Enhanced Recovery After Surgery for Sarcoma

Overseen By Vanderbilt-Ingram Service for Timely Access

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Joshua Lawrenz

Disqualifiers: Non-operative treatment, Non-English speaking

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a special surgery recovery plan, Enhanced Recovery After Surgery (ERAS), for individuals undergoing surgery to remove sarcoma in their arms or legs. It compares two approaches: a new method using less narcotic pain medication and the traditional method that includes narcotics. The goal is to determine if the new method improves patient recovery. This trial may suit adults undergoing surgery for suspected sarcoma in their limbs at Vanderbilt University Medical Center. As an unphased trial, it provides a unique opportunity to contribute to innovative recovery strategies that could enhance future surgical outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Enhanced Recovery After Surgery protocol is safe for patients undergoing surgical treatment for extremity sarcoma?

Research has shown that the Enhanced Recovery After Surgery (ERAS) protocol is safe and beneficial for patients. Studies indicate that it can reduce the risk of postoperative complications. For instance, one study found that patients who followed the ERAS plan experienced fewer issues and had shorter hospital stays. Another study demonstrated that adherence to the ERAS plan results in fewer complications.

While the research does not specifically focus on safety data for ERAS, the evidence suggests it is generally well-tolerated by patients. Most individuals can undergo the treatment without serious problems. Overall, ERAS aims to make recovery smoother and faster without adding risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Recovery After Surgery (ERAS) approach for sarcoma because it emphasizes a non-narcotic, multimodal pain management strategy. Unlike conventional methods that often rely heavily on narcotics, ERAS aims to minimize narcotic use, potentially reducing the risk of addiction and enhancing recovery times. By using a combination of non-narcotic medications and techniques, ERAS could lead to faster recovery, fewer complications, and an overall better patient experience after surgery.

What evidence suggests that the Enhanced Recovery After Surgery protocol is effective for sarcoma surgery?

Research has shown that Enhanced Recovery After Surgery (ERAS) programs help patients recover more quickly after surgery. In this trial, participants will join either the ERAS arm or the Non-ERAS (Conventional) arm. For those with soft tissue sarcoma, ERAS is linked to fewer health issues post-surgery and shorter hospital stays. Another study highlighted that ERAS protocols can reduce the risk of complications, making surgery safer. Specifically, patients in that study experienced faster recovery times and shorter hospital stays with ERAS. This approach employs various pain management methods that minimize the use of strong painkillers, promoting a smoother recovery process. ^{1 2 4 6 7}

Who Is on the Research Team?

Joshua M Lawrenz, MD

Principal Investigator

Vanderbilt Medical Center

Are You a Good Fit for This Trial?

This trial is for adult patients over 17 years old at Vanderbilt University Medical Center who are about to have surgery for suspected sarcoma in an arm or leg. It's open to those who've never taken opioids and those who currently use them. Non-English speakers and patients not having surgery are excluded.

Inclusion Criteria

My opioid use before surgery varies.

I had surgery at Vanderbilt for a suspected sarcoma in my arm or leg.

I am older than 17 years.

Exclusion Criteria

I am being treated without surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Perioperative Treatment

Administration of a perioperative non-narcotic, multimodal pain management pathway

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores, limb function, and clinical outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Recovery After Surgery

Trial Overview The study is testing a program called Enhanced Recovery After Surgery (ERAS) specifically designed for people getting surgical treatment for extremity sarcoma, which affects the limbs. The goal is to see if ERAS improves recovery outcomes after their operations.

How Is the Trial Designed?

Group I: ERAS Experimental Treatment 1 Intervention

Administration of a perioperative non-narcotic, multimodal pain management pathway.

Group II: Non-ERAS (Conventional) Active Control 1 Intervention

Administration of a conventional perioperative pain management pathway that consists of both narcotic and non-narcotic pain medications.

Enhanced Recovery After Surgery is already approved in European Union, United States, Canada, China for the following indications:

Approved in European Union as ERAS for:

• Colorectal surgery
• Gynecologic surgery
• Orthopedic surgery
• Gastrointestinal surgery

Approved in United States as ERAS for:

• Gynecologic surgery
• Orthopedic surgery
• Gastrointestinal surgery
• Surgical oncology

Approved in Canada as ERAS for:

• General surgery
• Orthopedic surgery
• Gastrointestinal surgery

Approved in China as ERAS for:

• Gastrointestinal surgery
• Orthopedic surgery
• Gynecologic surgery

Who Is Running the Clinical Trial?

Joshua Lawrenz

Lead Sponsor

Trials

1

Recruited

120+

Published Research Related to This Trial

The Soft Tissue and Bone Sarcoma Group has conducted extensive research over 10 years, involving 750 patients in phase III trials and 464 in randomized phase II studies, highlighting their commitment to improving treatment for sarcomas despite their low incidence.

