[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06637462":3,"trial-entities:NCT06637462":139,"trial-summary:NCT06637462":145},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":15,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":62,"locations":65,"central_contacts":125,"overall_officials":132,"references":135,"see_also_links":136},"NCT06637462","24-238","A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer","DISCRN in Rectal Cancer: DISseCting Response to Neoadjuvant Therapy in Rectal Cancer","RECRUITING","2027-10-09","2026-05","2026-06-02","2024-10-09","Memorial Sloan Kettering Cancer Center","OTHER",null,"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.",[18,19],"Rectal Cancer","Adenocarcinoma of the Rectum",[21,22,13,5],"rectal cancer","adenocarcinoma of the rectum","INTERVENTIONAL","DIAGNOSTIC",[26],"NA",{"count":28,"type":29},60,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DIAGNOSTIC_TEST","Endoscopy","Standard of care endoscopy",[36],"Participants with Rectal Cancer",[38],{"measure":39,"description":40,"timeFrame":41},"Clinical response","To define endoscopic (clinical) response to neoadjuvant therapy at the following time points using the MSK regression schema","Up to 3 years",[],"ALL","18 Years",false,{"inclusion":47,"exclusion":54,"raw_text":61},[48,49,50,51,52,53],"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.",[55,56,57,58,59,60],"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.","Inclusion Criteria:\n\n* 18 years of age or older on day of signing informed consent.\n* Have a histologically confirmed diagnosis of invasive adenocarcinoma of the rectum with no known mismatch repair deficiency or Her2 amplification.\n* Eligible for and plan to initiate standard-of-care therapy with any of the following regimens:\n\n  * Induction fluoropyrimidine (capecitabine \\[preferred\\] or 5-FU) based chemoradiation\n  * With plan for consolidative CAPEOX, FOLFOX, or FOLIRINOX\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* Patients with prior external beam radiation therapy to the pelvis or brachytherapy seed implantation of the prostate.\n* Patients who are pregnant or breastfeeding.\n* Men or women not using effective contraception.\n* Patients with a contraindication to MR imaging.\n* Patients on blood thinners prohibiting endoluminal tumor biopsies.",[63,64],"ADULT","OLDER_ADULT",[66,80,89,99,108,116],{"facility":67,"status":8,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":77},"Memorial Sloan Kettering Monmouth (Limited protocol activities)","Middletown","New Jersey","07748","United States",[73],{"name":74,"role":75,"phone":76},"Paul Romesser, MD","CONTACT","646-888-2118",{"lat":78,"lon":79},40.39428,-74.11709,{"facility":81,"status":8,"city":82,"state":69,"zip":83,"country":71,"contacts":84,"geoPoint":86},"Memorial Sloan Kettering Bergen (Limited protocol activities)","Montvale","07645",[85],{"name":74,"role":75,"phone":76},{"lat":87,"lon":88},41.04676,-74.02292,{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":71,"contacts":94,"geoPoint":96},"Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)","Commack","New York","11725",[95],{"name":74,"role":75,"phone":76},{"lat":97,"lon":98},40.84288,-73.29289,{"facility":100,"status":8,"city":101,"state":92,"zip":102,"country":71,"contacts":103,"geoPoint":105},"Memorial Sloan Kettering Westchester (Limited protocol activities)","Harrison","10604",[104],{"name":74,"role":75,"phone":76},{"lat":106,"lon":107},40.96899,-73.71263,{"facility":109,"status":8,"city":92,"state":92,"zip":110,"country":71,"contacts":111,"geoPoint":113},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",[112],{"name":74,"role":75,"phone":76},{"lat":114,"lon":115},40.71427,-74.00597,{"facility":117,"status":8,"city":118,"state":92,"zip":119,"country":71,"contacts":120,"geoPoint":122},"Memorial Sloan Kettering Nassau (Limited protocol activities)","Rockville Centre","11553",[121],{"name":74,"role":75,"phone":76},{"lat":123,"lon":124},40.65871,-73.64124,[126,128],{"name":74,"role":75,"phone":76,"email":127},"romessep@mskcc.org",{"name":129,"role":75,"phone":130,"email":131},"Andrea Cercek, MD","646-888-4189","cerceka@mskcc.org",[133],{"name":74,"affiliation":13,"role":134},"PRINCIPAL_INVESTIGATOR",[],[137],{"label":13,"url":138},"http:\u002F\u002Fwww.mskcc.org",{"nct_id":4,"conditions":140,"biomarkers":142},[141],"Rectal Carcinoma",[143,144],"ERBB2 Gene","MRC1 wt Allele",{"nct_id":4,"found":146,"summary":147,"prompt_version":157},true,{"design":148,"status":149,"heading":150,"summary":151,"follow_up":152,"word_count":153,"commitments":154,"compensation":155,"drugs_mentioned":156},"This is an interventional study planning to enroll 60 participants. It is designed to observe how individuals respond to standard treatments for rectal cancer.","completed","Study of Standard Treatment for Rectal Cancer","This study is looking at how people with rectal cancer respond to standard treatments like chemoradiation and chemotherapy before surgery. Researchers want to understand if testing your blood, tissue, and scans can help predict if your cancer will improve, worsen, or stay the same after treatment. You might be able to join if you are 18 or older, have been diagnosed with invasive adenocarcinoma of the rectum, and do not have certain genetic markers (mismatch repair deficiency or Her2 amplification). You must also be planning to start standard treatments like fluoropyrimidine (capecitabine or 5-FU). The main goal is to see your clinical response to treatment, which will be checked for up to 3 years. The study is currently unclear on its recruitment status.","Your clinical response will be measured for up to 3 years after treatment.",123,"You would undergo standard-of-care endoscopy and provide blood and tissue samples for testing. The study will also use results from your scans to understand treatment response.","Not stated in the trial record.",[],"v2"]