Clinical trial NCT05629442: ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rectal Cancer
Non Metastatic Rectal Cancer
Keywords: Rectal Cancer
Non Metastatic Rectal Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: C2i Genomics
name: Spier Family Foundation
First posted: 2022-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Rate of successful non-operative management
timeFrame: 1 year
measure: Rate of successful pathologic complete response
timeFrame: 1 year
Secondary outcomes:
measure: Rate of local recurrence
timeFrame: 5 years
measure: EORTC-QLQ-CR 29 questionnaire
timeFrame: Up to 30 months
measure: FACT-C questionnaire
timeFrame: Up to 30 months
measure: IADL Scale
timeFrame: Up to 30 months
measure: Brief Pain Inventory (BPI) questionnaire
timeFrame: Up to 30 months
measure: Bowel function assessment with LARS score
timeFrame: Up to 30 months
measure: Bowel function assessment with FISI score
timeFrame: Up to 30 months
measure: Bowel function assessment with FIQOL score
timeFrame: Up to 30 months
measure: Disease-free survival (DFS)
timeFrame: Up to 30 months
measure: Overall Survival (OS)
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Newton
country: United States
facility: Mass General Cancer Center Newton-Wellesley Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Theodore S. Hong, MD
role: PRINCIPAL_INVESTIGATOR
References: