Is your age between 18 yrs and 70 yrs? |
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Are you female? |
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Do you have Locally Advanced Cervical Cancer? |
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Do you have any of these conditions: Do you have Locally Advanced Cervical Cancer?? |
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Is your age greater than or equal to 18 yrs? |
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Do you have any of these conditions: Do you have Locally Advanced Cervical Cancer?? |
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Is your age greater than or equal to 18 yrs? |
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Do you have any of these conditions: Do you have Locally Advanced Cervical Cancer?? |
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Stage IB1 and IIA cervical cancer with no regional lymph node metastases (N0) |
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Stage IVB cervical cancer with presence of distant metastases other than para-aortic lymph node metastases |
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Prior surgery for cervical cancer unless cone resection and paraaortic lymphadenectomy |
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Prior pelvic radiotherapy, other radiotherapy, chemotherapy or immunotherapy |
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Any malignancy other than the disease under study in the past 5 years excepting skin cancers such as BCC or SCC |
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Pregnant or lactating women, or intending to become pregnant during the study |
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For patient 70 years old with a G-8 score 14, unconfirmation of patient eligibility done by the onco-geriatrian at screening |
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History of clinically relevant cardiovascular disease, congestive heart failure (New York Heart Association [NYHA] Class II or greater), or a known left ventricular ejection fraction (LVEF) <50%, symptomatic coronary artery disease, poorly controlled cardiac arrhythmia, or myocardial infarction |
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Active inflammatory bowel disease, lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome |
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Serious infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia |
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Treatment with another investigational therapy within 30 days prior to initiation of the study drug |
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Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the study other than for diagnosis. The following are not considered a major surgical procedure and are therefore permitted |
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(i) placement of central venous access catheter(s) (e.g., port or similar) |
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(ii) surgical lymph node staging with no perioperative complications; (iii) |
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placement of ureteral catheters |
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\. History of severe allergic anaphylactic reactions to chimeric, human or |
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humanized antibodies, or fusion proteins |
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\. Known hypersensitivity to Chinese hamster ovary (CHO) cell products or |
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any component of the atezolizumab formulation |
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\. Any contraindication to the use of Cisplatin and/or carboplatin |
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\. History of autoimmune disease, including but not limited to myasthenia |
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gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus |
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rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis |
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associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjgren's |
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syndrome, Guillain-Barr syndrome, multiple sclerosis, meningoencephalitis, or |
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glomerulonephritis (see Appendix 6 for a more comprehensive list of autoimmune |
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diseases) with the following exceptions: patients with a history of |
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autoimmune-related hypothyroidism on a stable dose of thyroid replacement |
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hormone, patients with controlled Type 1 diabetes mellitus on a stable insulin |
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regimen, and patients with mild autoimmune skin disorders (such as eczema or |
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atopic dermatitis involving <10% of the skin) may be eligible for this study |
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\. History of idiopathic pulmonary fibrosis (IPF, including pneumonitis) |
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drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis |
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obliterans, cryptogenic organizing pneumonia), or active pneumonitis |
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\. Pre-existing hearing impairment |
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\. Peripheral neuropathy grade 2 |
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\. Positive test for human immunodeficiency virus (HIV) |
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\. Active hepatitis B (positive hepatitis B surface antigen [HBsAg] test at |
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screening) or hepatitis C (positive hepatitis C virus antibody [HCVAb] test at |
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screening). Note: Patients with past hepatitis B virus (HBV) infection or |
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resolved HBV infection (defined as having a negative HBsAg test and a positive |
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hepatitis B core antibody [HBcAb] test) are eligible |
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\. Known active tuberculosis |
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\. Receipt of a live, attenuated vaccine within 4 weeks prior to |
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randomisation or anticipation that such a live, attenuated vaccine will be |
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required during the study. Note: Patients must agree not to receive live |
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attenuated influenza vaccine (e.g., FluMist) within 28 days prior to |
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randomisation, during treatment or within 5 months following the last dose of |
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atezolizumab |
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\. Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic |
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antibody or immune checkpoint targeting agents |
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