ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05629442
• Other study ID #: 22-244
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: June 2030

Study information

• Verified date: November 2022
• Source: Massachusetts General Hospital
• Contact: Theodore S. Hong, MD
• Phone: (617) 726-6050
• Email: TSHONG1[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2030
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non Metastatic Rectal Cancer
• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mass General Cancer Center Newton-Wellesley Hospital	Newton	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	C2i Genomics, Spier Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful non-operative management		1 year
Primary	Rate of successful pathologic complete response		1 year
Secondary	Rate of local recurrence	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.	5 years
Secondary	EORTC-QLQ-CR 29 questionnaire	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.	Up to 30 months
Secondary	FACT-C questionnaire	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.	Up to 30 months
Secondary	IADL Scale	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.	Up to 30 months
Secondary	Brief Pain Inventory (BPI) questionnaire	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	Up to 30 months
Secondary	Bowel function assessment with LARS score	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	Up to 30 months
Secondary	Bowel function assessment with FISI score	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.	Up to 30 months
Secondary	Bowel function assessment with FIQOL score	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.	Up to 30 months
Secondary	Disease-free survival (DFS)	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.	Up to 30 months
Secondary	Overall Survival (OS)	Overall survival (OS) is defined as the length of time after starting rectal cancer treatment that participants are still alive.	Up to 30 months