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.
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.
1. Age > or = 18 years at diagnosis.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3.
3. Probable (i.e., clinically suspicious) or histologically/cytologically confirmed,
primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or
carcinoma in situ (any stage).
4. Scheduled for curative or palliative major cancer surgery, including:
- Neck dissection
- Lung resection
- Gynecologic reconstruction
- Breast reconstruction
- Flap reconstruction
5. Scheduled for elective major cancer surgery at Fox Chase Cancer Center within 30 days
after First Registration.
6. Ability to understand and willingness to sign a written informed consent and Health
Insurance Portability and Accountability Act (HIPAA) consent document
7. Geographical accessibility and willingness to return to Fox Chase Cancer Center for
all preoperative and postoperative study assessments.
1. Clinical or tissue diagnosis of benign neuroendocrine tumor, benign neoplasm,
neoplasm of uncertain behavior, or neoplasm of unspecified nature.
2. 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
3. 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.
Nestor F Esnaola, MD, MPH, MBA
Fox Chase Cancer Center
John W Lee, CCRP
Philadelphia, Pennsylvania 19111
Nestor Esnaola, MD, MPH, MBA
Site Status: Recruiting