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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-01-01

Brief Summary

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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.

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Detailed Description

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This is a prospective, open-label, randomized phase 2 controlled trial enrolling adults with histologically confirmed metastatic NSCLC or colorectal cancer who developed extracranial oligoprogression (≤5 progressive lesions) on PET/CT or CT while receiving at least first-line systemic therapy (including maintenance). Eligible patients will be randomized 1:1 to (1) standard-of-care systemic therapy per treating physician discretion, or (2) image-guided 125I seed implantation to all oligoprogressive lesions plus standard-of-care systemic therapy.

Oligoprogression will be determined by predefined imaging response criteria (RECIST and/or PERCIST, depending on baseline imaging modality), with confirmation by designated study radiologists. Follow-up imaging will be performed at 8 weeks (±2 weeks) after randomization and every 12 weeks (±2 weeks) thereafter to assess disease status. The primary endpoint is progression-free survival measured up to 12 months. Secondary endpoints include overall survival, time to initiation of a new systemic therapy, local control of implanted lesions, safety, and quality of life. Optional exploratory objectives may include circulating tumor DNA dynamics and metabolic PET parameters.

Conditions

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Oligometastatic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, parallel-assignment, open-label interventional study comparing standard-of-care systemic therapy alone with image-guided 125I seed implantation plus standard-of-care systemic therapy in patients with oligoprogressive metastatic non-small cell lung cancer or colorectal cancer.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care (SOC)

Participants receive standard-of-care systemic anticancer therapy per treating physician discretion, which may include chemotherapy, immunotherapy, targeted therapy, and/or maintenance therapy according to current clinical guidelines and individual molecular profiles.

Group Type ACTIVE_COMPARATOR

Standard-of-Care Systemic Therapy

Intervention Type OTHER

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 plus Standard of Care

Participants undergo image-guided 125I seed implantation to all extracranial oligoprogressive lesions, followed by continuation of standard-of-care systemic anticancer therapy as determined by the treating physician.

Group Type EXPERIMENTAL

Standard-of-Care Systemic Therapy

Intervention Type OTHER

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

Intervention Type PROCEDURE

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.

Interventions

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Standard-of-Care Systemic Therapy

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.

Intervention Type OTHER

125I Seed Implantation

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.
* All oligoprogressive lesions are technically feasible and considered safe for image-guided 125I seed implantation, as determined by the treating interventional team.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Adequate organ function to undergo interventional procedures and systemic therapy, per institutional standards.
* Ability to understand and willingness to sign written informed consent.

Exclusion Criteria

* 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.
* Any other condition that, in the investigator's judgment, would make the patient unsuitable for the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No