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ctDNA and Organ Preservation/Pathologic CR in 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05629442
Recruitment Status : Not yet recruiting
First Posted : November 29, 2022
Last Update Posted : November 29, 2022
Sponsor:
Collaborators:
C2i Genomics
Spier Family Foundation
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital

Study Description
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Brief Summary:

This prospective observational, non-therapeutic study for patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.

This research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor DNA (genetic material) ctDNA will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care

C2i Genomics, a biotechnology company, and the Spier Foundation are supporting this research study by providing funding for the study.


Condition or disease Intervention/treatment
Rectal Cancer Non Metastatic Rectal Cancer Other: ctDNA

Detailed Description:

The research study procedures include screening for eligibility and the collection of data and biospecimens. Non-operative management is offered as part of routine clinical care.

It is expected that up to 60 participants will be enrolled, with the goal that 55 participants will take part in this research study .

Participants enrolled on the study will remain on study for up to 60 months.

Study Design
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Study Type : Observational
Estimated Enrollment : 60 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 or Pathologic Complete Response After Neoadjuvant Therapy for Rectal Cancer
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2030
Groups and Cohorts
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Group/Cohort Intervention/treatment
EVALUATION OF CTDNA

This prospective observational, non-therapeutic study will enroll patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy/ All procedures involved with this trial will be done as per standard of care

- Except for the initial research biopsy, quality of life assessments and ctDNA collection

 Other: ctDNA
initial research biopsy, quality of life assessments and ctDNA collection


Outcome Measures
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Primary Outcome Measures :
  1. Rate of successful non-operative management [ Time Frame: 1 year ]
  2. Rate of successful pathologic complete response [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Rate of local recurrence [ Time Frame: 5 years ]
    Local recurrence is defined as cancer coming back is in the same place as the original cancer or very close to it. Local recurrence will be assessed in participants who achieved a Clinical Complete Response (cCR) or Near Complete Clinical Response (nCR) after rectal cancer treatment by ctDNA status with the C2i assay.

  2. EORTC-QLQ-CR 29 questionnaire [ Time Frame: Up to 30 months ]

    European Organization for Research and Treatment of Cancer-Colorectal surgery (EORTC-QLQ-CR 29) is a 29-item patient-reported questionnaire to assess health-related quality of life in patients with colorectal cancer.

    Each question ranges in score from 1 to 4. Higher scores indicate higher levels of symptoms or less functioning.


  3. FACT-C questionnaire [ Time Frame: Up to 30 months ]

    Functional Assessment of Cancer Therapy- Colorectal (FACT-C) is a 37-item patient-reported questionnaire to assess quality of life in patients with colorectal. FACT-C questions are divided into four primary quality of life domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being.

    Participants rate each item on the questionnaire from 0 to 4. Total score range is from 0 to 136. Higher scores generally indicate better quality of life.


  4. IADL Scale [ Time Frame: Up to 30 months ]

    Instrumental Activities of Daily Living (IADL) Scale is an 8-item patient-reported questionnaire with a summary score from 0 (low function) to 8 (high function).

    IADLs are things you do every day to independently take care of yourself and your home.


  5. Brief Pain Inventory (BPI) questionnaire [ Time Frame: Up to 30 months ]

    Brief Pain Inventory (BPI) is a questionnaire to measure the severity and interference of pain on daily functions in participants with cancer.

    BPI scale total score:

    • worst pain score: 1-4 = mild pain
    • worst pain score: 5-6 = moderate pain
    • worst pain score: 7-10 = severe pain

  6. Bowel function assessment with LARS score [ Time Frame: Up to 30 months ]

    Low Anterior Resection Syndrome (LARS) score (LARS) is a 5-item questionnaire to assess bowel dysfunction following a low anterior resection for rectal cancer.

    LARS total score:

    • 0-20 = no dysfunction
    • 21-29 = minor dysfunction
    • 30-42 = major dysfunction

  7. Bowel function assessment with FISI score [ Time Frame: Up to 30 months ]

    Fecal Incontinence Severity Index (FISI) is a patient-reported questionnaire that helps quantify the impact of adult incontinence leakage on quality of life.

    Total score range is from 0 to 61. Higher scores indicate a higher perceived severity of fecal incontinence and related impact on quality of life.


  8. Bowel function assessment with FIQOL score [ Time Frame: Up to 30 months ]

    Fecal Incontinence Quality of Life (FIQOL) is a 29-item patient-reported questionnaire to assess quality of life of participants with fecal incontinence. The questionnaire has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment.

    Subscale scores range from 1 to 5 and are the average response to all items on each scale. Total FIQOL score is the sum of all four subscales. Lower scores indicate lower functional status and related quality of life.


  9. Disease-free survival (DFS) [ Time Frame: Up to 30 months ]
    Disease-free survival (DFS) is defined as the length of time after completion of rectal cancer treatment that the patient survives without any signs or symptoms of that cancer.

  10. Overall Survival (OS) [ Time Frame: Up to 30 months ]
    Overall survival (OS) is defined as the length of time after starting rectal cancer treatment that participants are still alive.


Biospecimen Retention:   Samples With DNA
biospecimen submission should include both tissue and blood samples:

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This prospective observational, non-therapeutic study will enroll patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.
Criteria

Inclusion Criteria:

  • Participants with T3, T4, or node-positive non-metastatic rectal cancer.
  • Participants must have original tumor tissue (formalin-fixed, paraffin embedded specimens) available for analysis or be willing to undergo a baseline research biopsy.
  • Participants must be 18 years of age or older.
  • ECOG 0-2.
  • Participants must be eligible for at least 3 months of FOLFOX, FOLFIRINOX/FOLFOXIRI, or CAPOX
  • Participants must be eligible for long course chemoradiation to 40-54 Gy.
  • Participants must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

  • Participants must 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.
  • Participants must not be actively or planning to be pregnant or breastfeeding
Contacts and Locations
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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): NCT05629442


Contacts
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Contact: Theodore S. Hong, MD (617) 726-6050 TSHONG1@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Contact: Theodore Hong, MD    617-726-6050    TSHONG1@mgh.harvard.edu   
Principal Investigator: Theodore Hong, MD         
Mass General Cancer Center Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
Contact: Theodore Hong, MD    617-219-1230    TSHONG1@mgh.harvard.edu   
Sub-Investigator: Theodore Hong, MD         
Sponsors and Collaborators
Massachusetts General Hospital
C2i Genomics
Spier Family Foundation
Investigators
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Principal Investigator: Theodore S. Hong, MD Massachusetts General Hospital
More Information
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Responsible Party: Theodore Sunki Hong, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT05629442    
Other Study ID Numbers: 22-244
First Posted: November 29, 2022    Key Record Dates
Last Update Posted: November 29, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

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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:
Rectal Cancer
Non Metastatic Rectal Cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases