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Keywords {🔍}

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Topics {✒️}

decrease dna damage term=nct03503630&draw=2&rank=1 disease-free survival neo-adjuvant chemotherapy dna mismatch repair article download pdf gov/ct2/show/nct03503630 full access national cancer institute phase ii trial correlate pd-l1 expression expected sample size anti-cytotoxic t-lymphocyte recurrent rectal cancer locoregional rectal cancer colorectal cancer total sample size disease-free pathologic response rate single-dose radiotherapy induces immune-mediated abscopal effect long-term results biometric research branch concurrent pd-l1 blockade privacy choices/manage cookies mismatch-repair deficiency rectal adenocarcinoma tala al awabdeh mahmoud al masri clinical cancer genetics neoadjuvant response prediction programmed death-ligand 1 pelvis ct scan immune checkpoint inhibitor pathologic complete response major pathologic response total neoadjuvant therapy enhance tumor immunotherapy enlarged lymph nodes international public registry globally accepted standards cell immune response chemoradiotherapy improves survival immune-mediated inhibition pathologic response data clinical complete response rectal cancer total mesorectal excision creative commons licence independent ethics committee

Questions {❓}

• Gov/ct2/show/NCT03503630?

Schema {🗺️}

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         headline:Efficacy and safety-in analysis of short-course radiation followed by mFOLFOX-6 plus avelumab for locally advanced rectal adenocarcinoma
         description:Neoadjuvant chemotherapy and short-course radiotherapy followed by resection has been gaining recognition in the treatment of rectal cancer. Avelumab is a fully human immunoglobulin that binds Programmed Death-Ligand 1 (PD-L1) and prevents the suppression of the cytotoxic T cell immune response. This phase II trial evaluates the safety and pathologic response rate of short-course radiation followed by 6 cycles of mFOLFOX6 with avelumab in patients with locally advanced rectal cancer (LARC). This study is prospective single-arm, multicenter phase II trial adopting Simon’s two-stage. Short-course radiation is given over 5 fractions to a total dose of 25 Gy. mFOLFOX6 plus avelumab (10 mg/kg) are given every 2 weeks for 6 cycles. Total mesorectal excision is performed 3–4 weeks after the last cycle of avelumab. Follow up after surgery is done every 3 months to a total of 36 months. Adverse event data collection is recorded at every visit. 13 out of 44 patients with LARC were enrolled in the first stage of the study (30% from total sample size). All patients met the inclusion criteria and received the full short-course radiation course followed by 6 cycles of mFOLFOX6 plus avelumab. 12 out of the 13 patients completed TME while one patient had progression of disease and was dropped out of the study. The sample consisted of 9 (69%) males and 4 (31%) females with median age of 62 (33–73) years. The first interim analysis revealed that 3 (25%) patients achieved pathologic complete response (pCR) (tumor regression grade, TRG 0) out of 12. While 3 (25%) patients had near pCR with TRG 1. In total, 6 out of 12 patients (50%) had a major pathologic response. All patients were found to be MMR proficient. The protocol regimen was well tolerated with no serious adverse events of grade 4 reported. In patients with LARC, neoadjuvant radiation followed by mFOLFOX6 with avelumab is safe with a promising pathologic response rate. Trial Registration Number and Date of Registration ClinicalTrials.gov NCT03503630, April 20, 2018. https://clinicaltrials.gov/ct2/show/NCT03503630?term=NCT03503630&draw=2&rank=1 .
         datePublished:2020-10-07T00:00:00Z
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            Rectal cancer
            Radiotherapy
            Chemotherapy
            Immunotherapy
            Neo-adjuvant therapy
            Cancer Research
            Oncology
            Imaging / Radiology
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      headline:Efficacy and safety-in analysis of short-course radiation followed by mFOLFOX-6 plus avelumab for locally advanced rectal adenocarcinoma
      description:Neoadjuvant chemotherapy and short-course radiotherapy followed by resection has been gaining recognition in the treatment of rectal cancer. Avelumab is a fully human immunoglobulin that binds Programmed Death-Ligand 1 (PD-L1) and prevents the suppression of the cytotoxic T cell immune response. This phase II trial evaluates the safety and pathologic response rate of short-course radiation followed by 6 cycles of mFOLFOX6 with avelumab in patients with locally advanced rectal cancer (LARC). This study is prospective single-arm, multicenter phase II trial adopting Simon’s two-stage. Short-course radiation is given over 5 fractions to a total dose of 25 Gy. mFOLFOX6 plus avelumab (10 mg/kg) are given every 2 weeks for 6 cycles. Total mesorectal excision is performed 3–4 weeks after the last cycle of avelumab. Follow up after surgery is done every 3 months to a total of 36 months. Adverse event data collection is recorded at every visit. 13 out of 44 patients with LARC were enrolled in the first stage of the study (30% from total sample size). All patients met the inclusion criteria and received the full short-course radiation course followed by 6 cycles of mFOLFOX6 plus avelumab. 12 out of the 13 patients completed TME while one patient had progression of disease and was dropped out of the study. The sample consisted of 9 (69%) males and 4 (31%) females with median age of 62 (33–73) years. The first interim analysis revealed that 3 (25%) patients achieved pathologic complete response (pCR) (tumor regression grade, TRG 0) out of 12. While 3 (25%) patients had near pCR with TRG 1. In total, 6 out of 12 patients (50%) had a major pathologic response. All patients were found to be MMR proficient. The protocol regimen was well tolerated with no serious adverse events of grade 4 reported. In patients with LARC, neoadjuvant radiation followed by mFOLFOX6 with avelumab is safe with a promising pathologic response rate. Trial Registration Number and Date of Registration ClinicalTrials.gov NCT03503630, April 20, 2018. https://clinicaltrials.gov/ct2/show/NCT03503630?term=NCT03503630&draw=2&rank=1 .
