Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749083
Recruitment Status : Withdrawn (Funding)
First Posted : November 21, 2018
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Clinical Genomics
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Gastrointestinal Malignancies 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : December 31, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2024
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. One year local recurrence rate in participants that test positive for ctDNA compared to participants that tested negative for ctDNA [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 5 years ]
    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.

  2. Overall rate of local recurrence by stratified KRAS/BRAF status and possibly other gene targets [ Time Frame: 5 years ]
    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.

  3. Median EORTC QLQ-CR29 Score [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    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'.

  4. Median SF-12 Health Survey Score [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    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.

  5. Median LARS Score [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    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.

  6. Median FIQOL Score [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    Fecal Incontinence Quality of Life (FIQOL) Score. Lower scores represent lower functional status.

  7. Median Fecal Incontinence Severity Index (FISI) score [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749083


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02214
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women Hospital
Boston, Massachusetts, United States, 02215
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02459
Sponsors and Collaborators
Massachusetts General Hospital
Clinical Genomics
Investigators
Layout table for investigator information
Principal Investigator: Theodore S Hong, MD Massachusetts General Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Theodore Sunki Hong, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03749083    
Other Study ID Numbers: 18-304
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Theodore Sunki Hong, Massachusetts General Hospital:
Gastrointestinal Malignancies
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms