Online adaptive radiation therapy for various cancers
FASCINATE: FeASibility of Cbct-guIded oNline Adaptive radioThErapy
This study is testing if using real-time adjustments in radiation therapy can help improve treatment for adults with prostate, cervical, bladder, lung, and head and neck cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06691776 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of using online CBCT-guided adaptive radiation therapy on a standard Elekta linear accelerator for patients with prostate, cervical, bladder, lung, and head and neck cancers. The approach focuses on correcting geometric uncertainties and changes that occur between radiotherapy fractions, which could enhance the accuracy of treatment. By adapting the therapy in real-time, the study seeks to improve outcomes for patients who are currently treated on standard equipment. The research will involve patients aged 18 and older who meet specific eligibility criteria related to their cancer type and treatment plan.
Who should consider this trial
Good fit: Ideal candidates include adults with prostate, cervical, bladder, lung, or head and neck cancers who are scheduled for radiotherapy and meet specific inclusion criteria.
Not a fit: Patients with cancer types not included in the study or those who are not eligible for radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the precision and effectiveness of radiation therapy for various cancer types.
How similar studies have performed: While online adaptive radiation therapy is being explored, this specific approach using a standard Elekta linac is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam
- Antoni van Leeuwenhoek Hospital — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Evelien Schouten, MSc
- Email: ev.schouten@nki.nl
- Phone: +31205129140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.