|Principal Investigator/ Physician||Clayton Smith, MD|
|Contact Email||MCI Clinical Trials|
Protocol: A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer
Inclusion 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; At least two (2) untreated core biopsy specimens from the untreated tumor (formalin-fixed, paraffin-embedded [FFPE]) must have been collected previously and be available for submission per protocol requirements.
Exclusion Criteria: Rectal cancer histology other than adenocarcinoma; Definitive clinical or radiologic evidence of metastatic disease; History of prior invasive rectal malignancy, regardless of disease-free interval; Cardiac disease that would preclude the use of any of the drugs included in the GI002 treatment regimen; Sensory or motor neuropathy >= grade 2; Active inflammatory bowel disease; Active seizure disorder uncontrolled by medication; Any antineoplastic therapy for this cancer before randomization; Synchronous colon cancer; Other invasive malignancy within 5 years before randomization; exceptions are colonic polyps, non-melanoma skin cancer or carcinoma-in-situ of the cervix; Chemotherapy within 5 years before randomization.
Clinical Trials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT02921256?term=NRG+GI002&recrs=a&rank=1
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