Primary: Can the number of online adaptive fractions be reduced by 30%?Secondary: What is the overall survival, local control, and toxicity? What is the movement of the bowel during treatment? Is there added value in re-aligning the patient when…
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction of the average number of fractions by 30%, by using online adaptive
stereotactic radiotherapy for patients with lymph node oligometastases in the
abdomen or pelvis.
Secondary outcome
Total survival duration, local control, toxicity, bowel movement during
treatment via CBCT scans, and the impact of realigning the patient if excessive
movement occurs during treatment.
Background summary
Oligometastases, a state of cancer with up to five metastases, was
traditionally treated with systemic treatments like chemotherapy. Stereotactic
body radiotherapy (SBRT) did show a high local control and improved
disease-free survival.
The use of SBRT also allows for the deferral of systemic treatment, thereby
delaying its potential side effects. SBRT enables the delivery of a high dose
to the tumor while minimizing the dose to organs at risk, reducing normal
tissue damage. However, toxicity remains a potential issue in the
abdominopelvic region, where lymph node oligometastases are often located near,
highly mobile, radiosensitive organs like the bowel.
Online adaptive radiotherapy is used to address this issue, adapting the
treatment plan to the anatomy of the day. However, adaptive radiotherapy
results in longer treatment delivery times than conventional radiotherapy. This
can potentially be countered by increasing the fraction dose and reducing the
number of fractions if the patient anatomy allows it. This is convenient for
the patient as it reduces the number of hospital visits, and it could also
reduce the total workload for the hospital. Therefore, there is not only a
benefit of a reduction in toxicity by adaptive treatment, but also in reducing
the total treatment time. This study aims to investigate if the number of
adaptive fractions can be reduced by 30% for our study population.
Study objective
Primary: Can the number of online adaptive fractions be reduced by 30%?
Secondary: What is the overall survival, local control, and toxicity? What is
the movement of the bowel during treatment? Is there added value in re-aligning
the patient when there has been excessive movement?
Study design
Phase II, single arm, non randomised clinical trial.
Intervention
The treatment will consist of online-adaptive SBRT using the ETHOS linear
accelerator. The standard treatment will be 45Gy/5Fx. If the patient anatomy
allows, the number of planned fractions will be isotoxically reduced, keeping
OAR and target dose goals biologically equivalent, to a minimum of 25Gy/1Fx.
For the adaptive treatment, daily HyperSight CBCT scans will be made, and the
target and OAR contours will be automatically delineated and adjusted if
necessary. If, during treatment, patient anatomy changes in such a way that
fewer or more fractions are required than planned, changes can be made in the
daily dose and number of remaining fractions. During and after treatment a CBCT
scan is also made to verify current and improve future treatments.
Study burden and risks
Patients may experience early symptoms such as pain, nausea, vomiting,
diarrhea, and bleeding, as well as late toxicity symptoms like chronic pain,
diarrhea, stenosis, and fistulas. The treatment is delivered in 1 to 5
fractions. For all patients, the risk of toxicity will be significantly reduced
by the implementation of adaptive treatment, due to the re-optimization of
plans based on the patient anatomy. The treatment with the reduced number of
fractions, while conventionally posing a higher risk of side effects, reduces
the treatment burden as patients need to visit the hospital only once. It
should be noted that the constraints for the organs at risk are isotoxic and
are always prioritised over the target.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Patients with abdominal and/or pelvic lymph node recurrences of solid tumors.
No more than 5 metastatic lesions in no more than 2 organs and a controlled
primary tumor site.
Diagnostic imaging includes at least a PET scan or CT thorax/abdomen, of which
one is not older than 4 weeks at the time of referral for SBRT.
Primary tumor must be treated at least 4 months before the diagnosis of
metastasis.
Patients must be 18 years or older.
Written informed consent
Exclusion criteria
Prior radiotherapy in the same field.
Second primary malignancy except in situ carcinoma of the cervix, adequately
treated non-melanoma skin cancer, or other malignancy treated at least 3 years.
Serious concomitant systemic disorders that would compromise the safety of the
patient or his/her ability to complete the study, at the discretion of the
investigator.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87228.078.24 |