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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2021
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of North Carolina-Chapel Hill Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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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