[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT01185132":3,"trial-entities:NCT01185132":193,"trial-summary:NCT01185132":198},{"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":17,"conditions":18,"keywords":20,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":37,"interventions":40,"primary_outcomes":53,"secondary_outcomes":61,"sex":86,"minimum_age":87,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":88,"std_ages":108,"locations":111,"central_contacts":177,"overall_officials":185,"references":187,"see_also_links":192},"NCT01185132","2009-APBI","Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy","A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy","RECRUITING","2028-07","2014-06","2014-06-26","2009-07","Rocky Mountain Cancer Centers","OTHER",false,"In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.",null,[19],"Breast Cancer",[21,22,23,24,25,26,27,28,29,30,31,32],"breast-conservation","adjuvant radiotherapy","breast cancer","early-stage breast cancer","DCIS","lumpectomy","accelerated partial breast irradiation","APBI","three dimensional conformal external radiotherapy","intensity modulated radiotherapy","3D CRT","IMRT","INTERVENTIONAL","TREATMENT",[36],"PHASE3",{"count":38,"type":39},660,"ESTIMATED",[41,49],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":47},"RADIATION","accelerated partial breast irradiation - 3D-conformal planning","38.5 Gy, 10 fractions over 5 days",[46],"3D-CRT",[28,48],"EBRT",{"type":42,"name":50,"description":44,"armGroupLabels":51,"otherNames":52},"accelerated partial breast irradiation - IMRT planning",[32],[28,48],[54,58],{"measure":55,"description":56,"timeFrame":57},"Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)","Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit","5 years",{"measure":59,"description":56,"timeFrame":60},"Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)","2-5 years",[62,66,70,73,77,80,83],{"measure":63,"description":64,"timeFrame":65},"Dosimetric comparison","Comparison of treatment plans and actual doses received between comparable patients treated with 3D-CRT and IMRT with regard to treatment target and normal tissue","5-10 days",{"measure":67,"description":68,"timeFrame":69},"Acute skin reactions","Radiation-induced dermatitis","6 months",{"measure":71,"description":72,"timeFrame":60},"Cosmetic outcomes after APBI","Assesed by both treating investigators and subjective patient questionnaires filled out at each follow-up visit",{"measure":74,"description":75,"timeFrame":76},"Ipsilateral breast event","Track occurrence and patterns of local treatment failures or new primaries within the treated breast (efficacy outcome measure)","5-15 years",{"measure":78,"description":79,"timeFrame":76},"Cause specific survival","Track survival status and the specific cause(s) of death if applicable for study participants (efficacy outcome measure)",{"measure":81,"description":82,"timeFrame":76},"Disease free survival","Track breast-cancer free survival status of study participants (efficacy outcome measure)",{"measure":84,"description":85,"timeFrame":76},"Overall survival","Track the overall survival status of all study participants (efficacy outcome measure)","ALL","40 Years",{"inclusion":89,"exclusion":101,"raw_text":107},[90,91,92,93,94,95,96,97,98,99,100],"Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M0.","Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.","Negative surgical margins ( ≥ 0.2 cm) after final surgery.","Subjects with infiltrating lobular histologies or high nuclear grade DCIS will be required to have breast MRI scanning as part of the initial staging to verify localized disease.","Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy.","Findings on MRI scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric\u002Fmultifocal disease.","Subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications.","Willing to complete additional screening requirements and meet eligibility criteria as defined in protocol Sec. 4.4.","Successful placement of fiducial markers for IGRT requiring nonmigrating fiducials.","PTV to ipsilateral breast ratio (IBR) ≤ 25 %.","Radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.",[102,103,104,105,106],"Pregnancy or breast-feeding.","Have collagen-vascular disease.","Inadequate surgical margins ( \\\u003C 0.2 cm) after final surgery.","Subjects with persistent malignant\u002Fsuspicious micro-calcifications.","Gross multifocal disease and microscopic disease greater than 3.0 cm.","Inclusion Criteria:\n\n* Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M0.\n* Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.\n* Negative surgical margins ( ≥ 0.2 cm) after final surgery.