Feasibility of CBCT-Guided Online Adaptive Radiotherapy (FASCINATE) (FASCINATE)

FASCINATE: FeASibility of Cbct-guIded oNline Adaptive radioThErapy

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; Head and Neck Cancer; Lung Cancer; Prostate Cancer; Bladder Cancer
• Intervention / Treatment: Device: online CBCT-guided adaptive radiation therapy using a new software

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evelien Schouten, MSc; Phone Number: +31205129140; Email: ev.schouten@nki.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Antoni van Leeuwenhoek Hospital
    • Contact: Z Gouw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adapt to rotation for prostate and elective lymph node irradiation; 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; 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.
Experimental: CBCT-guided online adaptation for cervical cancer and elective lymph node irradiation; 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; 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.
Experimental: CBCT-guided online adaptation for bladder cancer.; 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; 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.
Experimental: CBCT-guided online adaptation for lung cancer; 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; 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.
Experimental: CBCT-guided online adaptation for head and neck cancer; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: N23FAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No