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Early Identification and Treatment of Occult Metastatic Disease in Stage III Colon Cancer

Clinical Trial Details

The purpose of this study is to see if early treatment of your metastatic colorectal cancer and circulating tumor DNA (ctDNA) positivity or negativity, with FOLFIRI, Nivolumab or Encorafenib /Binimetinib/ Cetuximab, helps to prevent stage IV disease. 

After initial adjuvant chemotherapy, it is standard for individuals to begin active surveillance, where they do not receive further treatment but instead undergo frequent tumor imaging scans to see if their cancer is stable, growing, or coming back. We plan to see if additional therapy, where FOLFIRI (comprised of Irinotecan, Leucovorin, and 5-Fluorouracil), Nivolumab or Encorafenib /Binimetinib/ Cetuximab, is administered and can decrease recurrence of metastatic colorectal cancer.

   
   In this study we are looking to determine whether:

  1. There are differences in cancer recurrence in ctDNA positive participants treated with additional therapy versus put on active surveillance

  2. There are differences in health in ctDNA positive participants treated with additional therapy versus being put on active surveillance

Key Eligibility: 

  • Open to men and women above the age of 18 who have been diagnosed with resected Stage III adenocarcinoma of colorectal
  • Participants must be receiving or planning to receive standard adjuvant chemotherapy per the discretion of the treating physician
    • Standard therapy includes FOLFOX, CAPOX, or therapy with 5FU analog alone will be permitted if it constitutes appropriate standard therapy in the opinion of the treating physician
  • Participants must not have received prior neoadjuvant chemotherapy


Detailed eligibility will be reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Carina Puello, RN
(646) 962-3541
cap4008@med.cornell.edu

Li Mow
(646) 962-3378
mem9233@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2004021933

ClinicalTrials.gov:

NCT03803553

Sponsor:

18-397

Status

Not Yet Recruiting

Age Group

Adult

Sponsor