe for patients with soft tissue sarcoma?

Research has shown that both frequent and less frequent check-ups after surgery for soft tissue sarcoma are generally safe for patients. These check-ups typically involve regular scans, such as CT scans or chest X-rays, to monitor for cancer recurrence.

The scans used in these follow-ups are standard, and most patients tolerate them well. No major side effects have been directly linked to the frequency of these scans.

Studies have not found that more frequent scans improve patient survival. This does not imply they are unsafe; it simply raises questions about their impact on longevity.

Less frequent check-ups may reduce patient anxiety by decreasing hospital visits and scans. This approach remains safe, using the same types of scans but less often.

Overall, both follow-up types are safe. The primary difference lies in their frequency, which can influence a patient’s anxiety and daily life more than their physical health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it investigates two different post-operative surveillance strategies for patients with soft tissue sarcoma. Unlike the standard approach, which typically involves regular but not necessarily intense follow-ups, this trial compares limited surveillance with intense surveillance. The intense follow-up involves more frequent imaging every 3 months, potentially allowing for earlier detection of recurrence, while the limited approach uses less frequent imaging every 6 months, which might reduce patient burden and healthcare costs. By evaluating these approaches, researchers hope to determine the most effective balance between monitoring recurrence and maintaining patient quality of life.

What evidence suggests that this trial's follow-up methods could be effective for reducing anxiety in soft tissue sarcoma patients?

This trial will compare different post-operative surveillance intensities for soft tissue sarcoma. Research has shown that closely monitoring patients with frequent imaging tests after soft tissue sarcoma surgery does not significantly improve survival chances. One study found that check-ups every three months were no better than those every six months. In fact, more frequent follow-ups offered no clear survival benefits compared to less frequent ones. Evidence also suggests that longer gaps between check-ups do not delay treatment if the cancer returns. Overall, both frequent and less frequent follow-up methods seem to provide similar results in terms of survival and detecting cancer recurrence. ^{1 2 6 7 8}

Who Is on the Research Team?

Christina L Roland, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3971232/

Does Intensity of Surveillance Affect Survival After Surgery for ...

This trial could not conclusively demonstrate noninferiority in OS for a 6-monthly interval of followup visits against 3-monthly visits.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0748798321000512

The impact of postoperative radiological surveillance ...

This study did not find a benefit for high-intensity radiological surveillance and overall survival in patients undergoing primary resection.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10527323/

Follow-Up after Curative Surgical Treatment of Soft-Tissue ...

The results show that only 24% of patients received the advised three follow-up visits in the first year after surgery.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05827458

An Adequate Cost Effective Follow Up Protocol For Bone ...

After treatment of the primary tumor, 40 % to 60% of the patients will develop local or distant recurrent disease. The ultimate determinant of ...

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ajronline.org

ajronline.org/doi/10.2214/AJR.22.28865

Usefulness of MRI-Based Local Surveillance After Surgical ...

MRI-based surveillance after surgical treatment of musculoskeletal STS is useful to detect clinically occult LRs and could improve patient outcomes.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03944798

NCT03944798 | Surveillance AFter Extremity Tumor surgerY

Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence.

7.

mdpi.com

mdpi.com/1718-7729/30/3/211

Surveillance Post Surgery for Retroperitoneal Soft Tissue ...

The available observational retrospective data analysis has failed to demonstrate that high-intensity radiological surveillance improves the overall survival ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0748798323007230

Clinician survey of current global practice for sarcoma ...

This clinician survey aims to capture a global, contemporary snapshot of international guidelines used to inform sarcoma surveillance following resection of ...