Clinical Trials

Title   NRG GI002
Principal Investigator/ Physician   Clayton Smith, MD
Protocol┬áNo.   GI002
Open Date   04/11/2017
Cancer Site   Rectal
Status   Open
Sponsor   NRG
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.


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