TumorsPRSNCT02456389
Perioperative Risk Study
A study testing Preoperative risk stratification, Postoperative risk stratification and Risk-based, escalating levels of care in people with Tumors and Primary Neoplasm, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
The primary objective of this trial is to determine if perioperative risk stratification and risk-based, protocol-driven management leads to a reduction in the rate of death or serious complications compared to standard perioperative management in patients undergoing elective major cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors, Primary Neoplasm, Secondary Neoplasm
- What is being tested?
- Preoperative risk stratification, Postoperative risk stratification and Risk-based, escalating levels of care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,456 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jun 2025
- 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
- Age > or = 18 years at diagnosis.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3.
- Probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage).
- Scheduled for curative or palliative major cancer surgery, including:
- Glossectomy
- Pharyngectomy
Show all 25Show fewer
- Laryngectomy
- Neck dissection
- Esophagectomy
- Lung resection
- Gastrectomy
- Pancreatectomy
- Hepatectomy
- Colectomy
- Proctectomy
- Hysterectomy/Myomectomy
- Gynecologic reconstruction
- Prostatectomy
- Nephrectomy
- Cystectomy
- Breast reconstruction
- Flap reconstruction
- Scheduled for elective major cancer surgery at Fox Chase Cancer Center within 30 days after First Registration.
- Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document
- Geographical accessibility and willingness to return to Fox Chase Cancer Center for all preoperative and postoperative study assessments.
Who cannot join
- Clinical or tissue diagnosis of benign neuroendocrine tumor, benign neoplasm, neoplasm of uncertain behavior, or neoplasm of unspecified nature.
- Use of systemic chemotherapy and/or radiation therapy < 14 days prior to First Registration. Palliative radiation therapy is permitted for irradiating small areas of painful bony metastases that cannot be managed adequately using systemic or local analgesics
- Any condition that might interfere with the subject's participation in the study, compliance with study requirements, or in the evaluation of the study results.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Randomized Controlled Trial of Perioperative Risk Stratification and Risk-based, Protocol-driven Management in Patients Undergoing Elective Major Cancer Surgery
The primary objective of this trial is to determine if perioperative risk stratification and risk-based, protocol-driven management leads to a reduction in the rate of death or serious complications compared to standard perioperative management in patients undergoing elective major cancer surgery.
Read the detailed description
Major cancer surgery is associated with significant rates of postoperative mortality and major morbidity. Postoperative morbidity adversely impacts healthcare utilization, healthcare costs, rates of discharge to home, quality of life, rates of receipt of postoperative anti-neoplastic therapy, disease-free survival, and overall survival. The investigators hypothesize that perioperative risk stratification and risk-based, protocol-driven management (compared to standard perioperative management) will lead to a reduction in 30-day post-operative mortality or major morbidity in patients undergoing major cancer surgery. This is based on our theory that preoperative/postoperative use of newly developed, perioperative risk-prediction tools will help identify patients at increased risk of postoperative death or serious complications that might benefit from risk-based, protocol-driven perioperative management, including escalating levels of care, escalating levels of monitoring, and escalating levels of hospitalist co-management. The set of assessments and interventions in the proposed study are conceptually similar to other "bundled" interventions which have recently been recently tested and demonstrated to reduce perioperative mortality and morbidity.
