Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05454280

Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)

Led by Fox Chase Cancer Center · Updated on 2025-07-08

880

Participants Needed

1

Research Sites

315 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a randomized trial of intensified post-discharge surveillance (Intervention Arm) versus standard post-discharge surveillance (Control Arm).

CONDITIONS

Official Title

Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years at diagnosis
  • ECOG performance status of 0, 1, or 2 (fully active or ambulatory with some activity restrictions but able to care for self)
  • Probable or confirmed primary or recurrent malignant neoplasm, neuroendocrine tumor, or carcinoma in situ at any stage
  • Scheduled for elective major cancer surgery at FCCC within 30 days after registration
  • Surgery must be elective (not urgent or emergency) with planned admission from home
  • Ability to understand and sign informed consent and HIPAA documents
  • Willingness and ability to return to FCCC for all preoperative and postoperative study assessments
  • Undergoing major operations to treat malignancies of head and neck, chest, abdomen, genitourinary tract, or extremities
Not Eligible

You will not qualify if you...

  • Undergoing biopsies, outpatient procedures, superficial resections of skin cancers, or purely palliative operations
  • Any condition interfering with study participation, compliance, or evaluation
  • Undergoing elective surgery not listed in the Surgical Risk Calculator at second registration
  • Patients whose scheduled procedure was suspended due to unexpected findings such as carcinomatosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States, 19111-2497

Actively Recruiting

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Research Team

J

Jason Castellanos, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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