RecruitingNot ApplicableNCT07415356

Adaptive Fractionation in Online Adaptive Stereotactic Radiotherapy for Abdominopelvic Lymph Node Oligometastases


Sponsor

Joost J. M. E. Nuyttens

Enrollment

25 participants

Start Date

Feb 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Oligometastases, a state of cancer with up to five metastases, was traditionally treated with systemic treatments like chemotherapy. Treatment with stereotactic body radiotherapy (SBRT) showed 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. Unfortunately, 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 patients with abdominal or pelvic lymph node oligometastases.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria3

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONOnline-Adaptive SBRT

The treatment will consist of online-adaptive SBRT using the ETHOS linear accelerator. The standard treatment will be 45 Gy in 5 fractions (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 25 Gy in 1 fraction (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 made to verify the current treatment and improve future treatments.


Locations(1)

Erasmus MC

Rotterdam, South Holland, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07415356