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Not yet recruiting NCT05629442

ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer

— Observational Rectal Cancer Non Metastatic Rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ctDNA.
Who it may be relevant to
Registry conditions: Rectal Cancer, Non Metastatic Rectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Rate of successful non-operative management [Time frame: 1 year]
  • Rate of successful pathologic complete response [Time frame: 1 year]
Secondary outcome measures (10)
  • Rate of local recurrence [Time frame: 5 years]
  • EORTC-QLQ-CR 29 questionnaire [Time frame: Up to 30 months]
  • FACT-C questionnaire [Time frame: Up to 30 months]
  • IADL Scale [Time frame: Up to 30 months]
  • Brief Pain Inventory (BPI) questionnaire [Time frame: Up to 30 months]
  • Bowel function assessment with LARS score [Time frame: Up to 30 months]
  • Bowel function assessment with FISI score [Time frame: Up to 30 months]
  • Bowel function assessment with FIQOL score [Time frame: Up to 30 months]
  • Disease-free survival (DFS) [Time frame: Up to 30 months]
  • Overall Survival (OS) [Time frame: Up to 30 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Massachusetts General Hospital — Boston
  • Mass General Cancer Center Newton-Wellesley Hospital — Newton

Identifiers

NCT: NCT05629442 · 22-244

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