دورية أكاديمية
أعرض في EDS

Alliance for clinical trials in oncology (ALLIANCE) trial A021501: preoperative extended chemotherapy vs. chemotherapy plus hypofractionated radiation therapy for borderline resectable adenocarcinoma of the head of the pancreas.

التفاصيل البيبلوغرافية
العنوان: Alliance for clinical trials in oncology (ALLIANCE) trial A021501: preoperative extended chemotherapy vs. chemotherapy plus hypofractionated radiation therapy for borderline resectable adenocarcinoma of the head of the pancreas.
المؤلفون: Katz MHG; The University of Texas MD Anderson Cancer Center, University of Texas, 1400 Pressler Street FCT 17.6058, Unit #1484, Houston, TX, 77030-4009, USA. mhgkatz@mdanderson.org., Ou FS; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA., Herman JM; The University of Texas MD Anderson Cancer Center, University of Texas, 1400 Pressler Street FCT 17.6058, Unit #1484, Houston, TX, 77030-4009, USA., Ahmad SA; University of Cincinnati, Cincinnati, OH, USA., Wolpin B; Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA., Marsh R; NorthShore Evanston Hospital, Evanston, IL, USA., Behr S; The University of California at San Francisco, San Francisco, CA, USA., Shi Q; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA., Chuong M; University of Maryland/Greenebaum Cancer Center, Baltimore, MD, USA., Schwartz LH; New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA., Frankel W; The Ohio State University, Columbus, OH, USA., Collisson E; The University of California at San Francisco, San Francisco, CA, USA., Koay EJ; The University of Texas MD Anderson Cancer Center, University of Texas, 1400 Pressler Street FCT 17.6058, Unit #1484, Houston, TX, 77030-4009, USA., Hubbard JM; Mayo Clinic, Rochester, MN, USA., Leenstra JL; Mayo Clinic, Rochester, MN, USA., Meyerhardt J; Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA., O'Reilly E; Memorial Sloan Kettering Cancer Center, New York, NY, USA.
مؤلفون مشاركون: Alliance for Clinical Trials on Oncology
المصدر: BMC cancer [BMC Cancer] 2017 Jul 27; Vol. 17 (1), pp. 505. Date of Electronic Publication: 2017 Jul 27.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 100967800 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2407 (Electronic) Linking ISSN: 14712407 NLM ISO Abbreviation: BMC Cancer Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : BioMed Central, [2001-
مواضيع طبية MeSH: Adenocarcinoma/*therapy , Antineoplastic Combined Chemotherapy Protocols/*therapeutic use , Pancreatic Neoplasms/*therapy, Camptothecin/administration & dosage ; Camptothecin/analogs & derivatives ; Clinical Trials, Phase II as Topic ; Combined Modality Therapy ; Fluorouracil/administration & dosage ; Humans ; Irinotecan ; Leucovorin/administration & dosage ; Multicenter Studies as Topic ; Organoplatinum Compounds/administration & dosage ; Oxaliplatin ; Pancreatectomy ; Radiation Dose Hypofractionation ; Randomized Controlled Trials as Topic
مستخلص: Background: Borderline resectable pancreatic cancers infiltrate into adjacent vascular structures to an extent that makes an R0 resection unlikely when pancreatectomy is performed de novo. In a pilot study, Alliance for Clinical Trials in Oncology Trial A021101, the median survival of patients who received chemotherapy and radiation prior to anticipated pancreatectomy was 22 months, and 64% of operations achieved an R0 resection. However, the individual contributions of preoperative chemotherapy and radiation therapy to therapeutic outcome remain poorly defined.
Methods: In Alliance for Clinical Oncology Trial A021501, a recently activated randomized phase II trial, patients (N = 134) with a CT or MRI showing a biopsy-confirmed pancreatic ductal adenocarcinoma that meets centrally-reviewed anatomic criteria for borderline resectable disease will be randomized to receive either 8 cycles of modified FOLFIRINOX (oxaliplatin 85 mg/m 2 , irinotecan 180 mg/m 2 , leucovorin 400 mg/m 2 and infusional 5-fluorouracil 2400 mg/m 2 over 2 days for 4 cycles) or to 7 cycles of modified FOLFIRINOX followed by stereotactic body radiation therapy (33-40 Gy in 5 fractions). Patients without evidence of disease progression following preoperative therapy will undergo pancreatectomy and will subsequently receive 4 cycles of postoperative modified FOLFOX6 (oxaliplatin 85 mg/m 2 , leucovorin 400 mg/m 2 , bolus 5-fluorouracil 400 mg/m 2 , and infusional 5-fluorouracil 2400 mg/m 2 over 2 days for 4 cycles). The primary endpoint is the 18-month overall survival rate of patients enrolled into each of the two treatment arms. An interim analysis of the R0 resection rate within each arm will be conducted to assess treatment futility after accrual of 30 patients. Secondary endpoints include rates of margin-negative resection and event-free survival. The primary analysis will compare the 18-month overall survival rate of each arm to a historical control rate of 50%. The trial is activated nationwide and eligible to be opened for accrual at any National Clinical Trials Network cooperative group member site.
Discussion: This study will help define standard preoperative treatment regimens for borderline resectable pancreatic cancer and position the superior arm for further evaluation in future phase III trials.
Trial Registration: ClinicalTrials.gov : NCT02839343 , registered July 14, 2016.
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معلومات مُعتمدة: U10 CA032291 United States CA NCI NIH HHS; U10 CA180821 United States CA NCI NIH HHS; U10 CA180858 United States CA NCI NIH HHS; U10 CA180882 United States CA NCI NIH HHS; P30 CA016058 United States CA NCI NIH HHS; U10 CA180867 United States CA NCI NIH HHS
فهرسة مساهمة: Keywords: Borderline resectable; Chemotherapy; Clinical trial; Pancreatic cancer; Pancreatoduodenectomy; Radiation; Stereotactic
سلسلة جزيئية: ClinicalTrials.gov NCT02839343
المشرفين على المادة: 0 (Organoplatinum Compounds)
04ZR38536J (Oxaliplatin)
7673326042 (Irinotecan)
Q573I9DVLP (Leucovorin)
U3P01618RT (Fluorouracil)
XT3Z54Z28A (Camptothecin)
تواريخ الأحداث: Date Created: 20170729 Date Completed: 20180418 Latest Revision: 20240326
رمز التحديث: 20240326
مُعرف محوري في PubMed: PMC5530569
DOI: 10.1186/s12885-017-3441-z
PMID: 28750659
قاعدة البيانات: MEDLINE
الوصف
تدمد:1471-2407
DOI:10.1186/s12885-017-3441-z