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Systemic vs Local Consolidative Therapy for Metastatic Cancer

Phase 2

Waitlist Available

Led By Chad Tang

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Oligometastatic solid tumors patients (=< 5 metastatic lesions at the time of study entry)

Must not have

Diffuse metastatic processes including leptomeningeal disease, diffuse bone marrow involvement, and peritoneal carcinomatous, which by the discretion of the treating physician cannot be treated definitively

In the event that a curative systemic option exists for metastatic disease from a given disease site. First-line metastatic patients (those patients who have had no prior lines of systemic therapy targeting their metastatic disease) are only eligible for enrollment if they have completed their curative systemic therapy per the judgment of the treating oncologist and have persistent disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well systemic therapy works with or without local consolidative therapy to treat patients with solid tumors that have spread to other parts of the body. Treatment with up-front local consolidative therapy may be more effective in controlling the disease.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, side effects may include typical reactions from systemic therapies like nausea and fatigue as well as potential risks associated with localized treatments such as pain or discomfort at treatment sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have 5 or fewer cancer spread sites.

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I have had 4 or fewer treatments for my cancer that has spread.

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My cancer diagnosis has been confirmed by lab tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I've completed all possible curative treatments for my metastatic disease as advised by my oncologist, but still have the disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (routine therapy)Experimental Treatment1 Intervention

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

Group II: Arm I (LCT, routine therapy)Experimental Treatment2 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.

0 / 6Eligibility criteria met