- Conditions
- Tumors, Primary Neoplasm, Secondary Neoplasm, Surgery
- Being tested
- Preoperative risk stratification, Postoperative risk stratification, Risk-based, escalating levels of care, Risk-based, escalating levels of monitoring, Risk-based, escalating levels of co-management
- Keywords
- Probable cancer, Proven cancer, Elective cancer surgery, Postoperative death, Postoperative complications, Healthcare utilization, Quality of life, Adjuvant therapy, Disease-free survival, Overall survival
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative risk stratificationOther
Preoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure
Postoperative risk stratificationOther
Postoperative risk-prediction tool based on intraoperative variables
Risk-based, escalating levels of careOther
Postoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU
Risk-based, escalating levels of monitoringOther
Varying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system
Risk-based, escalating levels of co-managementOther
Varying use of Hospitalist co-management
Standard postoperative careOther
Routine postoperative care, as medically indicated
| Study group | Role | What they receive |
|---|---|---|
| Standard perioperative management | Active comparator | Standard postoperative care Receives: Other: Standard postoperative care |
| Risk-based, perioperative management | Experimental | Preoperative risk stratification Postoperative risk stratification Risk-based, escalating levels of care Risk-based, escalating levels of monitoring Risk-based, escalating levels of co-management Receives: Other: Preoperative risk stratification; Other: Postoperative risk stratification; Other: Risk-based, escalating levels of care; Other: Risk-based, escalating levels of monitoring; Other: Risk-based, escalating levels of co-management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of death or serious complications (as defined by American College of Surgeons National Surgical Quality Improvement Program [ACS NSQIP])
Measured: 30-day postoperative period
Secondary outcomes (20)
Rate of death
Measured: 30-day postoperative period
Rate of serious complication (as defined by ACS NSQIP)
Measured: 30-day postoperative period
Rate of serious/grade 3-4 adverse event (as defined by CTCAE)
Measured: 30-day postoperative period
Rate of Clavien-Dindo grade IIIa-V complication (as defined by ACS NSQIP)
Measured: 30-day postoperative period
Rate of Clavien-Dindo grade IIIa-V adverse event (as defined by CTCAE)
Measured: 30-day postoperative period
Rate of cardiac complications
Measured: 30-day postoperative period
Rate of pulmonary complications
Measured: 30-day postoperative period
Rate of renal complications
Measured: 30-day postoperative period
Rate of wound complications
Measured: 30-day postoperative period
Rate of infectious complications
Measured: 30-day postoperative period
Rate of return to the operating room
Measured: 30-day postoperative period
Rate of primary intensive care unit admission
Measured: From date of index surgery to date of hospital discharge, up to 3 months
Rate of secondary intensive care unit admission
Measured: From date of index surgery to date of hospital discharge, up to 3 months
Length of stay
Measured: From date of index surgery to date of hospital discharge, up to 3 months
Total hospital charges
Measured: From date of index surgery to date of hospital discharge, up to 3 months
Rate of discharge to home
Measured: From date of index surgery to date of hospital discharge, up to 3 months
Rate of hospital readmission
Measured: 30-day postoperative period
Health-related quality of life
Measured: Postoperative (at 30 days)
Receipt of anti-neoplastic therapy
Measured: 30-day postoperative period
Overall survival
Measured: From date of index surgery to date of death, loss to follow-up, or end of study, whichever comes first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startAug 2014
- Primary completion19 Jun 2020
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nestor F Esnaola, MD, MPH, MBA, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456389
- Sponsor's protocol ID
- SURG-073
- Acronym
- PRS
- Status last verified
- Apr 2025
- First submitted
- 1 May 2015
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Perioperative Risk Stratification and Risk-based, Protocol-driven Management in Patients Undergoing Elective Major Cancer Surgery
- ClinicalTrials.gov ID
- NCT02456389
- Acronym / sponsor ID
- PRS / SURG-073
- Conditions
- Tumors, Primary Neoplasm, Secondary Neoplasm, Surgery
- Keywords
- Probable cancer, Proven cancer, Elective cancer surgery, Postoperative death, Postoperative complications, Healthcare utilization, Quality of life, Adjuvant therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,456 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- 19 Jun 2020 (actual)
- Study completion
- Jun 2025 (estimated)
- First posted
- 28 May 2015 (estimated)
- 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 primary objective of this trial is to determine if perioperative risk stratification and risk-based, protocol-driven management leads to a reduction in the rate of death or serious complications compared to standard perioperative management in patients undergoing elective major cancer surgery.
Detailed description
Major cancer surgery is associated with significant rates of postoperative mortality and major morbidity. Postoperative morbidity adversely impacts healthcare utilization, healthcare costs, rates of discharge to home, quality of life, rates of receipt of postoperative anti-neoplastic therapy, disease-free survival, and overall survival. The investigators hypothesize that perioperative risk stratification and risk-based, protocol-driven management (compared to standard perioperative management) will lead to a reduction in 30-day post-operative mortality or major morbidity in patients undergoing major cancer surgery. This is based on our theory that preoperative/postoperative use of newly developed, perioperative risk-prediction tools will help identify patients at increased risk of postoperative death or serious complications that might benefit from risk-based, protocol-driven perioperative management, including escalating levels of care, escalating levels of monitoring, and escalating levels of hospitalist co-management. The set of assessments and interventions in the proposed study are conceptually similar to other "bundled" interventions which have recently been recently tested and demonstrated to reduce perioperative mortality and morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard perioperative management | Active comparator | Other: Standard postoperative careStandard postoperative care |
| Risk-based, perioperative management | Experimental | Other: Preoperative risk stratification, Other: Postoperative risk stratification, Other: Risk-based, escalating levels of care, Other: Risk-based, escalating levels of monitoring, Other: Risk-based, escalating levels of co-managementPreoperative risk stratification Postoperative risk stratification Risk-based, escalating levels of care Risk-based, escalating levels of monitoring Risk-based, escalating levels of co-management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Age > or = 18 years at diagnosis.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3.
- Probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage).
- Scheduled for curative or palliative major cancer surgery, including:
- Scheduled for elective major cancer surgery at Fox Chase Cancer Center within 30 days after First Registration.
Key exclusion criteria (3 listed)
- Clinical or tissue diagnosis of benign neuroendocrine tumor, benign neoplasm, neoplasm of uncertain behavior, or neoplasm of unspecified nature.
- Use of systemic chemotherapy and/or radiation therapy < 14 days prior to First Registration. Palliative radiation therapy is permitted for irradiating small areas of painful bony metastases that cannot be managed adequately using systemic or local analgesics
- Any condition that might interfere with the subject's participation in the study, compliance with study requirements, or in the evaluation of the study results.
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 |
|---|---|---|
| Preoperative risk stratificationPreoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure | Other | Risk-based, perioperative management |
| Postoperative risk stratificationPostoperative risk-prediction tool based on intraoperative variables | Other | Risk-based, perioperative management |
| Risk-based, escalating levels of carePostoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU | Other | Risk-based, perioperative management |
| Risk-based, escalating levels of monitoringVarying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system | Other | Risk-based, perioperative management |
| Risk-based, escalating levels of co-managementVarying use of Hospitalist co-management | Other | Risk-based, perioperative management |
| Standard postoperative careRoutine postoperative care, as medically indicated | Other | Standard perioperative management |
Primary outcome
Rate of death or serious complications (as defined by American College of Surgeons National Surgical Quality Improvement Program [ACS NSQIP])
Time frame: 30-day postoperative period
20 secondary outcomes
Rate of death
Time frame: 30-day postoperative period
Rate of serious complication (as defined by ACS NSQIP)
Time frame: 30-day postoperative period
Rate of serious/grade 3-4 adverse event (as defined by CTCAE)
Time frame: 30-day postoperative period
Rate of Clavien-Dindo grade IIIa-V complication (as defined by ACS NSQIP)
Time frame: 30-day postoperative period
Rate of Clavien-Dindo grade IIIa-V adverse event (as defined by CTCAE)
Time frame: 30-day postoperative period
Rate of cardiac complications
Time frame: 30-day postoperative period
Rate of pulmonary complications
Time frame: 30-day postoperative period
Rate of renal complications
Time frame: 30-day postoperative period
Rate of wound complications
Time frame: 30-day postoperative period
Rate of infectious complications
Time frame: 30-day postoperative period
Rate of return to the operating room
Time frame: 30-day postoperative period
Rate of primary intensive care unit admission
Time frame: From date of index surgery to date of hospital discharge, up to 3 months
Rate of secondary intensive care unit admission
Time frame: From date of index surgery to date of hospital discharge, up to 3 months
Length of stay
Time frame: From date of index surgery to date of hospital discharge, up to 3 months
Total hospital charges
Time frame: From date of index surgery to date of hospital discharge, up to 3 months
Rate of discharge to home
Time frame: From date of index surgery to date of hospital discharge, up to 3 months
Rate of hospital readmission
Time frame: 30-day postoperative period
Health-related quality of life
Time frame: Postoperative (at 30 days)
Receipt of anti-neoplastic therapy
Time frame: 30-day postoperative period
Overall survival
Time frame: From date of index surgery to date of death, loss to follow-up, or end of study, whichever comes first, assessed up to 60 months
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 4 Apr 2025.
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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. This study is not recruiting at the moment.
Nestor F Esnaola, MD, MPH, MBA principal investigator
Fox Chase Cancer 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 Preoperative risk stratification, Postoperative risk stratification and Risk-based, escalating levels of care in people with Tumors and Primary Neoplasm, run by Fox Chase 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 25 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: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of death or serious complications (as defined by American College of Surgeons National Surgical Quality Improvement Program [ACS NSQIP]) (time frame: 30-day postoperative period). 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 4 Apr 2025.