SarcomaNCT04461171
Enhanced Recovery After Surgery in Extremity Sarcoma
A study testing Enhanced Recovery After Surgery in people with Sarcoma, run by Joshua Lawrenz at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the efficacy of implementing the enhanced recovery after surgery (ERAS) pathway in a prospective manner to patients undergoing surgical treatment for extremity sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Enhanced Recovery After Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2020to Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient at Vanderbilt University Medical Center treated with surgical excision of a suspected extremity sarcoma
- Adult patients >17 years of age
- Patients of all preoperative opioid status (naïve or dependent)
Who cannot join
- Patients treated non-operatively
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Vanderbilt-Ingram Service for Timely Access, 800-811-8480, cip@vumc.org
Joshua M Lawrenz, MD
About this study
The purpose of this study is to demonstrate the efficacy of implementing the enhanced recovery after surgery (ERAS) pathway in a prospective manner to patients undergoing surgical treatment for extremity sarcoma.
Read the detailed description
Specifically, the focus of this study will be regarding the administration of a perioperative non-narcotic, multimodal pain management pathway. Primary endpoints collected with be short-term patient reported outcomes (pain scores [PROMIS] and [QoR-15]), limb function scores [MSTS], and key clinical outcomes (hospital length of stay, opioid requirements/prescribing data and perioperative complications).
- Conditions
- Sarcoma
- Being tested
- Enhanced Recovery After Surgery
- Keywords
- Enhanced Recovery After Surgery
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After SurgeryProcedure or surgery
Undergo an enhanced recovery after surgery program
| Study group | Role | What they receive |
|---|---|---|
| ERAS | Experimental | Administration of a perioperative non-narcotic, multimodal pain management pathway. Receives: Procedure: Enhanced Recovery After Surgery |
| Non-ERAS (Conventional) | No intervention | Administration of a conventional perioperative pain management pathway that consists of both narcotic and non-narcotic pain medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Measured by Quality of Recovery questionnaire (QoR-15) scale = 0-10 (0=none of the time and 10 = all of the time)
Measured: 3 months
Pain scores
Measured by Patient-Reported Outcomes Measurement Information System (PROMIS-29 Profile v2.0) Score 1-5 (1 being worst and 5 being best)
Measured: 3 months
Limb function
Measured by Musculoskeletal Tumor Society scoring system (MSTS) scored from 0-5 (5 being best and 0 being worst)
Measured: 3 months
Clinical outcomes - length of hospital stay
Measured by the number of days in the hospital
Measured: 3 months
Clinical outcomes - opioid requirements
Measured by the amount of opioids consumed
Measured: 3 months
Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission)
Measured by the number of perioperative complications reported
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start14 Dec 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Two-group, prospective, consecutively enrolled, comparative non-randomized trial (N = 120) is to determine the feasibility and efficacy of implementing an enhanced recovery after surgery (ERAS) pain management pathway to patients undergoing surgical treatment for an extremity sarcoma.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joshua Lawrenz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua Lawrenz, Vanderbilt-Ingram Cancer Center
- Investigators
- Joshua Lawrenz, MD, Principal investigator, Vanderbilt Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461171
- Sponsor's protocol ID
- VICC SAR 2020
- Status last verified
- Nov 2025
- First submitted
- 10 Jun 2020
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery in Extremity Sarcoma
- ClinicalTrials.gov ID
- NCT04461171
- Acronym / sponsor ID
- VICC SAR 2020
- Conditions
- Sarcoma
- Keywords
- Enhanced Recovery After Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Joshua LawrenzUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jul 2020 (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.
The purpose of this study is to demonstrate the efficacy of implementing the enhanced recovery after surgery (ERAS) pathway in a prospective manner to patients undergoing surgical treatment for extremity sarcoma.
Detailed description
Specifically, the focus of this study will be regarding the administration of a perioperative non-narcotic, multimodal pain management pathway. Primary endpoints collected with be short-term patient reported outcomes (pain scores [PROMIS] and [QoR-15]), limb function scores [MSTS], and key clinical outcomes (hospital length of stay, opioid requirements/prescribing data and perioperative complications).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-group, prospective, consecutively enrolled, comparative non-randomized trial (N = 120) is to determine the feasibility and efficacy of implementing an enhanced recovery after surgery (ERAS) pain management pathway to patients undergoing surgical treatment for an extremity sarcoma.
| Arm | Type | Receives |
|---|---|---|
| ERAS | Experimental | Procedure: Enhanced Recovery After SurgeryAdministration of a perioperative non-narcotic, multimodal pain management pathway. |
| Non-ERAS (Conventional) | No intervention | –Administration of a conventional perioperative pain management pathway that consists of both narcotic and non-narcotic pain medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient at Vanderbilt University Medical Center treated with surgical excision of a suspected extremity sarcoma
- Adult patients >17 years of age
- Patients of all preoperative opioid status (naïve or dependent)
Key exclusion criteria (2 listed)
- Patients treated non-operatively
- Non-English speaking patients
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 |
|---|---|---|
| Enhanced Recovery After SurgeryUndergo an enhanced recovery after surgery program | Procedure or surgery | ERAS |
Primary outcome
Pain scores
Time frame: 3 months
Measured by Quality of Recovery questionnaire (QoR-15) scale = 0-10 (0=none of the time and 10 = all of the time)
Pain scores
Time frame: 3 months
Measured by Patient-Reported Outcomes Measurement Information System (PROMIS-29 Profile v2.0) Score 1-5 (1 being worst and 5 being best)
Limb function
Time frame: 3 months
Measured by Musculoskeletal Tumor Society scoring system (MSTS) scored from 0-5 (5 being best and 0 being worst)
Clinical outcomes - length of hospital stay
Time frame: 3 months
Measured by the number of days in the hospital
Clinical outcomes - opioid requirements
Time frame: 3 months
Measured by the amount of opioids consumed
Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission)
Time frame: 3 months
Measured by the number of perioperative complications reported
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 21 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Joshua Lawrenz, MD principal investigator
Vanderbilt Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery in people with Sarcoma, run by Joshua Lawrenz 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 3 inclusion and 2 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 21 Aug 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.
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 Vanderbilt-Ingram Service for Timely Access (800-811-8480, cip@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: 3 months). The study lists 6 primary outcomes in all. 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 21 Aug 2026.