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Trial Title:
A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer
NCT ID:
NCT06637462
Condition:
Rectal Cancer
Adenocarcinoma of the Rectum
Conditions: Official terms:
Adenocarcinoma
Rectal Neoplasms
Conditions: Keywords:
rectal cancer
adenocarcinoma of the rectum
Memorial Sloan Kettering Cancer Center
24-238
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Endoscopy
Description:
Standard of care endoscopy
Arm group label:
Participants with Rectal Cancer
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paul Romesser, MD
Phone:
646-888-2118
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited protocol activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paul Romesser, MD
Phone:
646-888-2118
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paul Romesser, MD
Phone:
646-888-2118
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited protocol activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paul Romesser, MD
Phone:
646-888-2118
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paul Romesser, MD
Phone:
646-888-2118
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited protocol activities)
Address:
City:
Rockville Centre
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paul Romesser, MD
Phone:
646-888-2118
Start date:
October 9, 2024
Completion date:
October 9, 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06637462
http://www.mskcc.org
