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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Overall survival
Progression free survival
+1 more

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.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,422 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,287 Total Patients Enrolled
Chad TangPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
129 Total Patients Enrolled

Media Library

Local Consolidation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03599765 — Phase 2
Malignant Solid Neoplasm Research Study Groups: Arm II (routine therapy), Arm I (LCT, routine therapy)
Malignant Solid Neoplasm Clinical Trial 2023: Local Consolidation Therapy Highlights & Side Effects. Trial Name: NCT03599765 — Phase 2
Local Consolidation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03599765 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many hospitals is this research project being conducted?

"There are a total of 13 sites for this clinical trial, which are located in Sugar Land, Mansfield, Honolulu and other locations. If you want to participate in this trial, try to choose the location closest to you so that you won't have to travel far."

Answered by AI

Does Local Consolidation Therapy have the FDA's blessing?

"While Phase 2 trials don't have the efficacy data of a Phase 3, Local Consolidation Therapy received a safety score of 2."

Answered by AI

How many patients are included in this clinical trial?

"In order to complete this research, 367 participants who meet the pre-determined inclusion criteria are required. These patients can visit various locations such as MD Anderson in Sugar Land, Texas or OhioHealth Mansfield Hospital in Mansfield, Hawaii."

Answered by AI

Are new participants being enrolled in this clinical trial at this time?

"That is correct. The clinical trial in question is ongoing, and has been updated as recently as July 12th, 2022. Currently, 367 patients are needed to complete the study across 13 different sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Systemic Therapy With or Without Local Consolidative Therapy in Treating Patients With Oligometastatic Solid Tumor
2018. "Systemic Therapy With or Without Local Consolidative Therapy in Treating Patients With Oligometastatic Solid Tumor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03599765.
All > Hawaii
~85 spots leftby Dec 2025
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