Systemic vs Local Consolidative Therapy for Metastatic Cancer

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

380 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Local Consolidation Therapy for metastatic cancer?

Research suggests that local treatments, like radiation therapy, can improve survival and control cancer spread when combined with systemic therapies in patients with limited metastases. This approach has shown promise in prolonging survival and increasing cure rates for certain types of metastatic cancers. ^{1 2 3 4 5}

Is local consolidative therapy safe for humans?

Local consolidative therapy, which often involves radiation, has been used in various cancers and is generally considered safe when applied correctly. It can help control cancer spread and may activate the immune system, but like any treatment, it can have side effects, so it's important to discuss potential risks with your doctor. ^{1 2 4 6 7}

How does Local Consolidation Therapy differ from other treatments for metastatic cancer?

Local Consolidation Therapy (LCT) is unique because it targets and treats all known sites of cancer spread with focused treatments like radiation, aiming to improve survival by controlling the disease locally. This approach is particularly beneficial for patients with oligometastatic cancer, where the cancer has spread to only a few sites, and it can be combined with systemic therapies to enhance overall treatment effectiveness. ^{1 2 3 8 9}

What is the purpose of this trial?

This phase II trial studies how well systemic therapy with or without local consolidative therapy work in treating patients with solid tumor that has spread to 1 site of other places in the body. Treatment with up-front local consolidative therapy may be better in helping to control the disease.

Research Team

Chad Tang

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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.

My liver function tests are within the required limits.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The oligometastatic spectrum in the era of improved detection and modern systemic therapy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Use of Multi-Site Radiation Therapy for Systemic Disease Control. [2023]

3. Hungary pubmed.ncbi.nlm.nih.gov

[Adjuvant chemotherapy of early stage breast cancer]. [2015]

4. Ireland pubmed.ncbi.nlm.nih.gov

Breast radiotherapy as part of loco-regional treatments in stage IV breast cancer patients with oligometastatic disease. [2010]

5. England pubmed.ncbi.nlm.nih.gov

The value of tumour debulking for patients with extensive multi-organ metastatic colorectal cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Definitive Local Consolidative Therapy for Oligometastatic Solid Tumors: Results From the Lead-in Phase of the Randomized Basket Trial EXTEND. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Additional local consolidative therapy has survival benefit over EGFR tyrosine kinase inhibitors alone in bone oligometastatic lung adenocarcinoma patients. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Recursive partitioning analysis of patients with oligometastatic non-small cell lung cancer: a retrospective study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Improved Overall Survival With Comprehensive Local Consolidative Therapy in Synchronous Oligometastatic Non-Small-Cell Lung Cancer. [2021]