Page 11 - Delaware Medical Journal - December 2017
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CANCER CLINICAL TRIAL CASE REPORT
PROTOCOL OF THE MONTH
NRG GI002: A Phase II Clinical Trial Platform of Sensitization Utilizing Total NeoadjuvantTherapy (TNT) in Rectal Cancer
Primary Objective:
To demonstrate an absolute improvement in Neoadjuvant Rectal Cancer (NAR) score for the experimental regimen as compared to control.
Secondary Objectives:
To compare overall survival.
To compare disease-free survival.
To estimate the rate of disease progression during chemotherapy (prior to chemoradiation).
To compare the rate of pathologic complete response (nodes and tumor). Pathologic response to preoperative therapy
invasive tumor cells on pathologic examination of the primary rectal cancer (or tissue from the area where the tumor had
been if there is a complete clinical response).
To compare the rate of clinical complete response rate (cCR). Presence or absence of complete clinical response will
be asessed immediately prior to surgery by perioperative digital rectal exam and either sigmoidoscopy or proctoscopy.
To compare the rate of negative circumferential margin.
To compare the rate of completion of all cycles of neoadjuvant chemotherapy.
To compare the rate of completion of full course of chemoradiation.
To compare the rate of sphincter preservation.
To compare the toxicity and safety between interventions.
To explore the correlative molecular predictors of response and distant failure.
Eligibility Criteria:
Diagnosis of adenocarcinoma of the rectum with the major portion of the tumor intact.
The tumor must be clinically determined to be locally advanced Stage II or Stage III rectal cancer.
Patients must have the ability to swallow and retain oral medication.
before randomization.
infections.
Treatment:
ARM A:
ARM B:
The Delaware Cancer Treatment Program (DCTP)
provides medical insurance coverage to uninsured Delawareans for the treatment of cancer.
For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
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