Rectal Carcinoma
Conditions
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.
Interventions
None listed
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology | 4-8 weeks post-chemoradiation |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-free survival | 5 years |
| Disease-specific survival | 5 years |
| Overall survival | 5 years |
Countries
United States
Outcome results
None listed