FASCINATEFeasibility of CBCT-Guided Adaptive Radiotherapy on Standard Linac
online CBCT-guided adaptive radiation therapy using a new software
Urogenital Diseases+25
+ Genital Diseases
+ Urinary Bladder Diseases
Treatment Study
Summary
Study start date: August 29, 2023
Actual date on which the first participant was enrolled.This study aims to explore a new way to improve the accuracy of radiation therapy for cancer patients. Normally, radiation therapy sessions can vary slightly due to changes in the patient's position or anatomy. By using a technique called online adaptive radiotherapy, adjustments can be made in real-time to account for these changes, potentially making the treatment more effective. Currently, only a limited number of patients benefit from this technology using specialized machines. This study investigates whether similar benefits can be achieved using a standard machine, making this advanced treatment more accessible to a broader group of patients. Participants in this study will receive radiation therapy guided by a technique known as Cone Beam Computed Tomography (CBCT) on a standard Elekta machine. This approach allows the medical team to adapt each radiation session to the patient's current condition, potentially increasing the precision of the therapy. The study focuses on the feasibility of this method, meaning it will assess how practical and effective this approach is in a real-world setting. While the study does not specify the risks or benefits, adapting treatments in real-time could lead to better-targeted radiation, possibly enhancing outcomes for patients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
General Inclusion Criteria: * Patient, age ≥ 18 years, referred for a radiotherapy schedule as described in one of the cohorts. * WHO performance score 0-3. * Provision of signed, written and dated IC prior to any study specific procedures. Specific inclusion criteria for prostate cohort: * Accepted for radiotherapy of the prostate and pelvic lymph node areas. * Pathology-proven prostate cancer. * cT1-4 * cN1 on PSMA-PET/CT or pN1 based on node biopsy, SN-procedure or lymph node dissection. * cM0 on PSMA-PET/CT (except for patients with M1a disease who are still considered for radiotherapy of the prostate and pelvic lymph node areas). Specific inclusion criteria for cervical cohort: * Accepted for radiotherapy of the cervix (with or without chemotherapy) and pelvic lymph node areas (25 fractions, followed by either a brachytherapy or external radiotherapy boost). * Pathology-proven cervical cancer. * FIGO IIA2, IB3 and \> 6cm, IIB-IVA or N+. Or other stage and unfit for surgery. * cM0 or cM1 and accepted for locoregional radical (chemo)radiation in 25 fractions. Specific inclusion criteria for bladder cohort: * Accepted for radiotherapy of the bladder, either to the entire bladder or with a boost to the tumor area (with or without chemotherapy). * Pathology-proven bladder carcinoma. * cT1-4 * cN0 or cN1-2 after induction treatment (with or without lymph node dissection) Specific inclusion criteria for lung cohort: * Accepted for radiotherapy for lung cancer with lymph node metastases (with or without chemotherapy). * Non-small cell lung cancer (either pathology proven or enough clinical suspicion to warrant radiotherapy to primary tumor and pathologic lymph nodes. * cT1-4 and cN1-3. * M0 or m1 and accepted for radical radiotherapy in 24 fractions of 1 or more lymph node metastases and a primary tumor and/or pulmonary metastases. Specific inclusion criteria for head and neck cohort: * Accepted for radiotherapy for head and neck cancer (with or without chemotherapy). * Pathology-proven carcinoma of the pharynx, oral cavity or larynx. * cT1-4 * cN0-3 and indication for elective neck radiation (either 1 or 2 sides). * cM0 General Exclusion Criteria: * Patients who are pregnant. Specific for prostate cohort: * Patients with a medical condition that severely compromises CBCT image quality (mainly hip prostheses). * Severe lower urinary tract symptoms that could make the longer treatment time problematic (according to judgement of treating physician). Specific for cervical cohort: \- Patients with a medical condition that severely compromises CBCT image quality (mainly hip prostheses). Specific for bladder cohort: * Patients with a medical condition that severely compromises CBCT image quality (mainly hip prostheses). * Severe lower urinary tract symptoms that could make the longer treatment time problematic (according to judgement of treating physician). Specific for lung cohort: \- Severe pulmonary complaints that could make the longer treatment time problematic (according to judgement of treating physician). Specific for head and neck cohort: * Severe complaints that could make the longer treatment time problematic (according to judgement of treating physician). * Pulmonary fibrosis
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.5 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalGroup 5
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Antoni van Leeuwenhoek Hospital
Amsterdam, NetherlandsOpen Antoni van Leeuwenhoek Hospital in Google Maps