Rectal Carcinoma Clinical Trial
Official title:
PET/MRI as a Predictor for Response to Preoperative Radiation Therapy and Chemotherapy in Resectable Rectal Cancer: a Pilot Study.
NCT number | NCT01751516 |
Other study ID # | LCCC1225 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2012 |
Est. completion date | March 4, 2018 |
Verified date | January 2021 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | March 4, 2018 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina-Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology | 4-8 weeks post-chemoradiation | ||
Secondary | Recurrence-free survival | 5 years | ||
Secondary | Disease-specific survival | 5 years | ||
Secondary | Overall survival | 5 years |
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