Clinical trial NCT06691776: FeASibility of Cbct-guIded ONline Adaptive RadioThErapy
Official title: FASCINATE: FeASibility of Cbct-guIded ONline Adaptive RadioThErapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Cervical Cancer
Bladder Cancer
Lung Cancer
Head and Neck Cancer
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Feasibility: successful application of the online adaptive treatment in 90% of 20 patients
timeFrame: From first fraction until the last fraction, an average of 20-35 fractions
Secondary outcomes:
measure: Safety: Treatment associated ≥ grade 3 acute toxicity according to the NCI Common Terminology Criteria of Adverse Events (CTCAE version 5.0).
timeFrame: From Baseline until 3 months after the last radiotherapy fraction
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek Hospital
Study officials:
References: