Health TrialsbyHealthPanel

125I Seed Implantation Plus Systemic Therapy for Oligoprogressive NSCLC or Colorectal Cancer

ConditionOligometastatic Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLi Min

About this trial

Most patients with metastatic cancer eventually develop resistance to systemic therapy. A subset of patients experience oligoprogression, characterized by progression at a limited number of lesions while other disease sites remain controlled by ongoing systemic therapy. This randomized phase 2 trial evaluates whether image-guided 125I seed implantation targeting all oligoprogressive extracranial lesions, combined with standard-of-care systemic therapy, improves progression-free survival compared with standard-of-care systemic therapy alone in patients with metastatic NSCLC or CRC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Histologically or cytologically confirmed metastatic non-small cell lung cancer (NSCLC) or colorectal cancer (CRC).

Presence of metastatic disease with extracranial oligoprogression, defined as progression in up to five (≤5) individual lesions on CT or PET/CT imaging, while other known disease sites remain stable or controlled.

Received at least one prior line of standard systemic anticancer therapy, including maintenance therapy, for metastatic disease.

Disqualifiers

Pregnancy or breastfeeding.

Leptomeningeal disease or diffuse central nervous system involvement. Uncontrolled infection or serious medical comorbidities that, in the investigator's judgment, would preclude safe participation or interventional procedures.

Prior radiotherapy or brachytherapy requiring re-irradiation to the same tumor location planned for 125I seed implantation.

Known bleeding diathesis or uncorrectable coagulation disorders contraindicating interventional procedures.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard-of-Care Systemic Therapy

    Other intervention

    Standard systemic anticancer therapy administered according to current clinical guidelines and treating physician discretion, which may include chemotherapy, immunotherapy, targeted therapy, and/or maintenance therapy.

  • 125I Seed Implantation

    Procedure/Surgery

    Image-guided implantation of iodine-125 (125I) radioactive seeds to all extracranial oligoprogressive lesions for local tumor control, performed under CT or PET/CT guidance according to institutional standards.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Standard of Care (SOC)Active comparator 1 intervention
Group B: 125I Seed Implantation plus Standard of CareExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Progression-free survival is defined as the time from randomization to systemic disease progression or death from any cause, whichever occurs first. Disease progression will be assessed using RECIST version 1.1 and/or PERCIST criteria based on the baseline imaging modality.

Time frame
From randomization up to 12 months

Secondary outcomes

1

Overall Survival (OS)

Overall survival is defined as the time from randomization to death from any cause.

Time frame
From randomization up to 24 months
2

Time to Initiation of a New Systemic Therapy (TTNT)

Time to initiation of a new systemic therapy is defined as the time from randomization to the start of a new line or regimen of systemic anticancer therapy due to disease progression or clinical decision.

Time frame
From randomization up to 12 months
3

Local Control of Treated Lesions

Local control is defined as the absence of in-field progression of oligoprogressive lesions treated with 125I seed implantation, assessed on follow-up imaging.

Time frame
From intervention to 12 months after randomization
4

Safety and Treatment-Related Adverse Events

Safety is assessed by the incidence and severity of adverse events, including procedure-related toxicities, graded according to the Common Terminology Criteria for Adverse Events (CTCAE).

Time frame
From intervention through 12 months

Other outcomes

1

Metabolic Response on PET Imaging

Metabolic response on PET imaging is defined as the change from baseline in maximum standardized uptake value (SUVmax) of the target lesion, as measured on PET imaging at baseline and follow-up.

Time frame
Baseline and first scheduled imaging assessment (approximately 8 weeks after randomization)
2

Patterns of Disease Progression

Patterns of disease progression will be descriptively analyzed, including the development of new metastatic lesions versus progression of pre-existing lesions, based on radiographic and/or clinical assessment at the time of disease progression.

Time frame
From the date of randomization until the date of first documented disease progression, assessed up to 24 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Li Min

Lead sponsor

Jinan Military General Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: