This trial is active, not recruiting.

Condition rectal carcinoma
Sponsor UNC Lineberger Comprehensive Cancer Center
Start date October 2012
End date August 2014
Trial size 8 participants
Trial identifier NCT01751516, LCCC1225


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology
time frame: 4-8 weeks post-chemoradiation

Secondary Outcomes

Recurrence-free survival
time frame: 5 years
Disease-specific survival
time frame: 5 years
Overall survival
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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 - Not deemed a surgical candidate - Currently active second malignancy, except non-melanoma skin cancer, non-invasive bladder cancer, low risk adenocarcinoma of the prostate and carcinoma in situ of the cervix - Previous pelvic radiation therapy - History of severe reaction to gadolinium - Inability to tolerate MRI (e.g., inability to lie flat for > 1 hour) - Presence of a pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes - Body Mass Index (BMI) > 35 - Pregnant or lactating female

Additional Information

Official title PET/MRI as a Predictor for Response to Preoperative Radiation Therapy and Chemotherapy in Resectable Rectal Cancer: a Pilot Study.
Principal investigator Joel E Tepper, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.