Rectal CancerNCT06637462
A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer
A study testing Endoscopy in people with Rectal Cancer and Adenocarcinoma of the Rectum, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Adenocarcinoma of the Rectum
- What is being tested?
- Endoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Oct 2024to 9 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Paul Romesser, MD, 646-888-2118
- Recruiting
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison, New York, 10604
Paul Romesser, MD, 646-888-2118
- Recruiting
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
Paul Romesser, MD, 646-888-2118
- Recruiting
Memorial Sloan Kettering Bergen (Limited protocol activities)
Montvale, New Jersey, 07645
Paul Romesser, MD, 646-888-2118
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Paul Romesser, MD, 646-888-2118
- Recruiting
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, 11553
Paul Romesser, MD, 646-888-2118
About this study
Official title: DISCRN in Rectal Cancer: DISseCting Response to Neoadjuvant Therapy in Rectal Cancer
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.
- Conditions
- Rectal Cancer, Adenocarcinoma of the Rectum
- Being tested
- Endoscopy
- Keywords
- rectal cancer, adenocarcinoma of the rectum, Memorial Sloan Kettering Cancer Center, 24-238
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyDiagnostic test
Standard of care endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Participants with Rectal Cancer | Experimental | Participants will be diagnosed with rectal cancer and will be undergoing standard-of-care neoadjuvant therapy. Receives: Diagnostic Test: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
To define endoscopic (clinical) response to neoadjuvant therapy at the following time points using the MSK regression schema
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start9 Oct 2024
- Primary completion9 Oct 2027 (estimated)
- Study completion9 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Romesser, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637462
- Sponsor's protocol ID
- 24-238
- Status last verified
- May 2026
- First submitted
- 9 Oct 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DISCRN in Rectal Cancer: DISseCting Response to Neoadjuvant Therapy in Rectal Cancer
- ClinicalTrials.gov ID
- NCT06637462
- Acronym / sponsor ID
- 24-238
- Conditions
- Rectal Cancer, Adenocarcinoma of the Rectum
- Keywords
- rectal cancer, adenocarcinoma of the rectum, Memorial Sloan Kettering Cancer Center, 24-238
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 9 Oct 2027 (estimated)
- Study completion
- 9 Oct 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Rectal Cancer | Experimental | Diagnostic Test: EndoscopyParticipants will be diagnosed with rectal cancer and will be undergoing standard-of-care neoadjuvant therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoscopyStandard of care endoscopy | Diagnostic test | Participants with Rectal Cancer |
Primary outcome
Clinical response
Time frame: Up to 3 years
To define endoscopic (clinical) response to neoadjuvant therapy at the following time points using the MSK regression schema
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Romesser, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy in people with Rectal Cancer and Adenocarcinoma of the Rectum, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Romesser, MD (646-888-2118, romessep@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.