RightFit
Not yet recruitingPhase 2

ctDNA-Informed Management of Early-Stage Rectal Cancer

ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "At Time A after TNT is completed and based on ctDNA assay results, the clinical decision will be made to put participants into one of two arms: the ctDNA informed management arm (Watchful Waiting \[WW\] surveillance) or the post TNT SOC surgery arm; participants will be monitored for ctDNA positivity for up to 5 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase 2 study is for adults with early-stage rectal cancer. It tests whether the Signatera Genome test, which looks for cancer DNA in the blood, can help guide treatment. Researchers will check whether treatment leaves no cancer in removed tissue and how long people stay free of cancer.

This is a phase 2 pragmatic study to examine the utility of ctDNA-informed treatment management for participants with early-stage rectal cancer using the Signatera Genome assay. The primary aims are to 1) assess pathologic complete response (path CR) in the ctDNA informed management arm; 2) assess pathologic complete response (path CR) in the post total neoadjuvant therapy (TNT) standard of care (SOC) surgery arm; and 3) assess disease free survival (DFS) in the ctDNA informed management arm.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have rectal adenocarcinoma, a type of rectal cancer, confirmed by a tissue sample that is available for the study’s cancer DNA test.
  • For group A: Be able to receive chemotherapy and chemotherapy with radiation before surgery.
  • For group B: Have already received at least 4 rounds of CAPEOX or 6 rounds of FOLFOX chemotherapy, plus chemotherapy with radiation to the pelvis totaling at least 45 Gy in 25 treatments.
  • Be at least 18 years old when you agree to join.
  • Be able to understand the study consent form and willing to sign it.
  • Be able and willing to follow the study visit schedule and requirements.

Who can't join

  • Have had treatment for rectal cancer before, unless you are in group B.
  • Have cancer that has spread to distant parts of the body, shown by scans within 8 weeks before joining.
  • Receive hemodialysis, a treatment that uses a machine to clean your blood.
  • Have any condition that the study doctor believes could make the study unsafe for you or keep you from following study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Tumor tissue histologically confirming rectal adenocarcinoma that is available for Natera ctDNA assay. * Cohort A only: Patients appropriate for receiving TNT including chemotherapy and chemoradiation. * Cohort B only: TNT must have included at least 4 cycles of CAPEOX or 6 cycles of FOLFOX and at least 45 Gy in 25 fractions to the pelvis during chemoradiation. * Patients ≥18 years of age at time of consent. * Ability to understand and willingness to sign the informed consent form (ICF). * Ability and stated willingness to adhere to the study visit schedule and protocol procedures/requirements. Exclusion Criteria: * Prior treatment for rectal cancer, except for cohort B. * Evidence of distant metastatic disease on staging imaging (CT chest with abdominopelvic imaging by CT or MRI) within 8 weeks of enrollment. * Patients on hemodialysis. * Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial

Study sites (1)

CA