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New treatment option for Rectal Cancer
Official title A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer
ClinicalTrials.gov ID: NCT06637462
What this study is testing
- What it's testing
- The purpose of the study is to learn more about how the body responds to standard treatment (chemoradiation and chemotherapy). The study will use the results of testing down on participants' blook, tissue, and scans to learn more about how people with rectal cancer respond to chemoradiation and chemotherapy treatment and if it is useful for predicting whether a person's cancer get better, gets worse, or stats the same after treatment.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years of age or older on day of signing informed consent.
- Have a histologically confirmed diagnosis of invasive adenocarcinoma of the rectum with no known mismatch repair deficiency or Her2 amplification.
- Eligible for and plan to initiate standard-of-care therapy with any of the following regimens:
- Induction fluoropyrimidine (capecitabine [preferred] or 5-FU) based chemoradiation
- With plan for consolidative CAPEOX, FOLFOX, or FOLIRINOX
You likely can't join if
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works...
- Patients with prior external beam radiation therapy to the pelvis or brachytherapy seed implantation of the prostate.
- Patients who are pregnant or breastfeeding.
- Men or women not using effective contraception.
- Patients with a contraindication to MR imaging.
- Patients on blood thinners prohibiting endoluminal tumor biopsies.
See the full eligibility criteria
- 18 years of age or older on day of signing informed consent.
- Have a histologically confirmed diagnosis of invasive adenocarcinoma of the rectum with no known mismatch repair deficiency or Her2 amplification.
- Eligible for and plan to initiate standard-of-care therapy with any of the following regimens:
- Induction fluoropyrimidine (capecitabine [preferred] or 5-FU) based chemoradiation
- With plan for consolidative CAPEOX, FOLFOX, or FOLIRINOX
- Woman with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use an effective contraceptive method. A woman of childbearing potential is defined as one who is biologically...
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen.
- Patients with prior external beam radiation therapy to the pelvis or brachytherapy seed implantation of the prostate.
- Patients who are pregnant or breastfeeding.
- Men or women not using effective contraception.
- Patients with a contraindication to MR imaging.
- Patients on blood thinners prohibiting endoluminal tumor biopsies.
The study team makes the final eligibility decision.
Where it's taking place
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States; Rockville Centre, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.