Study ID: NRG-GI002
A phase II clinical trial platform of sensitization utilizing total neoadjuvant therapy in rectal cancer
This treatment trial is for patients who have been diagnosed with locally advanced cancer of the rectum and in need of surgery. Researchers seek to determine overall survival and disease-free survival in patients administered a specific drug treatment regimen.
Prior to surgery, all study participants receive eight cycles of mFOLFOX6, a combination chemotherapy regimen used to treat colorectal cancer. After chemotherapy, patients are treated with radiotherapy for three to four weeks, as well as capecitabine, an FDA-approved oral drug that works by slowing the growth of cancer cells. One group of patients will also receive the experimental drug veliparib, a potential anti-cancer medication. And a third group will receive the FDA-approved immunotherapy drug Keytruda®.
The patient must be diagnosed with stage II or III adenocarcinoma of the rectum with major portion of tumor intact and < 12cm from the anal verge or below the peritoneal reflection as determined by the treating surgeon. Must be locally advanced, defined as meeting any one of the following criteria:
- Distal location, scan or palpable on DRE
- Bulky: any cT4 or evidence that the tumor is adjacent to the mesorectal fascia on MRI or ERUS/pelvic CT (with IV contrast) scan
- High risk for metastatic disease with > 4 regional bulky lymph nodes (cN2)
- Not a candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy (as planned by the primary surgeon)
All patients receive mFOLFOX6, radiotherapy and capecitabine. The randomized groups then receive:
- Arm 1: the above-noted regimen
- Arm 2: veliparib
- Arm 3: pembrolizumab
- Must have been diagnosed with non-recurrent, locally advanced rectal cancer and not yet undergone surgical excision
- Must have no synchronous colon cancer
- Patients must be able to swallow and retain oral medications