View clinical trials related to Pelvic Tumor.
Filter by:This prospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios. Primary endpoint: - 10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART Secondary endpoints: - Clinical endpoints: Tumor control, late toxicities compared to conventional irradiated patients, quality of life and patient-reported outcomes - Technical endpoints: Target volume, target coverage, dose to organs at risk, anatomical variability score
A single-arm clinical trial was designed in this study. The surgeon will perform urological telesurgery for patients using Chinese domestically produced "MicroHand S" surgical robot system. The "MicroHand S" surgical robot system consists of two physically separated subsystems named the "surgeon console" and the "patient side cart". The surgeon console includes a stereo image viewer, two master manipulators, a control panel and several foot pedals. The patient side cart includes a passive arm that can slide in the up-down direction and be adjusted forward and backward, a swivel head that can rotate around the vertical axis, and three slave arms. In addition, surgical instruments and sterile bags are the essential accessories for the "patient side cart". The principle of the telesurgery is as follows: the surgeon console takes the surgeon's input and translates manipulation into a control signal. After network transmission, the signals will be received by the patient side cart and will be used to control the slave robot to manipulate the instruments to perform the operation within the patient's cavity. The 3D images captured by the endoscopic camera will be simultaneously sent back to the screen of the surgeon console as visual feedback. Data between the surgeon console and the patient side cart will be transmitted through a 5G network or other advanced network networking scheme. The surgeon remotely manipulates the slave arms and performs surgeries for patients in remote areas. The safety and efficacy of the robot system in remote clinical treatment will be verified by the primary and the secondary evaluation criteria. One hundred patients with urological diseases will be enrolled in the clinical trial. Primary evaluation criterion: The success rate of the surgery. Surgery success is defined as that all surgeries are performed remotely and safely without transfering to other types of surgery, such as open surgery or normal robot-assisted surgery. Secondary evaluation criteria: Operative time, blood loss, postoperative pain, preoperative adjusting time, hospitalization time, average network latency, task load, peer recognition, anxiety index. Patient enrollment: This experiment aims to investigate the safety and effectiveness of the domestic robot system in clinical urological surgery under the current network networking scheme. It is planned that 100 patients with urinary system diseases will participate in the clinical trial.
The main purpose of this study is to assess the efficacy of precision preoperative embolization in decreasing operative blood loss, reducing surgical complications in pelvic tumor surgery. Furthermore the study aims at describing the vascularity in a series of pelvic tumors, and to correlate this with perioperative blood loss.
Background: Acetabular reconstruction in situ after extensive pelvic resection is technically challenging because the significant loss of bone stock and bony landmarks. The aim of the present study was to investigate the feasibility of an individualized navigation template for acetabular reconstruction following pelvic malignancy resection. Methods: This retrospective cohort study included patients who underwent type II or II+III pelvic tumor resection and reconstruction using a modular hemipelvic prosthesis. In the template-guided group (n = 10), a navigation template was designed and applied to assist acetabular reconstruction. In the traditional operation group (n = 14), the patients underwent the same surgery but without the navigation template. To compare the displacement of the hip rotation center before and after surgery between the two groups, an innovative method based on pelvic CT was developed and a validation group of cases was used to assess the effectiveness of this measurement approach. In the validation group (n = 12), patients undergoing periacetabular puncture or curettage without hip joint reconstruction were included. The displacements for the validation group were calculated and compared with 0 cm, the theoretical value. Subsequently, the displacements between the template-guided group and the traditional operation group were compared.
Radiotherapy (combined with chemotherapy) is commonly used in the curative treatment of pelvic tumours, such as in cervical, vulvar and anal cancer. In these patients, cure rates are high but may be associated with significant treatment-related toxicities, especially dermatologic, gastrointestinal, genitourinary and hematologic toxicity. Accurate treatment planning and dose delivery is essential for radiotherapy in order to be effective in terms of local tumour control and to reduce radiation-induced side effects. However, accuracy is challenged by tumour and organ motion from fraction to fraction (interfraction movements). At present, radiotherapy treatment planning is typically performed on one planning-CT scan which is performed before the start of the treatment. However, interfraction set up variations and organ motions can lead to differences between the calculated dose distribution on the planning-CT and the radiation dose actually received by the tumour and normal organs (actual given dose). Current photon radiotherapy of the pelvic area is relatively insensitive to these changes and margins from CTV to PTV ensures an adequate dose coverage of the tumour area. Despite newer techniques in photon therapy, like intensity modulated radiotherapy (IMRT), critical organs still receive a substantial amount of dose leading to clinically relevant acute and late side effects. With proton beam therapy, the amount of radiation dose to the organs at risk can be significantly reduced. For proton beam therapy (PBT) however, knowledge of tumour and organ motion will be more important. The major potential advantages of PBT for tumours in the pelvic area in terms of prevention of radiation-induced side effects are challenged by differences in bladder volume, rectal filling and air gaps especially in the small bowel, sigmoid and rectum. Setup errors and organ motion cause geometric displacement of the tumours and normal tissues, which deteriorates the dose gradients from target volume to normal tissue. Furthermore, it can result in changes in tissue densities in the beam path, which can alter the position of the Bragg peaks, in turn leading to distorted dose distributions, usually manifesting as significant local under and/or over dosage. In this study, the investigators want to evaluate the impact of inter and intrafractional tumour and organ motion on photon and proton radiotherapy treatment planning in order to create robust intensity modulated photon- and/or proton treatment plans (IMRT, IMPT) with the final aim to lower treatment related toxicity. Objective: To explore the extent of inter- and intrafraction anatomical changes of the tumour and surrounding normal tissues, throughout the full course of treatment, and to subsequently assess the impact of these changes on the nominal planned dose. This information is required to design robust treatment plans (photon and/or proton) that will ensure optimal local tumour control while reducing toxicity. Study design: Pilot-study (40 patients). Study population: Patients with cervical, vulvar or anal cancer, who are planned for radiotherapy (with or without chemotherapy) with curative intent. Intervention (if applicable): Not applicable. Main study parameters/endpoints: Robustness parameters (homogeneity index; coverage of clinical target volume), dose to organs at risk (OARs), such as the small bowel, rectum, bladder and bone marrow. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During the radiotherapy treatment course, patients will undergo weekly repeat planning CT scans without contrast agents in order to evaluate the impact of intra and inter-fraction tumour and organ motion. The additional radiation dose of these 5 extra CT's is relatively low (5 x 8 mSv, plus 1 x 22 mSv for the 4D CT scan) in relation to the therapeutic radiation dose (50.4-85 Gy). The risks are therefore negligible and the burden is low.
SGO Society of Gynecologic Oncologists Data Outcomes Project.