Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06691776

Feasibility of CBCT-Guided Online Adaptive Radiotherapy (FASCINATE)

Led by The Netherlands Cancer Institute · Updated on 2025-08-01

100

Participants Needed

1

Research Sites

274 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Feasibility of CBCT-Guided Online Adaptive Radiotherapy (FASCINATE)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 18 years or older and referred for radiotherapy in one of the specified cancer cohorts.
  • WHO performance score between 0 and 3.
  • Signed, written, and dated informed consent provided before study procedures.
  • For prostate cancer: pathology-proven prostate cancer, clinical stages cT1-4, cN1 on PSMA-PET/CT or node biopsy, cM0 (except some M1a cases), and accepted for prostate and pelvic lymph node radiotherapy.
  • For cervical cancer: pathology-proven cervical cancer, stages FIGO IIA2, IB3 > 6cm, IIB-IVA or N+, or unfit for surgery, cM0 or cM1 accepted for locoregional radical (chemo)radiation, and accepted for cervix and pelvic lymph node radiotherapy.
  • For bladder cancer: pathology-proven bladder carcinoma, clinical stages cT1-4, cN0 or cN1-2 after induction treatment, accepted for bladder radiotherapy with or without chemotherapy.
  • For lung cancer: non-small cell lung cancer with lymph node metastases, clinical stages cT1-4 and cN1-3, M0 or m1, accepted for radical radiotherapy in 24 fractions.
  • For head and neck cancer: pathology-proven carcinoma of pharynx, oral cavity or larynx, clinical stages cT1-4, cN0-3 with elective neck radiation indication, cM0, accepted for radiotherapy with or without chemotherapy.
Not Eligible

You will not qualify if you...

  • Pregnancy.
  • For prostate, cervical, and bladder cohorts: medical conditions severely compromising CBCT image quality, mainly hip prostheses.
  • For prostate and bladder cohorts: severe lower urinary tract symptoms that could complicate longer treatment time.
  • For lung cohort: severe pulmonary complaints that could complicate longer treatment time.
  • For head and neck cohort: severe complaints that could complicate longer treatment time and pulmonary fibrosis.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands

Actively Recruiting

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Research Team

E

Evelien Schouten, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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