Adenocarcinoma of the Rectum, Rectal Cancer
Conditions
Keywords
rectal cancer, adenocarcinoma of the rectum, Memorial Sloan Kettering Cancer Center, 24-238
Brief summary
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.
Interventions
DIAGNOSTIC_TESTEndoscopy
Standard of care endoscopy
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 capable of becoming pregnant. Reliable contraception should be used from the time of screening and must be continued throughout the duration of treatment as per standard of care.
Exclusion criteria
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response | Up to 3 years | To define endoscopic (clinical) response to neoadjuvant therapy at the following time points using the MSK regression schema |
Countries
United States
Contacts
CONTACTPaul Romesser, MD
CONTACTAndrea Cercek, MD
PRINCIPAL_INVESTIGATORPaul Romesser, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed