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Radiotherapy Side Effect clinical trials

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NCT ID: NCT04685460 Recruiting - Breast Neoplasms Clinical Trials

3D Printed Bolus in Post-mastectomy Radiotherapy

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Recently, there is growing interest in the application of three-dimensional (3D) printed bolus to radiotherapy.At present, the researches on the application of 3D-printed bolus in breast cancer are mainly focused on air gap between skin and bolus or electron beam conformal therapy [7,15], there are no clinical experience with customized 3D-printed bolus for volumetric modulated arc therapy (VMAT) in daily practice has been published up to now. We aim to evaluate dosimetry and application of 3D-printed bolus for the post-mastectomy radiotherapy (PMRT) with Volumetric modulated arc therapy (VMAT). Seventy five patients with breast cancer receiving radiotherapy following post-mastectomy in our department were randomly selected in this study. The accuracy of fit of the 3D-Printed bolus to the chest wall was improved significantly relative to conventional bolus.This study demonstrates customized 3D-printed bolus in post-mastectomy radiation therapy improves fit of the bolus compared to conventional bolus. Furthermore, VMAT based on 3D-printed bolus significantly improves the chest wall target coverage and the conformity of plan, and reduces the dose of ipsilateral lung and heart, compared to conventional bolus.

NCT ID: NCT04670991 Recruiting - Cancer Clinical Trials

Evaluation of ExacTrac® Imaging Device for Repositioning Quality of Patients Undergoing an External ENT Radiotherapy

ST-IGRT-ORL
Start date: January 13, 2021
Phase: N/A
Study type: Interventional

Monocentric, category 2 study according to Jardé Law (minimal risks and constraints) of three prospective cohorts: Tumors located at the oropharynx, the oral cavity and the larynx-hypopharynx. The main objective is to evaluate the 3D vector of the absolute residual positioning error observed with the CBCT reference imaging, after repositioning performed with ExacTrac®. The secondary objectives are to evaluate: 1) the rate of residual errors ≥2mm (translations in all directions) and ≥2 ° (rotations in all directions) on CBCT imaging after repositionning with the ExacTrac® system; 2) the Evaluation of intrafraction movements amplitude by analyzing the ExacTrac® images taken during the irradiation; 3) the evolution of the relative position of the volume of the tumor at high risk of recurrence (CTVTHR) in relation to the spine over the entire duration of the treatment; 4) the impact of patient's weight loss, the advancement of RT and the realization of a chemotherapy / targeted therapy concomitant with RT, on the evolution of the relative position of the CTVTHR in relation to the column vertebral; 5) the dosimetric consequence of a strict bone registration on the CTVTHR coverage by calculating the post-treatment dose on the CBCT imaging.

NCT ID: NCT04612907 Recruiting - Prostate Cancer Clinical Trials

Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer

Hypo-M1
Start date: October 31, 2022
Phase: N/A
Study type: Interventional

de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested.

NCT ID: NCT04580784 Recruiting - Breast Cancer Clinical Trials

Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer

Start date: December 10, 2018
Phase: Phase 2
Study type: Interventional

The current study is a prospective phase II study; Eligible patients will receive hypofractionated Irradiation at a total dose of 28.5Gy in 5 once-weekly fractions of 5.7Gy in 5 weeks to the Whole Breast or chest wall with or without peripheral lymphatic irradiation.

NCT ID: NCT04550910 Recruiting - Clinical trials for Radiotherapy Side Effect

RCT Comparing 2 Radiotherapy HypoFractionation Schedules In Breast Cancer Patients

Breastcancer
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

This is a prospective randomized Phase III trial to assess efficiency of two post mastectomy hypofractionation schedules (40 Gy /15 fx / 3 weeks, 5 days per week VS 28.5 Gy delivered in 5 once-weekly fractions of 5.7 Gy each week) as adjuvant radiotherapy in female patients with breast cancer after mastectomy.

NCT ID: NCT04472845 Recruiting - Breast Cancer Clinical Trials

HYPofractionated Adjuvant RadioTherapy in 1 Versus 2 Weeks in High-risk Patients With Breast Cancer (HYPART).

