Adaptive high-precision radiation for abdominopelvic lymph node oligometastases
Adaptive Fractionation in Online Adaptive Stereotactic Radiotherapy for Abdominopelvic Lymph Node Oligometastases
This trial will try giving adapted high-dose, fewer-session targeted radiation (online adaptive SBRT) to adults with up to five abdominal or pelvic lymph node metastases to shorten treatment time while protecting nearby organs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT07415356 on ClinicalTrials.gov |
What this trial studies
This interventional approach uses online adaptive stereotactic body radiotherapy (SBRT) that adjusts the daily treatment plan to the patient's anatomy to better spare nearby radiosensitive organs such as the bowel. To counter the longer delivery time required for adaptive planning, the protocol tests increasing the dose per fraction and reducing the number of fractions (adaptive fractionation). Eligible patients have up to five metastatic lesions in no more than two organs, a controlled primary tumor, and recent PET or CT imaging. Treatments are delivered at Erasmus MC with close imaging-based planning and follow-up to monitor local control and toxicity.
Who should consider this trial
Good fit: Adults with abdominal or pelvic lymph node recurrences from solid tumors, no more than five metastases in up to two organs, a controlled primary site, recent PET/CT imaging, no prior radiotherapy to the same field, and who can give informed consent.
Not a fit: Patients with prior radiotherapy to the same area, widespread metastatic disease, an uncontrolled primary tumor, or serious comorbidities that limit safe treatment may not benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could shorten treatment visits while maintaining high tumor control and reducing radiation exposure to nearby organs, potentially delaying systemic therapy and its side effects.
How similar studies have performed: Conventional SBRT for oligometastases has shown high local control and improved disease-free survival in prior studies, but using online adaptive SBRT with increased per-fraction doses to shorten sessions is a newer approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rotterdam, South Holland
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.