      datePublished:2020-10-07T00:00:00Z
      dateModified:2020-10-07T00:00:00Z
      pageStart:1
      pageEnd:7
      license:http://creativecommons.org/publicdomain/zero/1.0/
      sameAs:https://doi.org/10.1186/s13014-020-01673-6
      keywords:
         Rectal cancer
         Radiotherapy
         Chemotherapy
         Immunotherapy
         Neo-adjuvant therapy
         Cancer Research
         Oncology
         Imaging / Radiology
      image:
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      author:
            name:Ali Shamseddine
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                  name:American University of Beirut Medical Center
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            name:Youssef H. Zeidan
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                  name:American University of Beirut Medical Center
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                     name:Division of Hematology/Oncology, Department of Internal Medicine, Naef K. Basile Cancer Institute - NKBCI, American University of Beirut Medical Center, Beirut, Lebanon
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            address:
               name:Department of Radiation Oncology, King Hussein Cancer Center, Amman, Jordan
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      name:Ali Dabous
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            address:
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            address:
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               type:PostalAddress
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      name:Omar Jaber
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      name:Maya Charafeddine
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            address:
               name:Division of Hematology/Oncology, Department of Internal Medicine, Naef K. Basile Cancer Institute - NKBCI, American University of Beirut Medical Center, Beirut, Lebanon
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      name:Fady Geara
      affiliation:
            name:American University of Beirut Medical Center
            address:
               name:Department of Radiation Oncology, American University of Beirut Medical Center, Beirut, Lebanon
               type:PostalAddress
            type:Organization
PostalAddress:
      name:Division of Hematology/Oncology, Department of Internal Medicine, Naef K. Basile Cancer Institute - NKBCI, American University of Beirut Medical Center, Beirut, Lebanon
      name:Department of Radiation Oncology, American University of Beirut Medical Center, Beirut, Lebanon
      name:Division of Hematology/Oncology, Department of Internal Medicine, Naef K. Basile Cancer Institute - NKBCI, American University of Beirut Medical Center, Beirut, Lebanon
      name:Division of Hematology/Oncology, Department of Internal Medicine, Naef K. Basile Cancer Institute - NKBCI, American University of Beirut Medical Center, Beirut, Lebanon
      name:Division of Hematology/Oncology, Department of Internal Medicine, Naef K. Basile Cancer Institute - NKBCI, American University of Beirut Medical Center, Beirut, Lebanon
      name:Division of Hematology/Oncology, Department of Internal Medicine, King Hussein Cancer Center, Amman, Jordan
      name:Department of Hematology/Oncology, Hotel-Dieu de France University Hospital, Beirut, Lebanon
      name:Department of Pathology and Laboratory Medicine, American University of Beirut Medical Center, Beirut, Lebanon
      name:Division of Hematology/Oncology, Department of Internal Medicine, Naef K. Basile Cancer Institute - NKBCI, American University of Beirut Medical Center, Beirut, Lebanon
      name:Division of Hematology/Oncology, Department of Internal Medicine, Naef K. Basile Cancer Institute - NKBCI, American University of Beirut Medical Center, Beirut, Lebanon
      name:Division of Hematology/Oncology, Department of Internal Medicine, King Hussein Cancer Center, Amman, Jordan
      name:Division of Hematology/Oncology, Department of Internal Medicine, King Hussein Cancer Center, Amman, Jordan
      name:Division of Hematology/Oncology, Department of Internal Medicine, King Hussein Cancer Center, Amman, Jordan
      name:Division of General Surgery, Department of Surgery, American University of Beirut Medical Center, Beirut, Lebanon
      name:Division of General Surgery, Department of Surgery, American University of Beirut Medical Center, Beirut, Lebanon
      name:Department of Radiation Oncology, King Hussein Cancer Center, Amman, Jordan
      name:Department of Radiation Oncology, King Hussein Cancer Center, Amman, Jordan
      name:Department of Surgical Oncology, King Hussein Cancer Center, Amman, Jordan
      name:Department of Surgical Oncology, King Hussein Cancer Center, Amman, Jordan
      name:Department of Surgical Oncology, King Hussein Cancer Center, Amman, Jordan
      name:Division of Gastroenterology, Department of Internal Medicine, King Hussein Cancer Center, Amman, Jordan
      name:Department of Pathology, King Hussein Cancer Center, Amman, Jordan
      name:Division of Hematology/Oncology, Department of Internal Medicine, Naef K. Basile Cancer Institute - NKBCI, American University of Beirut Medical Center, Beirut, Lebanon
      name:Department of Radiation Oncology, American University of Beirut Medical Center, Beirut, Lebanon

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