Study on Using ctDNA to Guide Treatment for Early-Stage Rectal Cancer

Sponsor: University of California, Davis

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07209215

Provider View

This clinical trial is exploring how using a special blood test called ctDNA can help guide treatment decisions for people with early-stage rectal cancer. The study aims to see if this approach can improve treatment outcomes and help patients live longer without the disease returning.

Patient Parameters

Program Overview

This study is investigating whether a blood test that detects cancer DNA (ctDNA) can help doctors make better treatment decisions for patients with early-stage rectal cancer. The main goals are to see if this approach can lead to complete cancer disappearance in patients and to compare it with the standard treatment approach. The study will also look at how long patients remain free of cancer when using ctDNA to guide their treatment.

Description

Participants in this study will be divided into two groups. Group A includes patients who are suitable for receiving a treatment called total neoadjuvant therapy (TNT), which involves chemotherapy and radiation. Group B includes patients who have already completed TNT either at UC Davis Health or elsewhere. After completing TNT, a blood test will be used to check for cancer DNA. Based on the results, patients will either be closely monitored without immediate surgery (Watchful Waiting) or will undergo standard surgery. Patients will be monitored for up to 5 years to check for any signs of cancer returning.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of rectal adenocarcinoma, with tumor tissue available for the ctDNA test.
  • For Group A: Be suitable for receiving total neoadjuvant therapy (TNT), which includes chemotherapy and radiation.
  • For Group B: Have completed TNT, including at least 4 cycles of CAPEOX or 6 cycles of FOLFOX chemotherapy, and received at least 45 Gy of radiation to the pelvis.
  • Be 18 years or older.
  • Be able to understand and willing to sign the consent form.
  • Be willing to follow the study schedule and procedures.

Exclusion Criteria

  • Have had previous treatment for rectal cancer, except for those in Group B.
  • Have evidence of cancer spread to other parts of the body based on recent imaging tests.
  • Be on hemodialysis.
  • Have any condition that the study doctor believes would affect safety or ability to follow the study.

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