Advancements in surgical techniques for extremity sarcomas have led to better limb preservation while maintaining local control, but challenges remain with systemic metastasis, indicating a need for further research in adjuvant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the clinical trials activity of the Soft Tissue and Bone Sarcoma Group of the European Organization for Research and Treatment of Cancer. Bramwell, VH., Santoro, A., Rouesse, J., et al.[2019]

The ERAS protocol aims to enhance recovery after colorectal cancer surgery and is being tested in a large multicenter trial involving 2200 patients across 28 surgical centers in Piemonte, Italy, to assess its impact on hospital stay length and postoperative outcomes.

The study will compare standard care with the ERAS protocol, monitoring adherence and outcomes like recovery time and patient satisfaction, with a high statistical power of 98% to detect meaningful changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the ERAS (Enhanced Recovery After Surgery) protocol for colorectal cancer surgery in the Piemonte Region with an Audit and Feedback approach: study protocol for a stepped wedge cluster randomised trial: a study of the EASY-NET project. Pagano, E., Pellegrino, L., Rinaldi, F., et al.[2021]

Delayed diagnosis significantly contributes to the poor outcomes for patients with sarcomas, highlighting the need for improved patient pathways and clinical guidelines.

Centralizing care in expert centers is crucial for enhancing diagnosis and treatment, as these centers concentrate multidisciplinary expertise that can lead to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of expert centres in the management of sarcomas--a UK perspective. Benson, C., Judson, I.[2022]

In a study of 918 patients undergoing lower extremity sarcoma surgery, the overall rate of soft tissue complications within 30 days was found to be 5.7%, indicating a relatively low incidence of immediate postoperative issues.

Significant risk factors for these complications included older age, higher body mass index (BMI), and longer operative times, highlighting the importance of patient assessment before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors associated with 30-day complications following lower extremity sarcoma surgery: A national surgical quality improvement project analysis. Hudson, T., Burke, C., Mullner, D., et al.[2022]

The implementation of an Enhanced Recovery After Surgery (ERAS) program for patients with soft tissue sarcoma significantly reduced wound complications, with only 0.9% experiencing wound dehiscence compared to 13.1% in the non-ERAS group, indicating improved surgical outcomes.

Patients in the ERAS program also had a shorter median hospital stay of 5 days compared to 6 days for those not in the program, along with lower rates of postoperative ileus or obstruction, suggesting enhanced recovery and reduced morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced recovery after surgery pathway in patients with soft tissue sarcoma. Lyu, HG., Saadat, LV., Bertagnolli, MM., et al.[2021]

The ERAS protocol implemented in gynecological surgery showed no significant difference in length of stay (LOS) between patients undergoing hysterectomy for malignant (2 days) versus benign (2 days) conditions, indicating its effectiveness for both groups.

Patients with malignant and benign conditions had similar rates of complications, reoperations, and readmissions, suggesting that the ERAS protocol is safe and beneficial for enhancing recovery regardless of the nature of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. Wijk, L., Franzén, K., Ljungqvist, O., et al.[2018]

The implementation of an Enhanced Recovery After Surgery (ERAS) protocol in a small rural hospital for colorectal surgery led to a significant reduction in length of stay (LOS) by approximately 2 days compared to matched controls.

Most patients in the ERAS group adhered to the protocol, demonstrating effective self-care practices post-surgery, which contributed to their quicker recovery and earlier mobilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced recovery after surgery reduces length of stay after colorectal surgery in a small rural hospital in Ontario. Roldan, HA., Brown, AR., Radey, J., et al.[2023]

The introduction of Enhanced Recovery After Surgery (ERAS) protocols in soft-tissue sarcoma (STS) surgery significantly reduced hospital stays from an average of 9 days to 3 days without increasing major complications or readmissions, indicating improved postoperative recovery.

ERAS implementation led to a notable decrease in wound drainage and an increase in wound bandaging, suggesting effective perioperative management, while maintaining similar rates of tumor control and local recurrence compared to standard recovery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The introduction of early patient rehabilitation in surgery of soft tissue sarcoma and its impact on post-operative outcome. Michot, A., Stoeckle, E., Bannel, JD., et al.[2015]

This multicenter, observational study aims to evaluate postoperative complications within 30 days after gastric cancer surgery, assessing the effectiveness of Enhanced Recovery After Surgery (ERAS) protocols, with data collected over a 3-month period.

