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Radiotherapy clinical trials

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NCT ID: NCT05349552 Recruiting - Radiotherapy Clinical Trials

Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different Sites

Start date: May 1, 2022
Phase:
Study type: Observational

SBRT (stereotactic radiotherapy) can provide a higher dose to the target area without increasing the risk of surrounding normal tissue / organ injury in selective cases. At present, SBRT has been widely used in radiotherapy of lung cancer and it can also play a better local control for lung metastasis. However, there are parallel organs and series organs in the chest, and different organs have different tolerance to radiotherapy, so the toxicities of SBRT in different sites are different, and the prescription dose is also different. This study intends to make a detailed division of the chest region and explore the safety and efficacy of SBRT in different areas. It is divided into four types: chest wall type: the lesion is directly adjacent or overlapped with the chest wall; peripheral type: the lesion is more than 1cm away from the chest wall and more than 2cm away from the bronchial tree; central type: the lesion is less than 2cm away from the bronchial tree; ultral-central type: the lesion is directly adjacent or overlapped with the mediastinal structure. 48-60Gy / 4-10f (EQD2 = 62.5Gy ~ 99.7Gy) was given according to the location of the tumor. Main outcome measures are local progression free survival and radiation toxicities; secondary outcome measure is overall survival.

NCT ID: NCT05344235 Recruiting - Prostate Cancer Clinical Trials

Observational Study on Extreme Hypofractionation for Localized Prostate Cancer

OBELIX PCa
Start date: April 25, 2022
Phase:
Study type: Observational [Patient Registry]

Radiotherapy (RT) is an established treatment option for localized prostate cancer (PCa), with cure rates similar to those of radical prostatectomy. In the last decade, conventionally fractionated RT (1.8-2.0 Gy per fraction to 78-80 Gy) has been replaced by moderately hypofractionated RT (2.3-3.65 Gy per fraction to 56-70 Gy). The rationale behind this change is the scientific level 1 evidence that a higher dose per fraction may improve the cost-benefit of RT due to the specific radiobiology of PCa (a lower alpha/beta than that of adjacent healthy tissues). Additionally, there is a practical advantage both for patients and the radiation department due to a reduced number of fractions. More recently, extreme hypofractionation or stereotactic body radiotherapy (SBRT) (7-9.5 Gy per fraction to 36-43 Gy in 4-7 fractions) has been introduced as RT modality, and proved to be an effective and safe treatment option for patients with low and intermediate clinically-localized PCa, with similar incidence of late toxicity and 5-year disease free survival outcomes when compared to hypofractionated and conventional radiotherapy regimens. International guidelines endorse extreme hypofractionated SBRT as routine treatment option for low and intermediate risk PCa patients. For high-risk prostate cancer, preliminary results of ongoing prospective studies are promising, but these data are not yet mature enough to recommend extreme hypofractionated SBRT in high-risk prostate cancer. Upon this, ongoing prospective trials handle strict eligibility criteria hereby selecting patients with few comorbidities. This may not necessarily fully reflect the real life patient population. Indeed, patients with a large prostate size, a history of transurethral resection of the prostate (TURP), or 'significant' urinary baseline symptoms may be at risk for experiencing increased toxicity. Based on this concern, these patients were excluded from ongoing clinical trials. However, whether these patients will really develop more toxicity, is a theoretical concern, not yet based on clinical evidence. It is our hypothesis that using modern radiotherapy such as volumetric arc therapy (VMAT) and image-guided radiotherapy (IGRT) - both standard technologies at the Radiation-Oncology department in Leuven University Hospitals - extreme hypofractionated SBRT can be successfully implemented in the treatment of intermediate risk and a select group of high-risk PCa patients and/or patients with pre-existing urinary morbidity.

NCT ID: NCT05310383 Recruiting - Immunotherapy Clinical Trials

Tislelizumab and Radiotherapy for Recurrent Cervical Cancer

Start date: March 27, 2022
Phase: Phase 2
Study type: Interventional

This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel plus bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. The total treatment periods are no more than 6 cycles. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.

NCT ID: NCT05310305 Recruiting - Radiotherapy Clinical Trials

PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer

Start date: March 26, 2022
Phase:
Study type: Observational

This study is to investigate retrospectively the effects of combination of immune checkpoint inhibitors anti-programmed death-1 antibody (PD-1 antibody) and radiotherapy for recurrent, metastatic and persistent advanced cervical carcinomas. Patients may or may not accept PD-1 antibody as maintenance therapy. Patients are followed up and the survival outcomes are evaluated. The primary endpoint are objective remission rate. The secondary endpoints are progression-free survival, overall survival and severe adverse events.

NCT ID: NCT05290194 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma

Start date: March 28, 2022
Phase: Phase 2
Study type: Interventional

This is a single-arm, multicenter, prospective, open-label phase II clinical trial of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy treating oligometastatic nasopharyngeal carcinoma, the main purpose of which is to evaluate the efficacy of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma.

