A Study of the Role of Circulating Tumor DNA in Predicting the Likelihood of Organ Preservation After Clinical Complete Response to Neoadjuvant Therapy for Rectal Cancer

Withdrawn before enrolling

Conditions studied: Gastrointestinal Malignancies

In brief

In this research study, the investigators are looking to see if the circulating tumor DNA (genetic material), also known as ctDNA, in the blood will help them predict whether the participant's cancer will come back.

Key facts

Study ID

NCT03749083

Run by

Massachusetts General Hospital

People needed

0

Starts

2019-12-31

Expected to finish

2024-10-31

Last updated by the study team

2019-07-08

Who can join

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

You may qualify if…

• Participants must have achieved a clinical complete response (cCR) within 3 months of last therapy - defined as absence of residual ulceration, mass or mucosal irregularity at endoscopic assessment - following neoadjuvant therapy with chemoradiation or chemotherapy followed by radiation for stage I, II, or III non-metastatic rectal cancer. (Whitening of the mucosa with presence of telangiectasia will be accepted as cCR.)
• Participants must have original tumor tissue (formalin-fixed, paraffin-embedded specimens) available for analysis
• Participants must be 18 years of age or older.
• Participants must be able to understand and willing to sign a written informed consent document.
• Participants must have received long course chemoradiation to 40-54 Gy.
• Participants must have received at least 4 cycles of FOLFOX
• Participant must be no more than 3 months past the conclusion of initial chemoradiation of rectal cancer (i.e., end of chemoradiation).

You may not qualify if…

• Participants may 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.

Where it is running

• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Brigham and Women Hospital — Boston, Massachusetts, United States
• Newton-Wellesley Hospital — Newton, Massachusetts, United States

Full record on ClinicalTrials.gov

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