Systemic vs Local Consolidative Therapy for Metastatic Cancer

Not currently recruiting at 12 trial locations

Overseen By Chad Tang

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Scleroderma, Lupus, Metastatic effusion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding local treatments, such as surgery or targeted therapies (known as Local Consolidation Therapy), to regular drug therapy can better manage cancer that has spread to one other area in the body. It targets individuals with solid tumors that have spread to five or fewer spots. Participants should have tried no more than four different drug treatments for their cancer and must be eligible for local treatments at all active disease sites. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that local consolidative therapy (LCT) is usually well-tolerated. This treatment includes options like surgery, cryotherapy (freezing cancer cells), and radiofrequency ablation (using heat to destroy cancer cells). Although detailed safety information is limited, past studies suggest these methods can be as effective and safe as traditional treatments.

For instance, studies have found that radiotherapy, a common component of LCT, can improve patient outcomes without significantly increasing side effects. While the data does not reveal any major safety concerns, individual experiences can vary. It is always important to discuss with a doctor what to expect and any potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores the potential benefits of combining Local Consolidation Therapy (LCT) with routine drug therapy for metastatic cancer. Unlike standard treatments that primarily rely on systemic drug therapy, LCT directly targets tumors through methods like surgical resection, cryotherapy, and radiofrequency ablation. This approach could potentially enhance treatment effectiveness by reducing tumor size locally and limiting the spread of cancer, while still allowing for the benefits of systemic therapies. By integrating these strategies, researchers hope to improve patient outcomes and offer a more comprehensive approach to managing metastatic cancer.

What evidence suggests that this trial's treatments could be effective for metastatic cancer?

Research has shown that local consolidative therapy (LCT), which participants in this trial may receive, can effectively treat cancer that has spread to other parts of the body. In one study, patients who received LCT lived longer without their cancer worsening, with a median time of 32.8 months compared to 14.5 months for those who did not receive LCT. Another study found that patients who had LCT lived longer overall, with a median survival time of 41.2 months. LCT has also improved survival in patients with certain types of cancer, such as non-small cell lung cancer, when used after initial treatments. These findings suggest that LCT can help control cancer and extend life in patients with metastatic disease. ^{4 5 6 7 8}

Who Is on the Research Team?

Chad Tang

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with a solid tumor that has spread to no more than 5 other sites (oligometastatic). They should have had fewer than 4 prior systemic treatments, be able to undergo local therapy, and have an ECOG performance status of 0-2. Key blood and liver function levels must meet specific criteria. Those with certain rheumatologic diseases, diffuse metastases, psychiatric or substance abuse issues, pregnant women, or those at risk of pregnancy are excluded.

Inclusion Criteria

My liver function tests are within the required limits.

Hemoglobin >=7 g/dL (performed within 6 weeks prior to study enrollment)

I am able to get out of my bed or chair and move around.

Exclusion Criteria

My cancer has spread widely and cannot be fully treated, according to my doctor.

Is pregnant or expecting to conceive within the projected duration of the trial at the screening visit

Additional diagnosis of another primary malignancy outside of the malignancy being treated on trial that per the discretion of the treating physicians and investigational team offers a substantial risk to the patient's life (e.g. primary lung cancer definitively treated in the past 6 months would offer a significant risk to the patient's life, while a basal cell carcinoma treated with local excision would not)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive up-front standard of care LCT including surgical resection, cryotherapy, and radiofrequency ablation, followed by routine drug therapy

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 18 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Local Consolidation Therapy

Trial Overview The study is examining the effectiveness of standard systemic therapy alone versus combined with local consolidative therapy in controlling cancer that has spread but remains limited in number. The goal is to determine if adding targeted treatment directly to each cancer site can better manage the disease.

How Is the Trial Designed?

Group I: Arm II (routine therapy) Experimental Treatment 1 Intervention

Patients receive routine drug therapy. Patients may later receive LCT at the discretion of doctor.

Group II: Arm I (LCT, routine therapy) Experimental Treatment 2 Interventions

Patients receive up-front standard of care LCT including but not limited to surgical resection, cryotherapy, and radiofrequency ablation. Patients then receive routine drug therapy.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 194 patients with synchronous oligometastatic non-small-cell lung cancer (NSCLC), comprehensive local consolidative therapy (LCT) was linked to improved overall survival, with a hazard ratio of 0.67, indicating a significant benefit for patients receiving treatment to all sites of disease.

The greatest survival benefits from comprehensive LCT were observed in patients without thoracic nodal disease or bone metastases, suggesting that the effectiveness of LCT may vary based on the extent and location of metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Overall Survival With Comprehensive Local Consolidative Therapy in Synchronous Oligometastatic Non-Small-Cell Lung Cancer. Mitchell, KG., Farooqi, A., Ludmir, EB., et al.[2021]

In a study of 436 patients with oligometastatic non-small cell lung cancer, local consolidative treatment (LCT) significantly improved overall survival (OS) in most risk groups, highlighting its potential efficacy in this patient population.

However, smokers with advanced T3/4 disease did not show a survival benefit from LCT, suggesting that the effectiveness of this treatment may vary based on specific patient characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recursive partitioning analysis of patients with oligometastatic non-small cell lung cancer: a retrospective study. Zhang, JT., Liu, SY., Yan, HH., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10092956/

Local Consolidative Therapy May Have Prominent Clinical ... Patients with LCT had a significantly better PFS than those without LCT (median PFS: 32.8 vs. 14.5 months, p = 0.0008; Figure 2a). More than half of the ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.19.00201

Local Consolidative Therapy Vs. Maintenance ... Patients originally assigned to LCT had prolonged OS times (median OS, 41.2 months) and durable survival after progression (37.6 months). These ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949713225000096

Efficacy of local consolidative radiotherapy with first-line ... Patients diagnosed with metastatic disease have a poor prognosis, with a 5-year survival rate of 5%. Notably, oligometastatic disease (OMD) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10652880/

Survival benefit of local consolidative therapy for patients ... Notably, 31 patients who underwent surgery in combination with radiotherapy had the best survival outcomes than those who received surgery or ...

5. cancerbiomed.org cancerbiomed.org/content/early/2025/01/07/j.issn.2095-3941.2024.0456

Local consolidative therapy in oligometastatic non-small- ... LCT for oligometastatic NSCLC after induced systemic therapy has been reported to improve survival in patients with advanced NSCLC and oligo-residual disease.

6. nature.com nature.com/articles/s41598-025-20679-2

Local consolidative therapy extends survival in metastatic ... Ablation therapy has been shown to enhance outcomes in mNSCLC and is considered comparable to surgical resection in efficacy for early-stage ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31067138/

Local Consolidative Therapy Vs. Maintenance ... - PubMed Purpose: Our previously published findings reported that local consolidative therapy (LCT) with radiotherapy or surgery improved progression- ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11470411/

Safety and efficacy of consolidative stereotactic radiotherapy ... Prospective data is limited on the efficacy and safety of consolidative stereotactic radiotherapy (SRT) in metastatic epidermal growth factor ...