[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectum-cancer-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectum-cancer-adenocarcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100609936","phase-1-adaptive-radiation-boost-for-rectal-cancer-100609936",false,"NCT07221058","Adaptive Radiation Boost for Rectal Cancer","Adaptive Radiation BOost for Rectal Cancer: a Phase I Dose Escalation Study (ARBOR)","ARBOR","Inclusion Criteria:\n\n1. Subjects must have histologically or cytologically confirmed rectal adenocarcinoma.\n2. Subjects must have T2-3, N0-1, M0 rectal cancer. Staging will be done by MRI pelvis and CT chest and abdomen with contrast. PET-CT will be an acceptable alternative for the CT chest and abdomen.\n3. Subjects must be willing to undergo MRI scans.\n4. Age ≥18 years.\n5. ECOG performance status 0 or 1.\n6. Estimated survival of ≥ 12 months.\n7. Subjects must have normal organ and marrow function as defined below\n\n   * Absolute neutrophil count \\> =1,000\u002FmcL\n   * Platelets \\>= 75,000\u002FmcL\n   * Total bilirubin \\\u003C 3 mg\u002FdL\n8. Subjects must be able to tolerate the chemotherapy regimens outlined in the treatment plan (Section 5.0), both before and after ART.\n\n   * Before ART: Capecitabine at a dose of 825 mg\u002Fm²\n   * After ART: FOLFOX combination chemotherapy, or 5-FU, or capecitabine\n9. Subjects must possess the ability to understand and willingness to sign a written informed consent and HIPAA consent document. Translation services including translation of informed consent documents will be provided, as feasible, to encourage diversity of inclusion of eligible patients.\n\nExclusion Criteria:\n\n1. Subjects who have been previously treated for rectal cancer are excluded.\n2. Subjects with rectal cancer involving the anal canal are excluded. (Rectal cancer abutting the anal canal will be allowed.)\n3. Subjects must not be receiving any other investigational agents.\n4. Subjects may not have had prior pelvic radiation.\n5. Subjects should not have had a cancer actively treated within the last 3 years, excluding non-melanoma skin cancer.\n6. Subjects must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Any condition or significant co-morbidity that prevents safe delivery of ART per the discretion of the treating physician(s).\n8. Subjects must not be pregnant or breast-feeding.","ALL","18 Years",{"count":20,"type":21},37,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical trial is to find out if giving extra adaptive radiation therapy after standard chemoradiation treatment is safe and helpful for people with rectal cancer.\n\nThe main questions the study aims to answer are:\n\n* Can this approach help target the most aggressive cancer cells more accurately, while protecting nearby healthy tissue?\n* Can it reduce the side effects that people may experience during treatment?\n\nParticipants will:\n\n* First receive standard treatment: radiation (45 Gy in 25 sessions) along with a chemotherapy pill called capecitabine.\n* Then get extra radiation using MRI scans every two weeks to adjust the treatment based on how the tumor responds.\n* Use a small balloon during treatment to help aim the radiation and protect healthy areas.\n* Finally, receive additional chemotherapy (such as FOLFOX) for four months.",[27],"Rectum Cancer, Adenocarcinoma",[29,30,31,32,33],"Adaptive Radiation Therapy","Rectum Cancer","Adenocarcinoma","Organ Preservation","Total Mesorectal Excision","RECRUITING","2025-12-02",{"date":37,"type":38},"2025-12-09","ACTUAL",{"date":40,"type":38},"2025-10-24",{"date":42,"type":21},"2029-11-01",{"name":44,"class":45},"Fox Chase Cancer Center","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":46},"100601273","adar1-expression-level-in-rectal-cancer-100601273","NCT07108348","ADAR1 Expression Level in Rectal Cancer","The Effect of ADAR1 Expression Level on Total Neoadjuvant Treatment Response in Locally Advanced Rectal Cancer","ADAR1TNT","Inclusion Criteria:\n\n* Histological and staging diagnosis of local\u002Flocally advanced rectal cancer\n* ECOG performance score between 0 and 2\n* No contraindications for chemotherapy (CT) and\u002For radiotherapy (RT)\n\nExclusion Criteria:\n\n* Those diagnosed with metastatic rectal cancer\n* Those suspected of having rectal cancer or patients with a diagnosis of a second primary cancer\n* Those who have not signed the informed consent form\n* Those with contraindications for chemotherapy (CT) and\u002For radiation therapy (RT)","90 Years",{"count":57,"type":21},50,"12 Months","OBSERVATIONAL","Total neoadjuvant therapy (TNT) is currently the standard treatment for locally\u002Flocally advanced rectal cancer due to better response and fewer distant metastases. In TNT, sequential chemotherapy (CT) and chemoradiotherapy (CRT) are planned and depending on the treatment response, either surgery is performed or a watch and wait approach is applied. Depending on tumor localization and patient performance status, CT is planned as induction or consolidation. Most of the time, mFOLFOX6 and CAPOX are preferred as CT regimen. In proximal rectal cancer, surgery can be performed without CRT and only after CT. In locally\u002Flocally advanced rectal cancer, the aim is to avoid surgery as much as possible or to perform sphincter-sparing surgery if possible. Colonoscopy and pelvic MR at the time of diagnosis are the most important steps in staging, treatment selection and decision making. These two diagnostic methods should be repeated especially for watch and wait decision and for response evaluation after TNT.\n\nADAR 1 (Adenosine deaminase acting on RNA1) is an RNA editing enzyme that catalyzes the deamination of adenosine to inosine (A-to-I), a dynamic modification that can lead to a diverse transcriptome in a combinatorial manner. A defect in ADAR1-mediated RNA modification results in abnormal regulation of substrates that can affect phenotypic changes in cancer. This phenomenon of over-regulation is seen in many cancers such as colon, liver, lung, breast and esophageal cancers and in many cases promotes tumor progression. In studies, increased ADAR1 expression has been associated with lower survival and worse prognosis, especially in metastatic colon and gastric cancer. ADAR1 is also predicted to increase proliferation through both the AKT pathway and the mTOR pathway and therefore may be targeted in the near future.\n\nADAR1 expression is monitored by RNA-based real time PCR. In order to demonstrate increased expression, biopsies should be taken from the malignant tissue and the intact tissue of the patient and the biopsy should be stored under -80 C conditions immediately after biopsy to prevent RNA degradation. The tissue will not come into contact with nitrogen or formaldehyde.\n\nIn this study, sufficient biopsies from cancerous and intact tissue will be taken from patients with suspected rectal cancer, confirmed by pelvic MRI and consent for participation in the study, and fresh tissue will be stored at -80 C in the genetics laboratory. After the TNT plan is made by the investigators and the treatment is completed, both pelvic MRI and control rectoscopy will be performed for preoperative evaluation. Again, biopsies will be taken from diseased and healthy tissue and ADAR1 expression will be evaluated. The study is planned to include 50 participants and a period of one year is foreseen for tissue procurement\u002Fstorage.\n\nThe investigators' aim in this study will be to determine whether ADAR1 expression level changes after TNT, whether this predicts clinical and pathological response, whether responses change according to the selected CT, whether there is a difference between CT induction-consolidation\u002FRT short or long course, and the relationship between tumor DNA mismatch repair enzyme status and ADAR1 level. The investigators primary endpoint will be the effect of the change in ADAR1 expression level on the response after TNT (ORR). Secondary endpoints will be quality of life, recurrence-free survival (RFS) and overall survival (OS).",[27],[63,64,65],"ADAR1","rectum cancer","TNT","2025-08-04",{"date":68,"type":38},"2025-08-07",{"date":70,"type":38},"2025-06-01",{"date":72,"type":21},"2026-09-01",{"name":74,"class":45},"Necmettin Erbakan University"]