\n* Subjects with infiltrating lobular histologies or high nuclear grade DCIS will be required to have breast MRI scanning as part of the initial staging to verify localized disease.\n* Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy.\n* Findings on MRI scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric\u002Fmultifocal disease.\n* Subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications.\n* Willing to complete additional screening requirements and meet eligibility criteria as defined in protocol Sec. 4.4.\n* Successful placement of fiducial markers for IGRT requiring nonmigrating fiducials.\n* PTV to ipsilateral breast ratio (IBR) ≤ 25 %.\n* Radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.\n\nExclusion Criteria:\n\n* Pregnancy or breast-feeding.\n* Have collagen-vascular disease.\n* Inadequate surgical margins ( \\\u003C 0.2 cm) after final surgery.\n* Subjects with persistent malignant\u002Fsuspicious micro-calcifications.\n* Gross multifocal disease and microscopic disease greater than 3.0 cm.",[109,110],"ADULT","OLDER_ADULT",[112,129,143,155,165],{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":117,"contacts":118,"geoPoint":126},"Rocky Mountain Cancer Centers - Aurora","Aurora","Colorado","80012","United States",[119,122,124],{"name":120,"role":121},"Dennis Carter, MD","SUB_INVESTIGATOR",{"name":123,"role":121},"William Daniel, MD",{"name":125,"role":121},"Kathryn Howell, MD",{"lat":127,"lon":128},39.72943,-104.83192,{"facility":130,"status":8,"city":131,"state":115,"zip":132,"country":117,"contacts":133,"geoPoint":140},"Rocky Mountain Cancer Centers - Boulder","Boulder","80303",[134,136,138],{"name":135,"role":121},"Andrew Antell, MD",{"name":137,"role":121},"Meera Patel, MD",{"name":139,"role":121},"Ralph Wright, MD",{"lat":141,"lon":142},40.01499,-105.27055,{"facility":144,"status":8,"city":145,"state":115,"zip":146,"country":117,"contacts":147,"geoPoint":152},"Rocky Mountain Cancer Centers - Lakewood","Lakewood","80228",[148,149],{"name":139,"role":121},{"name":150,"role":151},"Charles Leonard, MD","PRINCIPAL_INVESTIGATOR",{"lat":153,"lon":154},39.70471,-105.08137,{"facility":156,"status":8,"city":157,"state":115,"zip":158,"country":117,"contacts":159,"geoPoint":162},"Rocky Mountain Cancer Centers - Littleton","Littleton","80120",[160,161],{"name":150,"role":151},{"name":125,"role":121},{"lat":163,"lon":164},39.61332,-105.01665,{"facility":166,"status":8,"city":167,"state":115,"zip":168,"country":117,"contacts":169,"geoPoint":174},"Rocky Mountain Cancer Centers - Thornton","Thornton","80260",[170,172],{"name":171,"role":121},"Robert LaPorte, MD",{"name":173,"role":121},"Daniel Chin, MD",{"lat":175,"lon":176},39.86804,-104.97192,[178,183],{"name":179,"role":180,"phone":181,"email":182},"Rachel Lei, BS","CONTACT","303-418-7607","rachel.lei@usoncology.com",{"name":150,"role":180,"phone":184},"303-730-4700",[186],{"name":150,"affiliation":13,"role":151},[188],{"pmid":189,"type":190,"citation":191},"34469056","DERIVED","Leonard CE, Wang Y, Asmar L, Lei RY, Howell KT, Henkenberns PL, Johnson TK, Hobart TL, Tole SP, Kercher JM, Widner JL, Barke L, Kaske T, Carter DL. A prospective Phase III trial evaluating patient self-reported pain and cosmesis in accelerated partial breast irradiation utilizing 3-D versus intensity-modulated radiotherapy. Cancer Med. 2021 Oct;10(20):7089-7100. doi: 10.1002\u002Fcam4.4242. Epub 2021 Sep 1.",[],{"nct_id":4,"conditions":194,"biomarkers":197},[195,196],"Breast Carcinoma","Breast Ductal Carcinoma In Situ",[],{"nct_id":4,"found":199,"summary":200,"prompt_version":210},true,{"design":201,"status":202,"heading":203,"summary":204,"follow_up":205,"word_count":206,"commitments":207,"compensation":208,"drugs_mentioned":209},"This interventional study plans to enroll 660 participants to compare two radiation treatments. It is not specified if it is randomized or blinded.","completed","IMRT vs. 3D-conformal APBI for Early Stage Breast Cancer","This study is comparing two types of radiation therapy for early-stage breast cancer after a lumpectomy (surgery to remove a tumor while saving the breast). It's looking at Intensity Modulated Radiotherapy (IMRT) and 3D-conformal Accelerated Partial Breast Irradiation (APBI). Both treatments deliver 38.5 Gy of radiation in 10 sessions over 5 days. Researchers want to see if IMRT, which may spare more healthy tissue, leads to less breast or chest wall pain compared to 3D-conformal APBI. You might be able to join if you are at least 40 years old, have early-stage breast cancer (Tis, T1, T2 up to 3.0 cm, N0, M0), and have clear surgical margins (at least 0.2 cm). The study aims to enroll 660 participants.","Participants will be followed for breast pain for up to 5 years and for chest wall pain for 2 to 5 years after treatment.",119,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]