PET/MRI as a Predictor of Response to Pre-op Chemoradiation in Resectable Rectal Cancer: a Pilot Study
Completed
- Conditions
- Rectal Carcinoma
- Registration Number
- NCT01751516
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology 4-8 weeks post-chemoradiation
- Secondary Outcome Measures
Name Time Method Disease-specific survival 5 years Overall survival 5 years Recurrence-free survival 5 years
Trial Locations
- Locations (1)
University of North Carolina-Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States