[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100362278":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":45,"responsibleParty":61,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Tata Memorial Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A Or Control Arm- Long course palliative treatment.","ACTIVE_COMPARATOR","Week1: All the patients will receive external sitting of radiation treatment, first fraction of 10 Gy. Week4: All the patients will receive external sitting of radiation treatment, second fraction of 10 Gy. Week7: Patients who have almost complete clinical response will be evaluated for brachytherapy will receive the appropriate brachytherapy procedure depending on the tumor response to a dose of 6-8Gy x 2-3#.The patients who will be found unsuitable for brachytherapy will receive another sitting of external radiation, third fraction of 10 Gy. Week 12: After treatment completion response assessment will be done using following parameters: • Pain assessment using numerical pain rating scale on 0-10 • Vaginal bleeding- yes\u002F no • Vaginal discharge- yes\u002Fno • Analgesic use- WHO ladder and dosing • QOL QC30, QLQC15 Pall, QLQC Cervix 24 • Disease response • Acute toxicity",[13],"Radiation: Long course palliative treatment.",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B or Experimental Arm-Short course palliative radiation.","EXPERIMENTAL","Week 1: Patients in the experimental arm will be treated with short course radiotherapy (25Gy\u002F5#). The dose fractionation of 25 Gy in 5# over a week will be used. Week 4: Patients who have almost complete clinical response will be evaluated for brachytherapy will receive the appropriate brachytherapy procedure depending on the tumor response to a dose of 6-8Gy x 2-3#. The patients who will be found unsuitable for brachytherapy will be kept under observation. Week 12: After treatment completion, response assessment will be done using following parameters: • Pain assessment using numerical pain rating scale on 0-10 • Vaginal bleeding- yes\u002Fno • Vaginal discharge- yes\u002F no • Analgesic use- WHO ladder and dosing • QOL QC30, QLQC15 Pall, QLQC Cervix 24 • Disease response • Acute toxicity. Follow up: Patients follow up will be utilizing standard of care imaging and lab investigations used for the patients. Patients will be evaluated every 3 months for the study duration.",[19],"Radiation: Short course palliative radiation.",[21,26],{"type":22,"name":23,"description":17,"armGroupLabels":24,"otherNames":25},"RADIATION","Short course palliative radiation.",[15],null,{"type":22,"name":27,"description":11,"armGroupLabels":28,"otherNames":25},"Long course palliative treatment.",[9],[30],{"name":31,"affiliation":5,"role":32},"Supriya Sastri","PRINCIPAL_INVESTIGATOR",[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Supriya Chopra","CONTACT","02227405000","5113","supriyasastri@gmail.com",{"name":41,"role":36,"phone":42,"phoneExt":43,"email":44},"TMH Gyn DMG TMC","02224177000","6038","gwg.tmc@gmail.com",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Mumbai","Maharashtra","400012","India","IN",{"type":54,"coordinates":55},"Point",[56,57],72.88261,19.07283,{"lat":57,"lon":56},[60],{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":32,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Supriya Sastri (chopra)","Professor",[65],{"name":66,"class":67},"Tata Memorial Centre","OTHER","100362278","palliative-radiation-for-advanced-cervical-cancer-100362278",false,"NCT03997110","Palliative Radiation for Advanced Cervical Cancer","Rapid Palliation in Locally Advanced Cervical Cancer: A Phase III Randomized Trial","RAPPAL","Inclusion Criteria:\n\n1. Locally advanced cervical cancer (Stage IIIB-IVA) deemed unsuitable for full course radical pelvic radiotherapy or chemoradiation due to the following reasons:\n\n   * Very large volume hard fixed disease infiltrating pelvic wall muscles and ligaments on clinical examination also classified clinically as \"frozen pelvis\" wherein curative intent treatment is not envisaged or feasible.\n   * Fistulous communication between tumour growth and rectum and bladder \\>2x2 cm in size (as judged by cystoscopy for bladder infiltration or clinical or proctosigmoidoscopy examination for rectal\u002Fsigmoid infiltration) wherein radical intent treatment is not intended or feasible and patient is not a candidate for pelvic exenteration.\n   * Deranged renal parameters as measured by Serum Creatinine \\>3 mg\u002Fdl wherein diversion nephrostomy is not planned by the multidisciplinary team due to anticipated poor clinical outcomes.Furthermore concurrence for palliative intent radiotherapy should be corroborated by 2 staff radiation oncologists.\n2. Moderate to Severe Pain on Numerical Rating Score (Score 4 or higher).\n3. Anticipated survival \\\u003C 12 months.\n4. Patients with stage IVB with local disease extent as described in section 1 but systemic chemotherapy is not possible either due to deranged renal function or anticipated poor tolerance.\n\nExclusion Criteria:\n\n1. Patients with distant metastasis needing upfront systemic therapy.\n2. Presence of retroviral disease\n3. Non-compliant for follow up.\n4. Expected survival \\\u003C3 months.","FEMALE","18 Years","75 Years",{"count":80,"type":81},230,"ESTIMATED","INTERVENTIONAL",[84],"NA","The present study is proposed to compare a rapid fractionation schedule of 1 week compared to a protracted schedule of 6-8 weeks for palliation for locally advanced cervical cancer.",[87],"Cervical Cancer",[87,89,90],"Palliative treatment","Radiation Therapy","2026-02-12",{"date":93,"type":94},"2026-02-17","ACTUAL",{"date":96,"type":94},"2020-06-19",{"date":98,"type":81},"2026-08-01",{"name":5,"class":6},1]