The study will explore the relationship between adherence to the ERAS protocol and postoperative complications, potentially identifying areas for improvement in surgical recovery practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Outcomes Within an Enhanced Recovery after surgery protocol in gastric surgery for cancer (POWER.4): Study protocol for a prospective, multicentre, observational cohort study. Abad-Motos, A., Ripollés-Melchor, J., Bruna-Esteban, M., et al.[2021]

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]

In a study of 32 patients undergoing flap reconstruction after sarcoma resection, those who had immediate reconstruction experienced significantly fewer overall complications (28%) compared to those with delayed reconstruction (100%).

Delayed reconstruction was associated with a higher rate of hematomas (28.6% vs. 0.0%) and other complications, highlighting the importance of timely surgical intervention and close monitoring for patients undergoing delayed procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of delayed versus immediate reconstruction following lower-extremity sarcoma resection. Zhou, S., Azzi, AJ., Safran, T., et al.[2020]

A study involving 15 sarcoma survivors revealed that returning to work (RTW) is often motivated by a desire to distract from their illness and move on from their treatment experiences.

Participants faced challenges in RTW due to lingering effects of their disease and treatment, as well as peer perceptions, highlighting the need for support from health professionals and employers to ease this transition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of return to work after treatment for extremital soft tissue or bone sarcoma: Between distraction and leaving the disease behind. Zambrano, SC., Kollár, A., Bernhard, J.[2020]

The study reviewed cases of complex sarcoma resections at a large center, involving 11 patients, and found that early complications occurred in 18% and late complications in 36%, indicating a high morbidity associated with these procedures.

Patients with poor preoperative nutritional status were more likely to experience postoperative complications, highlighting the importance of nutritional assessment in surgical planning for sarcoma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GHOST Protocol: Greatest Healing Opportunity for Soft Tissue, a Treatment Paradigm for Complex Sarcoma Reconstruction. Kobraei, EM., Eberlin, KR., Ricci, JA., et al.[2022]

The modified Eilber protocol, a neoadjuvant chemoradiation treatment for extremity soft tissue sarcomas, showed similar local control rates compared to standard adjuvant radiotherapy, with 10% recurrence in the Eilber group versus 15% in the Adjuvant group.

Patients receiving the Eilber protocol experienced significantly lower rates of severe late toxicities (3.4%) compared to those receiving adjuvant radiotherapy (27%), indicating a safer long-term profile for the neoadjuvant approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant chemoradiation (modified Eilber protocol) versus adjuvant radiotherapy in the treatment of extremity soft tissue sarcoma. Lehane, C., Ho, F., Thompson, SR., et al.[2017]

In a study of patients with extremity soft-tissue sarcomas treated at a specialized center, complications were more common in those who underwent secondary flap reconstruction due to inadequate primary wound closure compared to those who had primary flap reconstruction.

The study emphasizes the importance of interdisciplinary collaboration in treating soft-tissue sarcomas and proposes an algorithm for surgical therapy that includes both resection and reconstruction strategies to optimize patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interdisciplinary Surgical Therapy of Extremity Soft-Tissue Sarcomas: A Personalized Resection and Reconstruction Algorithm. Osterloh, J., Ludolph, I., Grützmann, R., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7938834/

Enhanced recovery after surgery pathway in patients with ... An enhanced recovery after surgery (ERAS) programme may improve perioperative outcomes in abdominal surgery. This study reported outcomes of an ...

2. withpower.com withpower.com/trial/phase-sarcoma-11-2020-0010a

Enhanced Recovery After Surgery for Sarcoma Research shows that ERAS programs, which help patients recover faster after surgery, have been effective in reducing hospital stay and improving recovery in ...

3. ons.confex.com ons.confex.com/ons/2023/meetingapp.cgi/Paper/12479

Enhanced Surgical Recovery (ESR) Protocols for Sarcoma ... ESR protocols are shown to decrease the risk of post operative complications to optimize the patient for surgical intervention. There are limited studies for ...

4. wjgnet.com wjgnet.com/2218-4333/full/v16/i10/108419.htm

Surgeons' opinions about enhanced recovery after surgery ... Core Tip: This study explores the development of an enhanced recovery after surgery (ERAS) program tailored to retroperitoneal sarcoma (RPS) ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32618371/

Enhanced recovery after surgery pathway in patients with soft ... Treatment within an ERAS protocol for patients with soft tissue sarcoma was associated with lower morbidity and shorter hospital stay.

6. link.springer.com link.springer.com/article/10.1007/s13193-025-02374-w

Indian Journal of Surgical Oncology The overall compliance rate with ERAS® protocols was 84.5% (81.8% in bone tumour groups and 82.2% in soft tissue groups). A significant ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24003013

Impact of compliance with an enhanced recovery after ... Compliance with an ERAS pathway exceeding 80% was associated with lower complication rates and shorter length of stay without impacting on re-operations or ...