NCT ID: NCT05213416 Recruiting - Radiotherapy Clinical Trials

BETY-BIOPSYCHOSOCIAL QUESTIONNAIRE IN PARTİCİPANTS RECEIVING RADIOTHERAPY

Start date: February 1, 2020
Phase:
Study type: Observational

The aim of this study is to investigate the validity and reliability of BETY-BQ as a biopsychosocial assessment tool in individuals receiving radiotherapy.

NCT ID: NCT05192447 Recruiting - Radiotherapy Clinical Trials

The Cognitive-Behavioral Dysfunctions and the Potential of Neuroplasticity in Brain Tumors Patients During Radiotherapy

REHABrain
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Primary and secondary brain tumors are a constant challenge for the medicine. Tissue sensitivity to ionizing radiation differs and depends on numerous factors and the same dose of radiation may produce different effects in particular structures of the CNS. It can also affect the surrounding healthy tissues and lead to adverse effects like the cognitive or physical function impairment. One of brain structures most sensitive to ionizing radiation is the limbic system, especially the hippocampus, because it is here that the postnatal neurogenesis takes place via neural stem cells, which are a self-renewing population of precursor cells. There have been no studies that would thoroughly examine the impact of different CNS radiation therapy techniques on the cognitive function, potential neuroplasticity markers or blood-brain barrier damage in brain tumor patients with a concomitant use of neurocognitive combination therapies or physical exercise, and their impact on the CNS function. The aim of the study is to assess the impact of selected RT techniques: IMRT, WBRT, and CyberKnife (SRS) on the processes regulating cognitive and physical function in patients with primary (Group III and IV, WHO, 2016) and metastatic CNS tumors. The secondary objective is the analysis of the effect of selected forms of neurorehabilitation on the parameters studied. The study will be a prospective clinical trial conducted in 150 patients. Patient evaluation will be carried out before RT, after RT, during a follow-up visit-3 months after RT, and finally after 6 months. The methods will be used: analysis of the blood-brain barrier permeability markers including exact connection proteins, markers confirming neuroplasticity of the brain, cerebral secretory activity, and onco- and anti-neuronal antibody activity, brain structure analysis (MRI) and volume testing of selected brain structures, and assessment of cognitive and physical function of the patients. The study will be a part of the search trend aiming to explain the mechanism of the formation of cognitive-behavioral disorders in humans based on the most fundamental principles governing information processing in CNS, and the impact of neoplasia and ionizing radiation on selected brain structures and functions. The results of the study might become a starting point for the formulation of new guidelines on the level of physical activity or cognitive exercise in patients treated with CNS radiation therapy.

NCT ID: NCT05176002 Recruiting - Immunotherapy Clinical Trials

Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma.

Start date: September 23, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is an exploratory phase II clinical study designed to evaluate the safety and efficacy of Camrelizumab in combination with standard radiotherapy as preoperative neoadjuvant therapy for patients with resectable esophageal squamous cell carcinoma. In the study, all subjects who met the enrollment criteria are enrolled after giving full informed consent and signing the enrollment informed consent form, and received radical surgery within 4-8 weeks after completion of neoadjuvant Camrelizumab in combination with standard radiotherapy. The safety evaluation indicators for the study were so adverse events and the number and proportion of subjects who discontinued treatment due to adverse events. The main efficacy indicators of the study were the rate of major pathological remission and the rate of complete pathological remission. A total of 26 cases had to be enrolled in the study. Phase I enrollment was 12 cases, with at least 5 cases achieving efficacy to proceed to Phase II. The trial was considered successful when 14 cases were enrolled in the second phase and the total number of effective cases was greater than 13. The need for postoperative adjuvant treatment and the adjuvant treatment plan were determined by the investigator, and all subjects were required to complete the study's follow-up plan after surgery.

NCT ID: NCT05167669 Recruiting - Pain Clinical Trials

Pain Relief in Symptomatic Bone Metastases With Adjuvant Hyperthermia MR Guided HIFU

BM-RT-HIFU
Start date: October 1, 2022
Phase: Early Phase 1
Study type: Interventional

Metastatic disease to the bone is a common cause of pain. External beam radiation therapy (EBRT) is the standard palliative treatment BUT pain improvement is observed in 60% to 80%. Combination of hyperthermia (HT) with radiation is strongly compelling. MR is providing accurate, tissue-independent thermometry for intra-procedural guidance of thermal therapy. In this project we aim to combine in an adjuvant setting mild hyperthermia to EBRT for sustained relief of pain in patients with symptomatic bone metastases.

NCT ID: NCT05129215 Completed - Rectal Cancer Clinical Trials

Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)

PORTLARS
Start date: March 6, 2020
Phase:
Study type: Observational

Bowel dysfunction is common after a restorative rectal cancer resection. Neoadjuvant radiotherapy is an influential factor that impairs bowel function and quality of life. However, almost half patients who have received primary surgery with preoperative radiotherapy are able to restore a good or moderate bowel function in the long term. This multicenter observational study aims to identify the risk factors of severe bowel dysfunction after rectal cancer resection and neoadjuvant radiotherapy, in accordance with the LARS score, and to build a model that predicts long-term major LARS in the early stage of follow-up. Development and validation cohorts are enrolled from tertiary hospitals in China.