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
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Rate of successful non-operative management
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Theodore Sunki Hong
Principal Investigator
Massachusetts General Hospital
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.
- •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
Outcomes
Primary Outcomes
Rate of successful non-operative management
Time Frame: 1 year
Rate of successful pathologic complete response
Time Frame: 1 year
Secondary Outcomes
- Rate of local recurrence(5 years)
- EORTC-QLQ-CR 29 questionnaire(Up to 30 months)
- FACT-C questionnaire(Up to 30 months)
- Disease-free survival (DFS)(Up to 30 months)
- IADL Scale(Up to 30 months)
- Bowel function assessment with LARS score(Up to 30 months)
- Overall Survival (OS)(Up to 30 months)
- Brief Pain Inventory (BPI) questionnaire(Up to 30 months)
- Bowel function assessment with FISI score(Up to 30 months)
- Bowel function assessment with FIQOL score(Up to 30 months)