Feasibility of CBCT-Guided Online Adaptive Radiotherapy (FASCINATE)

NCT06691776 | Recruiting

• 1 other identifier: N23FAS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The accuracy of radiotherapy can be increased by correcting for geometric uncertainties and changes between radiotherapy fractions. These corrections are currently done with online adaptive treatment on a specialized linear accelerator (linac) for a small subset of patients. However, patients currently treated on a standard linac could also benefit from online adaptive radiotherapy. The objective is to determine the feasibility of online CBCT-guided adaptive radiation therapy on a standard Elekta linac.

Conditions

Prostate Cancer; Cervical Cancer; Bladder Cancer; Lung Cancer; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility: successful application of the online adaptive treatment in 90% of 20 patients

  The adaptive treatment is feasible if the technique is successfully ap-plied in 90% of 20 patients.

  From first fraction until the last fraction, an average of 20-35 fractions

Secondary Outcomes (1)

• Safety: Treatment associated ≥ grade 3 acute toxicity according to the NCI Common Terminology Criteria of Adverse Events (CTCAE version 5.0).

  From Baseline until 3 months after the last radiotherapy fraction

Study Arms (5)

Adapt to rotation for prostate and elective lymph node irradiation

EXPERIMENTAL

The CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. A new software (the rotation simulator) reads both the match of the bony anatomy and the match of the prostate. This software also imports the original planning CT and structures and deforms the original planning CT to match the rotations and translations of pelvis and prostate, as seen in the CBCT. Both these new radiotherapy planning structures and the deformed planning CT are exported to the radiotherapy planning software (Monaco) and used to calculate the adaptive plan. This newly calculated plan will be exported to Mosaiq to treat the patient.

Device: online CBCT-guided adaptive radiation therapy using a new software

CBCT-guided online adaptation for cervical cancer and elective lymph node irradiation

EXPERIMENTAL

The CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. With in-house software, the target areas and the OARs will be deformed to or segmented on the anatomy of the CBCT. These adjusted radiotherapy structures are then send to the radiotherapy planning software (Monaco). There, the structures are visually inspected and, if needed, manually adjusted. Afterwards, Monaco calculates a new, online adaptive radiotherapy plan. After checking, the plan is exported to Mosaiq to treat the patient.

Device: online CBCT-guided adaptive radiation therapy using a new software

CBCT-guided online adaptation for bladder cancer.

EXPERIMENTAL

The CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. With in-house software, the target areas and the OARs will be deformed or segmented to the anatomy of the CBCT. These adjusted radiotherapy structures are then send to the radiotherapy planning software (Monaco). There, the structures are visually inspected and, if needed, manually adjusted. Afterwards, Monaco calculates a new, online adaptive radiotherapy plan. After checking, the plan is exported to Mosaiq to treat the patient.

Device: online CBCT-guided adaptive radiation therapy using a new software

CBCT-guided online adaptation for lung cancer

EXPERIMENTAL

The CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. The rotation simulator reads both the registration of the primary tumor and of the lymph nodes (via the carina). This software also imports the original planning CT and structures and deforms the original planning CT to match the rotations and translations of the primary tumor and lymph nodes, as seen in the CBCT. Both these new radiotherapy planning structures and the deformed planning CT are exported to the radiotherapy planning software (Monaco) and used to calculate the adaptive plan. This newly calculated plan will be exported to Mosaiq to treat the patient.

Device: online CBCT-guided adaptive radiation therapy using a new software

CBCT-guided online adaptation for head and neck cancer

EXPERIMENTAL

The CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. The rotation simulator reads the image registration of the primary tumor and the match of the lymph node areas. This software also imports the original planning CT and structures and deforms the original planning CT to match the rotations and translations of the primary tumor and lymph node areas, as seen in the CBCT. Both these new radiotherapy planning structures and the deformed planning CT are exported to the radiotherapy planning software (Monaco) and used to calculate the adaptive plan. This newly calculated plan will be exported to Mosaiq to treat the patient.

Device: online CBCT-guided adaptive radiation therapy using a new software

Interventions

online CBCT-guided adaptive radiation therapy using a new software DEVICE

Patients are treated in the NKI with CBCT-guided online adaptive radiotherapy. While in the clinical workflow one planning CT is used to make the radiotherapy plan, this study treatment creates a new radiotherapy plan on the day of every treatment fraction. Instead of directly irradiating, the radiotherapy plan is adjusted to the anatomy of the day.

Adapt to rotation for prostate and elective lymph node irradiation; CBCT-guided online adaptation for bladder cancer.; CBCT-guided online adaptation for cervical cancer and elective lymph node irradiation; CBCT-guided online adaptation for head and neck cancer; CBCT-guided online adaptation for lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Uterine Cervical Neoplasms; Urinary Bladder Neoplasms; Lung Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Evelien Schouten, MSc

CONTACT

+31205129140; ev.schouten@nki.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, non-randomized basket trial of the technical feasibility and safety of new software/technologies for CBCT-guided online adaptive radiotherapy. Patients will be enrolled in multiple parallel cohorts, each defined by tumor type(s), and a technical design for the online adaptation.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: November 15, 2024
• Study Start: August 29, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)