NRG-GI002

A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer

Principal Investigator

Thomas George, MD

Status

Closed to Accrual

Disease Site

Gastrointestinal [GI]

Anal Canal

Phase

II

Developmental Therapeutics

No

Primary Objective

To demonstrate an absolute improvement in Neoadjuvant Rectal Cancer (NAR) score for the experimental regimen as compared to control.

Patient Population

Patients with tumor clinically determined to be locally advanced Stage II or Stage III rectal cancer, defined as meeting any one of the following criteria:

 
• distal location (as defined by measurement on MRI, ERUS/pelvic CT [with IV contrast] scan or palpable on digital rectal exam [DRE]): cT3-4 ≤ 5 cm from the anal verge, any N
 
• bulky: any cT4 with the majority of the untreated tumor < 12 cm from the anal verge or below the peritoneal reflection as determined by the treating surgeon, or evidence that the tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on MRI or ERUS/pelvic CT (with IV contrast) scan
 
• high risk for metastatic disease with 4 or more regional lymph nodes (cN2)
 
• not a candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy (as planned by the primary surgeon)

Target Accrual

174