ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer

Starting soon

Conditions studied: Rectal Cancer, Non Metastatic Rectal Cancer

In brief

This prospective observational, non-therapeutic study for patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy. This research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor DNA (genetic material) ctDNA will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care C2i Genomics, a biotechnology company, and the Spier Foundation are supporting this research study by providing funding for the study.

Key facts

Study ID

NCT05629442

Run by

Massachusetts General Hospital

People needed

60

Starts

2026-10-01

Expected to finish

2030-06-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with T3, T4, or node-positive non-metastatic rectal cancer.
• Participants must have original tumor tissue (formalin-fixed, paraffin embedded specimens) available for analysis or be willing to undergo a baseline research biopsy.
• Participants must be 18 years of age or older.
• ECOG 0-2.
• Participants must be eligible for at least 3 months of FOLFOX, FOLFIRINOX/FOLFOXIRI, or CAPOX
• Participants must be eligible for long course chemoradiation to 40-54 Gy.
• Participants must be able to understand and willing to sign a written informed consent document.

You may not qualify if…

• Participants must not have any other organ cancer evident at the time of enrollment.
• Participants may not have any other concurrent serious illness that makes participation on this study impractical or clinically inappropriate.
• Participants must not be actively or planning to be pregnant or breastfeeding

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mass General Cancer Center Newton-Wellesley Hospital — Newton, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.