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Adjuvant Radiotherapy clinical trials

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NCT ID: NCT06272214 Not yet recruiting - Clinical trials for Adjuvant Radiotherapy

Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma in the Era of Immunotherapy

Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

This study is a multicenter, prospective, randomized phase II trial aimed at exploring the value of adjuvant radiotherapy in patients at high risk of recurrence after neoadjuvant chemoradiotherapy for esophageal cancer. The study primarily includes patients with esophageal cancer who underwent neoadjuvant chemoradiotherapy and surgery and did not achieve complete pathological response (non-pCR) postoperatively and were defined as preoperative clinical stage at T3-4N+M0. Eligible patients will be randomized in a 1:1 ratio into two groups: the observation group and the adjuvant radiotherapy group. The control group consists of patients who receive surgery after neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer, followed by maintenance therapy with PD1/PDL1 inhibitors for up to 1 year or until tumor progression. The adjuvant radiotherapy group receives additional adjuvant radiotherapy on top of the control group's treatment. The specific treatment process involves receiving 2 cycles of neoadjuvant chemotherapy combined with immunotherapy (PD1/PDL1 inhibitors) before potentially curative esophageal cancer surgery. The chemotherapy regimen includes paclitaxel in combination with platinum agents, with a preference for albumin-bound paclitaxel (280mg/m2 on Day 1, or 100mg on Days 1, 8, and 15) in combination with carboplatin (AUC=5). Following surgery, patients start adjuvant radiotherapy 4-6 weeks after the operation, with a radiation dose of 45Gy/25F/5W, completed no later than 8 weeks post-surgery. Two weeks after completing radiotherapy, patients continue with immunotherapy maintenance therapy for up to 1 year or until tumor progression. Subsequently, follow-up visits are scheduled every 3-4 months for the first 3 years, every 6 months for the next 2 years, and annually thereafter. The primary endpoint is 2-year disease-free survival (DFS), and secondary endpoints include overall survival (OS), local recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), recurrence patterns, and safety assessment. Additionally, the study will explore biomarkers predicting treatment efficacy and adverse reactions in subjects, including PD-L1 expression, ctDNA clearance status, infiltrating immune cell types and quantities, cytokine expression, and other tumor biomarkers. This exploration aims to guide stratified precision treatment for patients.

NCT ID: NCT05524389 Not yet recruiting - Endometrial Cancer Clinical Trials

Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions

Start date: December 1, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and toxicity of early stage endometrial cancer based on molecular classification and conventional risk stratification adjuvant therapy decision-making, and to provide high-quality evidence-based medical evidence for individualized adjuvant therapy selection under the guidance of fine stratification system of endometrial cancer.

NCT ID: NCT04913532 Recruiting - Breast Cancer Clinical Trials

Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Start date: June 22, 2021
Phase: N/A
Study type: Interventional

Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been investigating in breast cancer. Investigators initiated this phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer.

NCT ID: NCT03997188 Completed - Dysphagia Clinical Trials

Zinc-L-Carnosine Prevents Dysphagia in Breast Cancer Patients Undergoing Adjuvant Radiotherapy

Start date: December 21, 2015
Phase: Phase 3
Study type: Interventional

Irradiation of level III and IV draining nodes in breast cancer patients is often associated with dysphagia, requiring treatment with FANS and/or steroids. The present randomized phase III trial determined whether Zinc-L-Carnosine ( Hepilor), prevents or delays the onset of dysphagia in these patients.

NCT ID: NCT03801850 Completed - Clinical trials for Breast Cancer Female

Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: MorphoBreast3D

MB3D
Start date: February 22, 2018
Phase: N/A
Study type: Interventional

Quantitative evaluation of the breast's morphological variations during radiotherapy consisting in performing three-dimensional surface acquisitions of the breast in order to study its shape and volume. Evaluation of the dosimetric impact of these variations.

NCT ID: NCT03333993 Completed - Breast Cancer Clinical Trials

Mat Pilates in Women With Breast Cancer During Adjuvant Radiotherapy

Start date: March 15, 2017
Phase: N/A
Study type: Interventional

Breast cancer is the most frequent tumor site among women in the world (FERLAY et al., 2015). In Brazil, estimates for the year 2017 indicate the occurrence of about 57,960 new cases (56.2 cases per 100,000 women); (Brazil - Ministry of Health, 2015). The increase in adjuvant therapies resulted in an estimated increase of 22 million cancer survivors worldwide (GOLDSTEIN et al., 2012). However, as survival rates increased, more women faced complications related to diagnosis and treatment (ABRAHMS et al., 2016). Adjuvant radiotherapy is a frequent treatment in breast cancer and fatigue it is the main adverse effects (HICKOK et al., 2005). Measures of intervention through physical activity have shown benefits in the increase of the functional capacity that generates a reduction of effort and decrease of the fatigue (MARKES et al., 2009). General Objective: To evaluate the influence of Mat Pilates on fatigue, quality of life, functional capacity, flexibility, lymphedema, radiodermatitis and depression, in the women with breast cancer and with an indication of adjuvant radiotherapy, at the Cancer Hospital III of the National Cancer Institute (INCA). After recruitment, women will be allocated randomly in: Intervention Group (Mat Pilates and usual activities) and Control Group (usual activities). Patients in the intervention group will be submitted to 10 sessions of Mat Pilates for a period of 5 weeks (from beginning to end of adjuvant radiotherapy). Patients assigned to the control group will not participate in the Mat Pilates program, but will maintain the usual exercises for upper limbs, guided by physiotherapists in the postoperative period. In both groups, patients will be submitted, functional capacity assessment, flexibility assessment, assessment of the presence of lymphedema, and questionnaire application of fatigue, quality of life, level of physical activity and depression. Will be performed a descriptive analysis of the population. Univariate logistic regression will be performed between the outcomes according to the exercise groups and also, for the possible confounding variables. The variables with p<0.20 will be selected for adjustment in the construction of the multiple logistic regression model. Those with p<0.05 and/or with clinical significance will be maintained in the model.

NCT ID: NCT02976402 Recruiting - SBRT Clinical Trials

Stereotactic Hypofractionated Accelerated Radiotherapy Post-Prostatectomy

SHARP
Start date: November 2016
Phase: Phase 1
Study type: Interventional

The present phase I trial evaluates the feasibility of a postoperative stereotactic hypofractionated external beam radiation therapy delivered in patients who underwent radical prostatectomy with adverse pathological features or early biochemical failure. Modern computer-driven technology enables the implementation of ultra-high hypofractionated Image-Guided Radiotherapy (IGRT) safely. Eligible patients for this study are those with: - Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy) - Pathologic (p)T3 disease, positive margin(s), Gleason score 8-10, or seminal vesicle involvement - Undetectable post-radical prostatectomy PSA that becomes detectable and then increases on 2 subsequent measurements (PSA of > 0.1 - ≤ 2.0 ng/mL) - Life expectancy: 10 years - ECOG performance status of 0 -1 - No distant metastases, based on the following workup within 60 days prior to registration - Magnetic resonance imaging (MRI) of the pelvis - PSMA/Choline Positron Emission Tomography (PET) to exclude systemic disease in patients with biochemical recurrence - Patients can be on androgen deprivation therapy - Ability to understand and willingness to sign a study-specific informed consent prior to study. Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility.