125I Seed Implantation Plus Systemic Therapy for Oligoprogressive NSCLC or Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard-of-Care Systemic Therapy, 125I Seed Implantation.
- Who it may be relevant to
- Registry conditions: Oligometastatic Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Standard-of-Care Systemic Therapy With or Without Image-Guided 125I Seed Implantation in Patients With Oligoprogressive Metastatic Non-Small Cell Lung Cancer or Colorectal Cancer: An Open-Label, Randomized, Controlled Phase 2 Study
Overview
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.
Detailed description
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.
Interventions
- Other 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. - Procedure 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.
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: From randomization up to 12 months]
Secondary outcome measures (4)
- Overall Survival (OS) [Time frame: From randomization up to 24 months]
- Time to Initiation of a New Systemic Therapy (TTNT) [Time frame: From randomization up to 12 months]
- Local Control of Treated Lesions [Time frame: From intervention to 12 months after randomization]
- Safety and Treatment-Related Adverse Events [Time frame: From intervention through 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The 960th Hospital of People's Liberation Army (PLA) — Jinan
Identifiers
NCT: NCT07333651 · 960HP20251214