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



Status:Not yet recruiting
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/23/2018
Start Date:December 31, 2018
End Date:October 31, 2024
Contact:Theodore S Hong, MD
Email:tshong1@mgh.harvard.edu
Phone:617-726-6050

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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.

In this research study, the investigator are performing blood draws to see if the presence or
absence of circulating tumor DNA (ctDNA), the genetic material in the participant's cancer's
cells, will help the investigators predict whether the participant's cancer will come back or
not.

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.
We found this trial at
4
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Matthew Abrams, MD
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Theodore S Hong, MD
Phone: 617-726-6050
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Boston, Massachusetts 02215
Principal Investigator: Harvey Mamon, MD
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2014 Washington St
Newton, Massachusetts 02462
(617) 243-6000
Principal Investigator: Lawrence S Blaskowsky, MD
Newton-Wellesley Hospital A comprehensive medical center located right in Newton on Washington Street, Newton-Wellesley Hospital...
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