Shinjuku ,tokyo, Japan
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
3Span
295 weeksSponsor
AstraZenecaFortaleza
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/ASpan
88 weeksSponsor
Universidade Federal do CearaFortaleza, 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/ASpan
46 weeksSponsor
Latin American Cooperative Oncology GroupFortaleza, Ceará
Recruiting
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
3Span
227 weeksSponsor
AstraZenecaFortaleza
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
3Span
45 weeksSponsor
Hospital Israelita Albert EinsteinFortaleza, 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/ASpan
82 weeksSponsor
Latin American Cooperative Oncology GroupFortaleza, Ceará
Recruiting
Organosilane for Surface Cleaning in Intensive Care Units
Phase
2/3Span
60 weeksSponsor
Hospital Israelita Albert EinsteinFortaleza
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
3Span
165 weeksSponsor
Taiho Oncology, Inc.Fortaleza, Ceará
Recruiting
A Study of Sigvotatug Vedotin Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer
Phase
3Span
212 weeksSponsor
Seagen, a wholly owned subsidiary of PfizerFortaleza
Recruiting