Long-term assessment of local therapy for oligometastatic disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This national multicenter observational and interventional study evaluates the disease trajectory of patients with oligometastatic disease (OMD) receiving local metastasis-directed therapy. It includes various treatment modalities such as surgical metastasectomy, radiotherapy, thermal ablation, and electroporation for patients with any non-hematological cancer. The study aims to assess the effectiveness of these therapies over time and create a prediction model for patient selection. Both observational and interventional cohorts will be included to gather comprehensive data on treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histology or cytology proven non-haematological cancer
* Stage IV disease
* ECOG performance status ≤ 2
* Life expectancy \> 6 months
* A baseline scan within 42 days of inclusion (PET-CT or CT or MRI scan) is required, preferably within 28 days for optimal prospective evaluation
* Primary tumor must be controlled, defined by the radiographical response of the primary tumor by systemic or local treatment. If progressing, it is planned to be treated with local ablative therapy (LAT)
* Oligometastatic disease according to the ESTRO-EORTC classification, both de-novo and induced, including oligoprogression
* A maximum of five oligometastases or oligopersistent/oligoprogressive lesions. More than five metastases are allowed in the following cases, 1) location in a defined anatomical entity or 2) location in immediate proximity and as such, cannot be treated separately
* All oligometastatic lesions must be planned for definitive LAT. If all visible/progressive/persistent disease is not treated, the patient cannot be included
* Local ablative therapy must be deemed clinically relevant for the individual patient by the treating team of physicians, or a multidisciplinary team and discussion must be documented in the patient chart
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Pregnancy
* Diffuse cancer disease, which cannot be locally ablated, i.e., leptomeningeal carcinomatosis, malignant pleural effusions, lymphangitic carcinomatosis, or peritoneal carcinomatosis
* If LAT is deemed unsafe by the MDT (e.g., tumor perforation of hollow organs)

In addition, the patients receiving SBRT to oligometastatic sites should comply with the following criteria.

* The size of the target is limited by the ability to safely deliver locally ablative doses to the metastatic lesions. Generally, an upper limit of 5 cm is recommended
* If the patient has received previous radiotherapy, the combined dose at the radiation site must not exceed the dose constraints according to Appendix 2 - Radiotherapy Recommendations

Where it's running

• Copenhagen University Hospital Herlev and Gentofte
  Herlev, Capital Region of Denmark, Denmark Recruiting
• Copenhagen University Hospital Rigshospitalet
  Copenhagen, Capital Region of Denmark, Denmark Not yet recruiting
• Hillerød Hospital
  Hillerød, Capital Region of Denmark, Denmark Not yet recruiting
• Aarhus University Hospital
  Aarhus, Central Jutland, Denmark Not yet recruiting
• Gødstrup Hospital
  Herning, Central Jutland, Denmark Not yet recruiting
• Danish Center for Particle Therapy
  Aarhus, Central Region Denmark, Denmark Not yet recruiting

Study contacts

• Principal investigator: Michael RT Laursen, MD — Copenhagen University Hospital Herlev and Gentofte
• Study coordinator: Michael RT Laursen, MD
• Email: michael.ruben.teindl.laursen@regionh.dk
• Phone: +45 3868 9202

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment for patients with oligometastatic esophageal cancer using PD-1 inhibitors and local therapy

  This study is testing if adding local treatments like surgery or radiation to a PD-1 inhibitor and chemotherapy can help people with oligometastatic esophageal cancer live longer without their cancer getting worse.

  Recruiting Phase 3 Fudan University · Shanghai · NCT06190782

• Analysis of outcomes and side effects in patients receiving radiation therapy

  This study looks at the results and side effects of radiation therapy in patients at Winterthur Cantonal Hospital to see how treatment can be improved for future patients.

  Recruiting Kantonsspital Winterthur KSW · Winterthur, Canton of Zurich · NCT05192876

• Primary tumor removal with targeted lymph node removal plus radiation for biliary tract cancer with lymph node spread

  This phase II study tests whether removing the main tumor and select nearby lymph nodes, followed by postoperative radiation, helps patients with biliary tract cancer and lymph node metastases.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07893392

• Tributyrin as a dietary supplement to help prevent radiation-induced rectal injury during rectal cancer chemoradiation

  This study tests whether adding tributyrin to standard chemoradiotherapy helps prevent acute radiation-induced rectal injury in people with locally advanced rectal cancer.

  Recruiting Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT07802002

• Targeted Induction Therapy for Stage III Unresectable EGFR Mutant NSCLC

  This trial tests a targeted induction approach using fumetinib with platinum-based chemotherapy and concurrent radiochemotherapy in adults with unresectable stage III EGFR-mutant NSCLC to see if this combo can improve outcomes before possible surgery.

  Recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07742332

• Virtual vs in-person follow-up visits after radiotherapy

  This study tests whether telehealth follow-ups during radiotherapy are practical and satisfactory for patients and physicians, compared to in-person visits.

  Recruiting Shaukat Khanum Memorial Cancer Hospital & Research Centre · Lahore, Punjab Province · NCT07724548

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.