PET/MRI as a Predictor for Response to Preoperative Radiation Therapy and Chemotherapy in Resectable Rectal Cancer: a Pilot Study.

UNC Lineberger Comprehensive Cancer Center1 site in 1 country8 target enrollmentOctober 2012

ConditionsRectal Carcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rectal Carcinoma
Sponsor: UNC Lineberger Comprehensive Cancer Center
Enrollment: 8
Locations: 1
Primary Endpoint: Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single arm, single center pilot study of 40 patients with uT3N0 or uT1-3N+ rectal cancer receiving pre-operative chemoradiation. Subjects will undergo PET/MRI scans before and after surgery.

Detailed Description

The primary purpose of this study is to determine the negative predictive value of PET/MRI for determining pathological complete response from neoadjuvant chemoradiation.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

March 4, 2018

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

UNC Lineberger Comprehensive Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Low-lying, low- to moderate-risk pathologically-confirmed rectal cancer (stage uT3n) or uT1-3N+
•Negative workup for distant disease
•\> 18 years of age
•Pre-treatment workup completed including:
•history and physical
•CT or MRI of the abdomen and pelvis
•endoscopic tumor evaluation (biopsy, blood work to assess CEA and hematopoietic, renal and liver function)
•if female of child-bearing age, negative pregnancy test
•Recommendation to undergo preoperative concurrent chemoradiation, as determined by the treating physician
•Informed consent reviewed and signed

Exclusion Criteria

•Not deemed a candidate for preoperative chemoradiation for medical reasons, such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease
•Hemoglobin ≤ 10.0 g/dL (transfusion allowed to achieve or maintain levels)
•ANC ≤ 1,500/cubic mm³
•Platelet count ≤ 100,000/mm³
•ALT and AST ≥ 2.5 times upper level of normal (ULN)
•Alkaline phosphatase ≥ 2.5 times ULN
•Total bilirubin ≥ 1.5 times ULN
•Creatinine clearance \< 50 mL/min
•Creatinine ≥ 1.5 times ULN
•Not deemed a candidate for concurrent preoperative chemoradiation for social reasons, such as psychiatric illness