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  • A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

    This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab as a 1L treatment for patients with mNSCLC whose tumors express PD-L1.

    Phase

    3

    Span

    295 weeks

    Sponsor

    AstraZeneca

    Fortaleza

    Recruiting

  • Quadriceps Strengthening At Different Angles in Patellofemoral Pain

    Participants with patellofemoral pain will be randomized into two intervention groups. All participants will start with a warm-up on a stationary bike, followed by dynamic stretching exercises targeting the quadriceps, hamstrings, calf muscles, adductors, and abductors. Open kinetic chain exercises will be performed using a leg extension machine, while closed kinetic chain exercises will include free squats and Bulgarian squats. The Limited-RoM Quadriceps Strengthening group will perform open-kinetic-chain quadriceps strengthening exercises within a range of 90° to 45° of knee flexion and closed-kinetic-chain within a range of 0° to 45°. The Patient-Guided-RoM Quadriceps Strengthening group will perform quadriceps strengthening exercises in both open and closed kinetic chains to the maximum tolerated by the patient based on their symptoms. The patient-guided maximum range of motion will be adjusted based on pain intensity, comfort, and patient response, following a shared decision-making approach with a clinician. The goal will be to maintain exercises at the greatest possible range of motion. The identification of the patient-guided angle in both open and closed kinetic chain exercises will be determined as follows: the patient will perform 10 maximum repetitions on the leg with PFP, prioritizing range of motion over load. During the execution, the range of motion and load will be guided by the numerical pain rating scale and the perceived exertion scale. Participants will complete 12 sessions, twice a week, supervised by a physiotherapist. Assessments will be conducted at baseline, six weeks, and six months, evaluating pain, function, kinesiophobia, crepitus, perception of effect, and weekly pain-killer consumption.

    Phase

    N/A

    Span

    88 weeks

    Sponsor

    Universidade Federal do Ceara

    Fortaleza, Ceará

    Recruiting

  • Adrenal Project: Clinical and Epidemiological Characterization of Adrenocortical Carcinoma in a Brazilian Cohort

    Adrenocortical carcinoma is one of the rarest neoplasms in the world. In Brazil, especially in the South and Southeast regions, the incidence of adrenocortical tumors is around 15 times higher than in the rest of the world, largely attributed to the significant prevalence of the TP53-R337H germline mutation in this population. In view of this characteristic, the clinical and epidemiological characterization of this cohort, as well as the identification of prognostic factors, is of great importance. The starting point for this project was the cohort of 66 participants with adrenal carcinoma included in the final project of the medical residency in clinical oncology at the A.C. Camargo Cancer Center by student Rafael Haikal dos Santos Abduch. The aim is to include case studies from the main Brazilian site that have followed up and treated patients with adrenal carcinoma.

    Phase

    N/A

    Span

    46 weeks

    Sponsor

    Latin American Cooperative Oncology Group

    Fortaleza, Ceará

    Recruiting

  • A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

    Phase

    3

    Span

    336 weeks

    Sponsor

    AstraZeneca

    Fortaleza

    Recruiting

  • MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

    Adult patients with histologically proven diagnosis of pleural mesothelioma with advanced unresectable disease are eligible to be enrolled. Patients will be randomized 1:1 to receive Volrustomig (MEDI5752) + Carboplatin + Pemetrexed or the investigator's choice of platinum+Pemetrexed or Nivolumab+Ipilimumab, based on their histology.

    Phase

    3

    Span

    227 weeks

    Sponsor

    AstraZeneca

    Fortaleza

    Recruiting

  • Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension

    This phase III, multicenter, randomized, double-blind, controlled, parallel trial will evaluate the non-inferiority of the association between candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg in relation to Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12 5mg + amlodipine 5mg) in the treatment of systemic arterial hypertension. A total of 698 participants will be included. Follow-up visits will occur four, eight, and twelve weeks after the date of the randomization visit. A telephone contact will be performed 30 days after the end of treatment. The primary efficacy outcome is the mean change in blood pressure, measured at the research site, 12 weeks after starting treatment, compared to baseline. Incidence of adverse events will be collected from the first dose of treatment up to 30 days after the end of the treatment foreseen in the protocol.

    Phase

    3

    Span

    45 weeks

    Sponsor

    Hospital Israelita Albert Einstein

    Fortaleza, Ceará

    Recruiting

  • Radiotherapy With Extreme Hypofractionation in Patients With Breast Cancer in Brazil: a Retrospective Cohort Study

    All patients diagnosed with breast cancer who meet the eligibility criteria at participating centers will be included. Data will be collected from medical records at selected centers. Data collection will start from the location activation date. Data from up to 500 patients are expected to be collected at centers across Brazil. Patients recruited for this study will be identified at participating centers. Data on clinical, demographic and socioeconomic variables will be collected, as well as data on treatments performed and outcomes. The patient data sources will be the patients' medical records. Patients will continue to receive treatment and clinical evaluations for their illness as determined by their medical team, in accordance with the standards of care and usual clinical practice at each center. No intervention is proposed in this study.

    Phase

    N/A

    Span

    82 weeks

    Sponsor

    Latin American Cooperative Oncology Group

    Fortaleza, Ceará

    Recruiting

  • Organosilane for Surface Cleaning in Intensive Care Units

    Phase

    2/3

    Span

    60 weeks

    Sponsor

    Hospital Israelita Albert Einstein

    Fortaleza

    Recruiting

  • REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)

    This study will evaluate the efficacy and safety of zipalertinib in combination with standard chemotherapy with pemetrexed and a platinum agent (either carboplatin or cisplatin) in patients with previously untreated, locally advanced or metastatic nonsquamous NSCLC harboring EGFR ex20ins mutations. The study will be conducted in two parts: - Part A: Safety lead-in to determine the recommended dose of zipalertinib in combination with standard chemotherapy pemetrexed and a platinum agent (either carboplatin or cisplatin) to be studied in Part B of the study. - Part B: Randomized, controlled, open-label, multinational Phase 3 study to assess the efficacy and safety of zipalertinib in combination with standard chemotherapy with pemetrexed and a platinum agent (either carboplatin or cisplatin) compared to standard chemotherapy alone. Patients randomized to the chemotherapy-only treatment arm in Part B may receive treatment with zipalertinib as monotherapy after BICR-assessed progressive disease (PD) is documented (optional "crossover arm"). An independent data monitoring committee (IDMC) will be established to monitor interim safety Data. A treatment cycle is defined as 21 days for both parts of the study. Part A: Safety Lead-In The primary objective of Part A is to determine the recommended dose of zipalertinib administered in combination with pemetrexed and a platinum agent (either carboplatin or cisplatin) to be studied in the Phase 3 portion of this study. Approximately 6-12 patients will receive zipalertinib administered at an initial dose of zipalertinib PO BID (Dose Level 1) in combination with pemetrexed and carboplatin or cisplatin on a 21-day cycle. Patients may continue to receive study treatment until documentation of progressive disease (PD) or until other withdrawal criteria are met, whichever comes first. Patients will be enrolled using a rolling-6 design,35 and the determination of the dose of zipalertinib to be used in Part B of the study will be informed by the incidence of dose-limiting toxicities (DLTs) observed during Cycle 1. Part B: Phase 3 Enrollment into the Phase 3 portion of the study will begin following completion of Part A. Approximately 260 patients will be randomized on a 1:1 basis to receive pemetrexed and a platinum agent (either carboplatin or cisplatin) with or without zipalertinib on a 21-day cycle. Carboplatin or cisplatin will be administered for 4 cycles. Patients may continue to receive zipalertinib (experimental study arm) and pemetrexed (both study arms) until documentation of PD or until other withdrawal criteria are met, whichever comes first.

    Phase

    3

    Span

    165 weeks

    Sponsor

    Taiho Oncology, Inc.

    Fortaleza, Ceará

    Recruiting

  • A Study of Sigvotatug Vedotin Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer

    Phase

    3

    Span

    212 weeks

    Sponsor

    Seagen, a wholly owned subsidiary of Pfizer

    Fortaleza

    Recruiting

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