[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612839":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":58,"collaborators":25,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":88,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Rajiv Gandhi Cancer Institute & Research Center, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SCRT + Consolidation Chemotherapy","ACTIVE_COMPARATOR","Radiotherapy: 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique.\n\n1. Interval before Chemotherapy: 1-2 weeks after completion of radiotherapy.\n2. Chemotherapy: Modified FOLFOX6 every 2 weeks (total of 12 cycles).",[13],"Radiation: SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique",{"label":15,"type":10,"description":16,"interventionNames":17},"LCRT + Consolidation Chemotherapy","Radiotherapy:\n\n1. Primary tumor and involved nodes: 50 Gy in 25 fractions.\n2. Elective nodal basin: 45 Gy in 25 fractions. Delivered concurrently with oral Capecitabine (825 mg\u002Fm² twice daily on radiotherapy days).",[18],"Radiation: LCRT + Consolidation Chemotherapy",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique","Arm A - SCRT + Consolidation Chemotherapy\n\n1. Radiotherapy: 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique.\n2. Interval before Chemotherapy: 1-2 weeks after completion of radiotherapy.\n3. Chemotherapy: Modified FOLFOX6 every 2 weeks (total of 12 cycles). If the patient is fit, the option of intensifying the chemo to mFOLFIRINOX will be discussed with the patient",[9],null,{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Arm B - LCRT + Consolidation Chemotherapy 1) Radiotherapy: o Primary tumor and involved nodes: 50 Gy in 25 fractions. o Elective nodal basin: 45 Gy in 25 fractions. Delivered concurrently with oral Capecitabine (825 mg\u002Fm² twice daily on radiotherapy days). o Technique: IGRT 2) Interval before Chemotherapy: 1-2 weeks after completion of chemoradiotherapy. 3) Chemotherapy: Modified FOLFOX6",[15],[30],{"name":31,"affiliation":32,"role":33},"Jaskaran Sethi, MD","Rajiv Gandhi Cancer Hospital and Research Centre, New Delhi","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Shivendra Singh, MCh","CONTACT","919818975024","drshivendraonco@gmail.com",[41],{"facility":42,"status":25,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Rajiv Gandhi Cancer Institute and Research Centre","New Delhi","110085","India","IN",{"type":48,"coordinates":49},"Point",[50,51],77.2148,28.62137,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":56,"phoneExt":25,"email":57},"Shaifali Goel, DrNB SG","918368382060","doctor.shaifali@gmail.com",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Shaifali Goel","Consultant, Department of Gastrointestinal and Hepatobiliary services","100612839","short-course-or-long-course-radiotherapy-as-total-neoadjuvant-therapy-in-locally-advanced-rectal-cancer-100612839",false,"NCT07258797","Short Course or Long Course Radiotherapy as Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer","Short Course or Long Course Radiotherapy as Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer : A Prospective, Open Label, Single Institution, Randomized, Parallel Arm Comparative Study","SHOOL","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the rectum\n2. Locally advanced disease based on MRI including cT3-T4 and\u002For node positive disease (cN1 or N2)\n3. Tumor located within 15 cm from the anal verge (confirmed by endoscopy or MRI)\n4. ECOG performance status 0-2\n5. Hemoglobin ≥ 9 g\u002FdL\n6. Absolute neutrophil count ≥ 1,500\u002Fmm³\n7. Platelets ≥ 100,000\u002Fmm³\n8. Total bilirubin ≤ 1.5 × ULN\n9. Aspartate transaminase\u002FAlanine transaminase ≤ 2.5 × ULN\n10. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin\n11. Fit for neoadjuvant therapy and curative resection\n12. Willing and able to provide written, informed consent\n13. Baseline MRI and biopsy (even if done outside) must be reviewed and approved by the institutional radiology and pathology review board, requiring concurrence from two independent pathologists and two independent radiologists\n\nExclusion Criteria:\n\n1. Metastatic disease at presentation (distant nodes, liver, lung, peritoneum, etc.)\n2. Prior pelvic radiotherapy or systemic chemotherapy for rectal cancer\n3. Presence of synchronous malignancies or previous malignancy within 5 years except: Treated basal cell or squamous cell carcinoma of the skin, In situ cervical cancer, Active uncontrolled infection\n4. Known HIV infection with CD4 \\\u003C 200 cells\u002FμL, or active hepatitis B or C\n5. Severe comorbid conditions precluding therapy (e.g., decompensated cardiac, hepatic, or renal disease)\n6. Pregnant or breastfeeding women\n7. Inability to comply with protocol requirements or follow-up schedule\n8. Psychiatric illness or social situations that may limit compliance with study requirements","ALL","18 Years","75 Years",{"count":74,"type":75},150,"ESTIMATED","INTERVENTIONAL",[78],"NA","This study compares two standard radiotherapy approaches (short-course vs. long-course) given before surgery in patients with locally advanced rectal cancer. The goal is to see which treatment is more effective and better tolerated.",[81],"Adenocarcinoma of the Rectum",[83,84,85,86,87],"SHORT COURSE RADIOTHERAPY","LONG COURSE RADIOTHERAPY","RECTAL CANCER","OUTCOMES","SURVIVAL","NOT_YET_RECRUITING","2025-11-20",{"date":91,"type":92},"2025-12-02","ACTUAL",{"date":94,"type":75},"2025-12-01",{"date":96,"type":75},"2029-03-31",{"name":5,"class":6},1]