HYPART
Start date: March 30, 2021
Phase: N/A
Study type: Interventional

We at PGIMER have been practicing hypofractionated radiotherapy in breast cancer patients for the last 4 decades. Our standard doses have been 35Gy/15#/3wks to the chest wall after mastectomy and 40Gy/16#/3wks after breast conserving surgery (BCS).It is also a routine practice in the UK and in a few centers in Canada. Hypofractionation reduces treatment time to half while maintaining cosmesis and gives control rates equal to conventional fractionation. As breast cancer is a leading cancer in females and radiation therapy is an important part of its local management, hypofractionation helps radiation centers worldwide to meet the growing need for radiation treatment in breast cancer, particularly in developing countries where resources are limited. It also reduces the financial burden on the patient and family. In this study we want to evaluate the impact of reducing the treatment duration from 3 weeks to 1 week. Eligible patients with breast cancer after mastectomy or BCS will be treated with a radiotherapy dose of 26Gy in 5 fractions over 1 week in the study arm and 40Gy in 15 fractions over 2 weeks in the control arm. The primary endpoint of this noninferiority study will be locoregional tumour control. Secondary endpoints will be early and late radiation toxicities, quality of life, contralateral primary tumours, regional and distant metastases, survival and second cancers. A total of 1018 patients will be randomised (1:1) to receive 1 week or 2 weeks of radiotherapy. An event-driven analysis will be performed after at least 94 patients have documented locoregional recurrences.

NCT ID: NCT04395339 Recruiting - Breast Cancer Clinical Trials

GM1 Prophylaxis for WBRT Related Cognitive Dysfunction

GLORY
Start date: May 15, 2020
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of GM1 for preventing cognitive impairment related to whole brain radiotherapy in breast cancer patients with brain metastases. And explore the clinical and molecular parameter for predicting severe cognitive impairment induced by WBRT and gaining benefit from GM1. Primary Endpoint: the change of Hopkins Verbal and Learning Test-Revised Delayed Recall,HVLT-R DR,before and after WBRT Secondary ENDPOINT: the change of Alzheimer's Disease Assessment Scale-Cognitive,ADAS-Cog before and after WBRT;severe cognitive impairment percentage and onset time; Design:204 patients will be randomly assigned to exp.group,102 cases,and 102 cases of control group.

NCT ID: NCT04115267 Recruiting - Cancer Clinical Trials

Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies

AtTRIBut
Start date: September 13, 2019
Phase:
Study type: Observational [Patient Registry]

Every year, new molecular agents enter the market with more and more patients receiving these treatments, especially in the metastatic setting. These molecular agents could correspond to immunotherapy and modulators of signaling pathways. More than 50% of cancer patients will receive radiation therapy during the course of their illness, including radiotherapy aimed a palliating symptoms secondary to metastatic diseases. Therefore, there will be an increasing number of patients who will be receiving radiotherapy while they are still receiving molecular agents. A better understanding of the interaction of these two treatment modalities is needed.

NCT ID: NCT04022018 Recruiting - Cervical Cancer Clinical Trials

Study on Adaptive Radiotherapy and Multimodal Information of Cervical Cancer Assisted by Artificial Intelligence

SOARAMIOCC
Start date: December 18, 2019
Phase: N/A
Study type: Interventional

The standard treatment for non-operative cervical cancer is concurrent external radiation therapy and chemotherapy followed by brachytherapy. During the period of radiotherapy, organ movement and tumor shrinkage may lead to insufficient or excessive radiation dose for the tumor and organs at risk. Adaptive radiotherapy can use images information acquired during treatment as feedback to reduce errors. Total 122 cases of cervical cancer with stage IB2-IVA will be randomly enrolled. Concurrent external volumetric rotational intensity modulated radiotherapy and chemotherapy followed by image-guided adaptive brachytherapy is the treatment strategies of control group patients. Concurrent adaptive external volumetric rotational intensity modulated radiotherapy and chemotherapy followed by image-guided adaptive brachytherapy is the treatment strategies of experimental group patients. CT repositioning will be performed after 15fractions of external radiotherapy, then new target volume will be contoured and new radiotherapy plan will be formulated with the assistance of artificial intelligence program. New radiotherapy plan will be performed from the 17th fraction external radiotherapy. Information on side effects, survival, dosimetry, imaging, clinical features, and cost-effectiveness will be collected. The statistical analysis is as follows, First is the difference in grade 3 side effects between the two groups. Second is 2-year PFS and OS differences between the two groups. Third is relationship between dosimetric differences and prognosis. Fourth one is to analyze the prognostic and predictive factors of adaptive radiotherapy from the patient's clinical characteristics, Positron emission tomography-computed tomography(PET/CT), Magnetic Resonance Imaging(MRI) and other multimodal information. Fifth is cost-benefit analysis of Artificial Intelligence(AI).

NCT ID: NCT03918382 Recruiting - Clinical trials for Head and Neck Cancer

Patient-Reported Outcomes in Head and Neck Cancer

DAHANCA PRO
Start date: June 13, 2019
Phase: N/A
Study type: Interventional

Weekly electronic reporting of patient-reported outcomes will be tested in a national trial in participants undergoing radiotherapy for head and neck cancer. The study is a national study under the Danish Head and Neck Cancer Group (DAHANCA) and all 6 centers in Denmark will participate. The clinical endpoints will be: - Quality of life - Objective toxicity score (DAHANCA) - Opioid treatment - Tube feeding - Weight loss - Hospitalization - Compliance to treatment