Clinical trial NCT03749083: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gastrointestinal Malignancies
Keywords: Gastrointestinal Malignancies
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Clinical Genomics
First posted: 2018-11-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective, observational, non-interventional study will enroll patients who have achieved a clinical complete response after treatment for rectal cancer and are undergoing standard surveillance.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: One year local recurrence rate in participants that test positive for ctDNA compared to participants that tested negative for ctDNA
timeFrame: 1 year
Secondary outcomes:
measure: Local recurrence rate at any time up to 5 years in patients who have achieved a clinical complete response after rectal cancer treatment but who test positive for circulating tumor DNA at study entry
timeFrame: 5 years
measure: Overall rate of local recurrence by stratified KRAS/BRAF status and possibly other gene targets
timeFrame: 5 years
measure: Median EORTC QLQ-CR29 Score
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Median SF-12 Health Survey Score
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Median LARS Score
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Median FIQOL Score
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Median Fecal Incontinence Severity Index (FISI) score
timeFrame: Baseline, 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women Hospital
state: Massachusetts
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Theodore S Hong, MD
role: PRINCIPAL_INVESTIGATOR
References: