Rectal CancerROBINNCT05943210
The Radiation Oncology-Biology Integration Network (ROBIN) Molecular Characterization Trial (MCT) of Standard Short Course Radiotherapy for Rectal Cancer
A study testing Short Course Radiation Therapy (scRT) and Total Mesenteric Excision (TME) in people with Rectal Cancer, run by Weill Medical College of Cornell University at 5 sites in United States.
Trial summary
This trial (molecular characterization trial) focuses on rectal cancer, a common cancer that is treated with radiotherapy (RT) as standard of care and represents a setting in which to study the effects of RT on the immune system. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Short Course Radiation Therapy (scRT) and Total Mesenteric Excision (TME)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- 22 May 2023to 31 May 2028
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- Age ≥ 18 years
- ECOG performance status 0-1
- cT2-T3N0 or cT1-3N1 or cT4 or cN2
- Rectal cancer amenable to total mesorectal excision
- No evidence of distant metastases
Show all 14Show fewer
- No prior pelvic radiation therapy
- No prior chemotherapy or surgery for rectal cancer
- Total neoadjuvant therapy (short course radiotherapy followed by consolidative chemotherapy) is allowed
- No infections requiring systemic antibiotic treatment
- Hgb >8.0 gm/dL, PLT > 150,000/mm3, total bilirubin ≤ 1.5x upper limit of normal, AST ≤ upper limit of normal, ALT ≤ 3x upper limit of normal
- Patients must read, agree to, and sign a statement of informed consent prior to participation in this study. Patients who do not read or understand English or eligible but must have the consent form read to them in its entirety by an official translator. Informed consent for non-literate or non-English speaking patients may not be obtained by using a relative or a member of the patient's clinical team as a translator.
- Female participants or reproductive potential, defined as not surgically sterilized and between menarche and 1 year post menopause, must have a negative serum pregnancy test within 4 weeks prior to initiation of study treatment.
- Women with childbearing potential who are negative for pregnancy (urine or blood) and who agree to use effective contraceptive methods. A woman of childbearing potential is defined by one who is biologically capable of becoming pregnant. Reliable contraception should be used from trial screening and must be continued throughout the study.
Who cannot join
- Recurrent rectal cancer
- Primary unresectable rectal cancer is defined as a primary rectal tumor which, on the basis of either physical exam or pelvic MRI, is deemed to be adherent or fixed to adjacent pelvic structures (en bloc resection will not be achieved with negative margins).
- Patients who have received prior pelvic radiotherapy
- Patients with prior allogenic stem cell or solid organ transplantation.
- Patients receiving treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor-α agents) administered at >10 mg/day prednisone or equivalent within 2 weeks prior to initiation of study treatment.
- Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment would make them inappropriate candidates for entry into this study
- Patients receiving other anticancer or experimental therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody, or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.
- Women who are pregnant or breastfeeding. Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to four weeks after the study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 10065
Izael Nino, izn4001@med.cornell.edu
Mary Palmer, map9505@med.cornell.edu
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
Fauzia Arif, farif@uchicagomedicine.org
Sean Pitroda, M.D.
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
ManiDeepika Katta, 732-427-6212, mk1570@cinj.rutgers.edu
Salma Jabbour, M.D.
- Recruiting
Weill Cornell Medical College
New York, New York, 10065
Maahi Patel, 646-962-3118, map4044@med.cornell.edu
Fabiana Gregucci, M.D., 646-962-2199, fgr4002@med.cornell.edu
- Not yet recruiting
New York Presbyterian Hospital - Queens
New York, New York, 11355
Hina Ali, M.D., 718-670-1541, hia4002@med.cornell.edu
Krystalle Lyons, 718-670-1574, krl4003@med.cornell.edu
About this study
Official title: The Radiation Oncology-Biology Integration Network (ROBIN) Molecular Characterization Trial (MCT) of Standard Short Course Radiotherapy for Rectal Cancer.
This trial (molecular characterization trial) focuses on rectal cancer, a common cancer that is treated with radiotherapy (RT) as standard of care and represents a setting in which to study the effects of RT on the immune system.
Read the detailed description
The study aims to test the hypothesis that the radiation therapy will assist in targeting the rectal cancer by mounting a robust immune response against the rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Short Course Radiation Therapy (scRT), Total Mesenteric Excision (TME)
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Course Radiation Therapy (scRT)Radiation
Eligible patients will receive short course radiation therapy (scRT) of 25Gy over 5 days (fractions) for their localized rectal cancer. Research bloods stool and tissue will be collected at three time points: Baseline, end of radiation therapy and at surgery.
Total Mesenteric Excision (TME)Procedure or surgery
Subjects are expected to undergo total mesenteric Excision(TME) even if subjects have achieved complete response by imaging.TME is a specific surgical technique used in the treatment of rectal cancer in which the bowel with the tumor is entirely removed along with surrounding fat and lymph nodes.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort | Other | Eligible patients will receive short course radiation therapy (scRT) of 25Gy over 5 days (fractions) for their localized rectal cancer. Research bloods stool and tissue will be collected at three time points: Baseline, end of radiation therapy and at surgery. Receives: Radiation: Short Course Radiation Therapy (scRT); Procedure: Total Mesenteric Excision (TME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tissue biopsies obtained from treated patients
To conduct a multi-centric prospective clinical trial of standard short course RT in the neoadjuvant setting of rectal cancer (MCT), with harmonized tissue acquisition and immune characterization across seven international centers, and assess quality of life during MCT and pathological response at surgery.
Measured: Baseline
Number of tissue biopsies obtained from treated patients
To conduct a multi-centric prospective clinical trial of standard short course RT in the neoadjuvant setting of rectal cancer (MCT), with harmonized tissue acquisition and immune characterization across seven international centers, and assess quality of life during MCT and pathological response at surgery.
Measured: Week 1
Number of tissue biopsies obtained from treated patients
To conduct a multi-centric prospective clinical trial of standard short course RT in the neoadjuvant setting of rectal cancer (MCT), with harmonized tissue acquisition and immune characterization across seven international centers, and assess quality of life during MCT and pathological response at surgery.
Measured: Week 6
Number of research specimens obtained before RT.
To obtain a unique set of biospecimens of optimal quality for cutting-edge imaging and multi-omics analyses at the single cell level that are spatially integrated, obtained longitudinally before and after RT and at the time of surgery.
Measured: Baseline
Number of research specimens obtained after RT.
To obtain a unique set of biospecimens of optimal quality for cutting-edge imaging and multi-omics analyses at the single cell level that are spatially integrated, obtained longitudinally before and after RT and at the time of surgery.
Measured: Week 1
Number of research specimens obtained at the time of surgery.
To obtain a unique set of biospecimens of optimal quality for cutting-edge imaging and multi-omics analyses at the single cell level that are spatially integrated, obtained longitudinally before and after RT and at the time of surgery.
Measured: Week 6
Secondary outcomes (13)
Changes in tumor morphology from pre-treatment and post-treatment MRI will be measured.
All patients will have pre-treatment and post-treatment multi-modality MRI. Both conventional and Deep learning based radiomics (DLR) approaches will be applied to study the changes in the tumor morphology at each time point. Deep learning-based radiomics (DLR) was developed to extract deep information from multiple modalities of magnetic resonance (MR) images.
Measured: Baseline, Week 1
Changes in tumor morphology from pre-treatment and post-treatment CT will be measured.
All patients will have pre-treatment and post-treatment multi-modality planning CTs. Both conventional and Deep learning based radiomics (DLR) approaches will be applied to study the changes in the tumor morphology at each time point. Deep learning-based radiomics (DLR) was developed to extract deep information from multiple modalities of magnetic resonance (MR) images.
Measured: Baseline, Week 1
Changes in tumor texture from pre-treatment and post-treatment MRI will be measured.
All patients will have pre-treatment and post-treatment multi-modality MRI. Tumor texture analysis will be measured using dynamic contrast enhanced (DCE)-MRI. Tumor texture has made the most significant contribution in predicting response for patients receiving radiotherapy Both conventional and Deep learning based radiomics (DLR) approaches will be applied to study the changes in the tumor texture at each time point.
Measured: Baseline, Week 1
Changes in tumor texture from pre-treatment and post-treatment CT will be measured.
All patients will have pre-treatment and post-treatment multi-modality planning CTs. Tumor texture analysis will be measured using dynamic contrast enhanced (DCE)-MRI. Tumor texture has made the most significant contribution in predicting response for patients receiving radiotherapy Both conventional and Deep learning based radiomics (DLR) approaches will be applied to study the changes in the tumor texture at each time point.
Measured: Baseline, Week 1
Changes in enhancement kinetics from pre-treatment and post-treatment MRI will be measured.
All patients will have pre-treatment and post-treatment multi-modality MRI. Both conventional and Deep learning based radiomics (DLR) approaches will be applied to study the changes in the enhancement kinetics at each time point. Deep learning-based radiomics (DLR) was developed to extract deep information from multiple modalities of magnetic resonance (MR) images. Enhancement kinetics of tumor indicates whether the tumor is benign or malignant. If enhancement kinetics is rapid is indicative of malignancy and if it is delayed, it is indicative of benign tumor.
Measured: Baseline, Week 1
Changes in enhancement kinetics from pre-treatment and post-treatment CT will be measured.
All patients will have pre-treatment and post-treatment multi-modality planning CTs. Both conventional and Deep learning based radiomics (DLR) approaches will be applied to study the changes in the enhancement kinetics at each time point. Deep learning-based radiomics (DLR) was developed to extract deep information from multiple modalities of magnetic resonance (MR) images. Enhancement kinetics of tumor indicates whether the tumor is benign or malignant. If enhancement kinetics is rapid is indicative of malignancy and if it is delayed, it is indicative of benign tumor.
Measured: Baseline, Week 1
Changes in functional diffusion patterns from pre-treatment and post-treatment MRI will be measured.
All patients will have pre-treatment and post-treatment multi-modality MRI. Functional diffusion patterns are used to measure the alterations in cell density/cell membrane function and microenvironment. Diffusion patterns can be used as an indicator to predict treatment efficacy by measuring the changes in the tumor microevironment. Both conventional and Deep learning based radiomics (DLR) approaches will be applied to study the changes in the function diffusion patterns at each time point. Deep learning-based radiomics (DLR) was developed to extract deep information from multiple modalities of magnetic resonance (MR) images.
Measured: Baseline, Week 1
Changes in functional diffusion patterns from pre-treatment and post-treatment CT will be measured.
All patients will have pre-treatment and post-treatment multi-modality planning CTs. Functional diffusion patterns are used to measure the alterations in cell density/cell membrane function and microenvironment. Diffusion patterns can be used as an indicator to predict treatment efficacy by measuring the changes in the tumor microevironment. Both conventional and Deep learning based radiomics (DLR) approaches will be applied to study the changes in the function diffusion patterns at each time point. Deep learning-based radiomics (DLR) was developed to extract deep information from multiple modalities of magnetic resonance (MR) images.
Measured: Baseline, Week 1
Changes in Cellular stress (quantification of reactive Oxygen species (ROS))
ROS is measured using CellRox dye that reacts with ROS and emits fluorescence.
Measured: Baseline, Week 1, Week 6
Changes in immunological fitness related to radio-responsiveness and their associated pathological response will be measured by quantifying senescence using vital dye DDAO.
7-hydroxy-9H-(1,3-dichloro-9,9-dimethylacridin-2-one (DDAO) measures the activity of beta galactosidase.
Measured: Baseline, Week 1, Week 6
Changes in immunological fitness related to radio-responsiveness and their associated pathological response will be measured by quantifying aging using p16 protein expression as a marker.
The p16 will be quantified by immunofluorescence technique and by flow cytometry.
Measured: Baseline, Week 1, Week 6
Changes in immunological fitness related to radio-responsiveness and their associated pathological response will be measured by quantifying gamma-H2aX (aging).
The markers will be measured using immunofluorescence technique and by flow cytometry.
Measured: Baseline, Week 1, Week 6
Comparing levels of cell death related to radio responsiveness will be measured by quantifying cleaved caspase-3
The markers will be measured using immunofluorescence technique.
Measured: Baseline, Week 1, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start22 May 2023
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (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 Weill Medical College of Cornell UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a molecular characterization trial (MCT) of 25 consecutively treated rectal cancers with short-course radiotherapy (scRT; 25Gy/5 fractions). Tissue and imaging will be collected at three time-points: 1. Baseline (day -28 to 0) - pelvic MRI and CT, research biopsy, blood (50ml), stool. 2. After 5 RT fractions (day 5-10) - CT, research biopsy, blood (50ml), stool 3. At time of surgery (wk 6) - MRI and CT, surgical tumor and nodal specimens, blood (50ml), stool.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Silvia Formenti, M.D., Study chair, Weill Medical College of Cornell UniversityEncouse Golden, M.D., Ph.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943210
- Sponsor's protocol ID
- 22-08025121
- Other IDs
- 1U54CA274291
- Acronym
- ROBIN
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Radiation Oncology-Biology Integration Network (ROBIN) Molecular Characterization Trial (MCT) of Standard Short Course Radiotherapy for Rectal Cancer.
- ClinicalTrials.gov ID
- NCT05943210
- Acronym / sponsor ID
- ROBIN / 22-08025121
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 13 Jul 2023 (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.
This trial (molecular characterization trial) focuses on rectal cancer, a common cancer that is treated with radiotherapy (RT) as standard of care and represents a setting in which to study the effects of RT on the immune system.
Detailed description
The study aims to test the hypothesis that the radiation therapy will assist in targeting the rectal cancer by mounting a robust immune response against the rectal cancer.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a molecular characterization trial (MCT) of 25 consecutively treated rectal cancers with short-course radiotherapy (scRT; 25Gy/5 fractions). Tissue and imaging will be collected at three time-points: 1. Baseline (day -28 to 0) - pelvic MRI and CT, research biopsy, blood (50ml), stool. 2. After 5 RT fractions (day 5-10) - CT, research biopsy, blood (50ml), stool 3. At time of surgery (wk 6) - MRI and CT, surgical tumor and nodal specimens, blood (50ml), stool.
| Arm | Type | Receives |
|---|---|---|
| Single cohort | Other | Radiation: Short Course Radiation Therapy (scRT), Procedure: Total Mesenteric Excision (TME)Eligible patients will receive short course radiation therapy (scRT) of 25Gy over 5 days (fractions) for their localized rectal cancer. Research bloods stool and tissue will be collected at three time points: Baseline, end of radiation therapy and at surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- Age ≥ 18 years
- ECOG performance status 0-1
- cT2-T3N0 or cT1-3N1 or cT4 or cN2
- Rectal cancer amenable to total mesorectal excision
Key exclusion criteria (8 listed)
- Recurrent rectal cancer
- Primary unresectable rectal cancer is defined as a primary rectal tumor which, on the basis of either physical exam or pelvic MRI, is deemed to be adherent or fixed to adjacent pelvic structures (en bloc resection will not be achieved with negative margins).
- Patients who have received prior pelvic radiotherapy
- Patients with prior allogenic stem cell or solid organ transplantation.
- Patients receiving treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor-α agents) administered at >10 mg/day prednisone or equivalent within 2 weeks prior to initiation of study treatment.
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 |
|---|---|---|
| Short Course Radiation Therapy (scRT)Eligible patients will receive short course radiation therapy (scRT) of 25Gy over 5 days (fractions) for their localized rectal cancer. Research bloods stool and tissue will be collected at three time points: Baseline, end of radiation therapy and at surgery. | Radiation | Single cohort |
| Total Mesenteric Excision (TME)Subjects are expected to undergo total mesenteric Excision(TME) even if subjects have achieved complete response by imaging.TME is a specific surgical technique used in the treatment of rectal cancer in which the bowel with the tumor is entirely removed along with surrounding fat and lymph nodes. | Procedure or surgery | Single cohort |
Primary outcome
Number of tissue biopsies obtained from treated patients
Time frame: Baseline
To conduct a multi-centric prospective clinical trial of standard short course RT in the neoadjuvant setting of rectal cancer (MCT), with harmonized tissue acquisition and immune characterization across seven international centers, and assess quality of life during MCT and pathological response at surgery.
Number of tissue biopsies obtained from treated patients
Time frame: Week 1
To conduct a multi-centric prospective clinical trial of standard short course RT in the neoadjuvant setting of rectal cancer (MCT), with harmonized tissue acquisition and immune characterization across seven international centers, and assess quality of life during MCT and pathological response at surgery.
Number of tissue biopsies obtained from treated patients
Time frame: Week 6
To conduct a multi-centric prospective clinical trial of standard short course RT in the neoadjuvant setting of rectal cancer (MCT), with harmonized tissue acquisition and immune characterization across seven international centers, and assess quality of life during MCT and pathological response at surgery.
Number of research specimens obtained before RT.
Time frame: Baseline
To obtain a unique set of biospecimens of optimal quality for cutting-edge imaging and multi-omics analyses at the single cell level that are spatially integrated, obtained longitudinally before and after RT and at the time of surgery.
Number of research specimens obtained after RT.
Time frame: Week 1
To obtain a unique set of biospecimens of optimal quality for cutting-edge imaging and multi-omics analyses at the single cell level that are spatially integrated, obtained longitudinally before and after RT and at the time of surgery.
Number of research specimens obtained at the time of surgery.
Time frame: Week 6
To obtain a unique set of biospecimens of optimal quality for cutting-edge imaging and multi-omics analyses at the single cell level that are spatially integrated, obtained longitudinally before and after RT and at the time of surgery.
13 secondary outcomes
Changes in tumor morphology from pre-treatment and post-treatment MRI will be measured.
Time frame: Baseline, Week 1
Changes in tumor morphology from pre-treatment and post-treatment CT will be measured.
Time frame: Baseline, Week 1
Changes in tumor texture from pre-treatment and post-treatment MRI will be measured.
Time frame: Baseline, Week 1
Changes in tumor texture from pre-treatment and post-treatment CT will be measured.
Time frame: Baseline, Week 1
Changes in enhancement kinetics from pre-treatment and post-treatment MRI will be measured.
Time frame: Baseline, Week 1
Changes in enhancement kinetics from pre-treatment and post-treatment CT will be measured.
Time frame: Baseline, Week 1
Changes in functional diffusion patterns from pre-treatment and post-treatment MRI will be measured.
Time frame: Baseline, Week 1
Changes in functional diffusion patterns from pre-treatment and post-treatment CT will be measured.
Time frame: Baseline, Week 1
Changes in Cellular stress (quantification of reactive Oxygen species (ROS))
Time frame: Baseline, Week 1, Week 6
Changes in immunological fitness related to radio-responsiveness and their associated pathological response will be measured by quantifying senescence using vital dye DDAO.
Time frame: Baseline, Week 1, Week 6
Changes in immunological fitness related to radio-responsiveness and their associated pathological response will be measured by quantifying aging using p16 protein expression as a marker.
Time frame: Baseline, Week 1, Week 6
Changes in immunological fitness related to radio-responsiveness and their associated pathological response will be measured by quantifying gamma-H2aX (aging).
Time frame: Baseline, Week 1, Week 6
Comparing levels of cell death related to radio responsiveness will be measured by quantifying cleaved caspase-3
Time frame: Baseline, Week 1, Week 6
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 15 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Silvia Formenti, M.D. study chair
Weill Medical College of Cornell University
Encouse Golden, M.D., Ph.D. principal investigator
Weill Medical College of Cornell University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Course Radiation Therapy (scRT) and Total Mesenteric Excision (TME) in people with Rectal Cancer, run by Weill Medical College of Cornell University at 5 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 14 inclusion and 8 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 15 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 5 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 Fabiana Gregucci, M.D. (646-962-2199, fgr4002@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of tissue biopsies obtained from treated patients (time frame: Baseline). The study lists 6 primary outcomes in all. 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 15 Jun 2026.