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

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.

Study Overview

• Status: Withdrawn
• Conditions: Gastrointestinal Malignancies
• Intervention / Treatment: Other: The Functional Assessment of Cancer Therapy- Colorectal

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02214
      • Massachusetts General Hospital Cancer Center
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women Hospital
    • Newton, Massachusetts, United States, 02459
      • Newton-Wellesley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tumor Sequencing; Quality of life assessments will be collected using The Functional Assessment of Cancer Therapy- Colorectal; Blood for circulating tumor DNA will be collected	Other: The Functional Assessment of Cancer Therapy- Colorectal; The Functional Assessment of Cancer Therapy- Colorectal (FACT-C) questionnaire measures health-related quality of life for people with chronic illnesses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One year local recurrence rate in participants that test positive for ctDNA compared to participants that tested negative for ctDNA	Local recurrence will be defined as recurrence of the pathologically confirmed adenocarcinoma. This may be detected by endoscopy for intraluminal recurrence or after radical surgery for radiographic evidence of extraluminal/mesorectal recurrence. The recurrence must be in the peri-anastomic site or rectal stump, or pre-sacral area. Regional nodal recurrence and lateral pelvic lymph node recurrence of rectal cancer are also included in this definition.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Local recurrence will be defined as recurrence of the pathologically confirmed adenocarcinoma. This may be detected by endoscopy for intraluminal recurrence or after radical surgery for radiographic evidence of extraluminal/mesorectal recurrence. The recurrence must be in the peri-anastomic site or rectal stump, or pre-sacral area. Regional nodal recurrence and lateral pelvic lymph node recurrence of rectal cancer are also included in this definition.	5 years
Overall rate of local recurrence by stratified KRAS/BRAF status and possibly other gene targets	Local recurrence will be defined as recurrence of the pathologically confirmed adenocarcinoma. This may be detected by endoscopy for intraluminal recurrence or after radical surgery for radiographic evidence of extraluminal/mesorectal recurrence. The recurrence must be in the peri-anastomic site or rectal stump, or pre-sacral area. Regional nodal recurrence and lateral pelvic lymph node recurrence of rectal cancer are also included in this definition.	5 years
Median EORTC QLQ-CR29 Score	European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) for Colorectal cancer(CR) 29 item questionnaire. The survey will be given at baseline, 6, 12, and 24 months. Results will be reported as the median score for each question. A score of 1 represents 'Not at All' and 4 represents 'Very Much'.	Baseline, 6 months, 12 months, 24 months
Median SF-12 Health Survey Score	The SF-12 is a 12 item validated questionnaire that assesses a participants view of their health. Scores will be normalized on a 100 point scale with higher scores representing better health.	Baseline, 6 months, 12 months, 24 months
Median LARS Score	The Low Anterior Resection Syndrome (LARS) Score is used to assess bowel dysfunction. The survey is assessed on a scale of 0-42 points, with a higher score indicating worse bowel dysfunction.	Baseline, 6 months, 12 months, 24 months
Median FIQOL Score	Fecal Incontinence Quality of Life (FIQOL) Score. Lower scores represent lower functional status.	Baseline, 6 months, 12 months, 24 months
Median Fecal Incontinence Severity Index (FISI) score	The FISI measures incontinence for gas, mucus, liquid stool,and solid stool. The survey assesses the number of times per day that the participant experiences incontinence for gas, mucus, liquid stool,and solid stool. Higher scores represent a higher degree of fecal incontinence.	Baseline, 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Clinical Genomics

Study record dates

Study Major Dates

• Study Start (Anticipated): December 31, 2019
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): October 31, 2024

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Gastrointestinal Malignancies
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 18-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No