Nctid:
NCT00002480
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D011471", "term"=>"Prostatic Neoplasms"}], "ancestors"=>[{"id"=>"D005834", "term"=>"Genital Neoplasms, Male"}, {"id"=>"D014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D005832", "term"=>"Genital Diseases, Male"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D011469", "term"=>"Prostatic Diseases"}, {"id"=>"D052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M14335", "name"=>"Prostatic Neoplasms", "asFound"=>"Prostate Cancer", "relevance"=>"HIGH"}, {"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M8946", "name"=>"Genital Neoplasms, Male", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8944", "name"=>"Genital Diseases, Male", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14333", "name"=>"Prostatic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1991-02"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2013-06", "completionDateStruct"=>{"date"=>"2005-08", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-06-24", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-03-10", "lastUpdatePostDateStruct"=>{"date"=>"2013-06-25", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-03-11", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2005-08", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["adenocarcinoma of the prostate", "stage IIB prostate cancer", "stage IIA prostate cancer", "stage III prostate cancer"], "conditions"=>["Prostate Cancer"]}, "referencesModule"=>{"references"=>[{"pmid"=>"7505776", "type"=>"RESULT", "citation"=>"Leibel SA, Heimann R, Kutcher GJ, Zelefsky MJ, Burman CM, Melian E, Orazem JP, Mohan R, LoSasso TJ, Lo YC, et al. Three-dimensional conformal radiation therapy in locally advanced carcinoma of the prostate: preliminary results of a phase I dose-escalation study. Int J Radiat Oncol Biol Phys. 1994 Jan 1;28(1):55-65. doi: 10.1016/0360-3016(94)90141-4."}, {"pmid"=>"7933238", "type"=>"RESULT", "citation"=>"Leibel SA, Zelefsky MJ, Kutcher GJ, Burman CM, Kelson S, Fuks Z. Three-dimensional conformal radiation therapy in localized carcinoma of the prostate: interim report of a phase 1 dose-escalation study. J Urol. 1994 Nov;152(5 Pt 2):1792-8. doi: 10.1016/s0022-5347(17)32387-x."}, {"pmid"=>"7939749", "type"=>"RESULT", "citation"=>"Leibel SA, Zelefsky MJ, Kutcher GJ, Burman CM, Mohan R, Mageras GS, Ling CC, Fuks Z. The biological basis and clinical application of three-dimensional conformal external beam radiation therapy in carcinoma of the prostate. Semin Oncol. 1994 Oct;21(5):580-97. No abstract available."}, {"pmid"=>"8040021", "type"=>"RESULT", "citation"=>"Zelefsky MJ, Leibel SA, Burman CM, Kutcher GJ, Harrison A, Happersett L, Fuks Z. Neoadjuvant hormonal therapy improves the therapeutic ratio in patients with bulky prostatic cancer treated with three-dimensional conformal radiation therapy. Int J Radiat Oncol Biol Phys. 1994 Jul 1;29(4):755-61. doi: 10.1016/0360-3016(94)90563-0."}, {"pmid"=>"9166467", "type"=>"RESULT", "citation"=>"Zelefsky MJ, Leibel SA, Kutcher GJ, Kelson S, Ling CC, Fuks Z. The feasibility of dose escalation with three-dimensional conformal radiotherapy in patients with prostatic carcinoma. Cancer J Sci Am. 1995 Jul-Aug;1(2):142-50."}]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy may be an effective treatment for prostate cancer.\n\nPURPOSE: Phase I trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III prostate cancer.", "detailedDescription"=>"OBJECTIVES: I. Determine the maximum tolerated dose of radiotherapy using 3-dimensional (3D) conformal techniques in patients with stage II or III adenocarcinoma of the prostate. II. Determine the morbidity of high-dose 3D conformal therapy in these patients.\n\nOUTLINE: This is a dose escalation study. Patients undergo 3-dimensional conformal radiotherapy 4-5 days a week for at least 8 weeks. Cohorts of 20-40 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 10% of patients experience dose-limiting toxicity. Patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A minimum of 40 patients will be accrued for this study."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Locally advanced (T2c-T3) adenocarcinoma of the prostate including: Bulky tumors confined to prostate (stage II) Tumors extending beyond capsule (stage III) PSA no greater than 20 ng/mL No regional lymph node involvement (by CT scan or surgical sampling) No distant metastases\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 11 g/dL Hepatic: Not specified Renal: Not specified Other: No major medical or psychiatric illness that would preclude study No metallic pelvic prosthesis\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: No prior radiotherapy (including pelvic irradiation) Surgery: No prior radical surgery for carcinoma of the prostate"}, "identificationModule"=>{"nctId"=>"NCT00002480", "briefTitle"=>"Radiation Therapy in Treating Patients With Prostate Cancer", "organization"=>{"class"=>"OTHER", "fullName"=>"Memorial Sloan Kettering Cancer Center"}, "officialTitle"=>"Phase I Study of 3-Dimensional Conformal Radiotherapy in Patients With Locally Advanced (Stage T2c and T3) Adenocarcinoma of the Prostate", "orgStudyIdInfo"=>{"id"=>"91-022"}, "secondaryIdInfos"=>[{"id"=>"CDR0000077099", "type"=>"REGISTRY", "domain"=>"PDQ (Physician Data Query)"}, {"id"=>"NCI-V91-0102"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"radiation therapy", "type"=>"RADIATION"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Memorial Sloan-Kettering Cancer Center", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}], "overallOfficials"=>[{"name"=>"Michael J. Zelefsky, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Memorial Sloan Kettering Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Memorial Sloan Kettering Cancer Center", "class"=>"OTHER"}}}}
