Genomic Tumor Board Review for Cancer

Not currently recruiting at 77 trial locations

Overseen By Dana Sparks

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Southwest Oncology Group

Disqualifiers: Hospice care

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special team of doctors and scientists, known as a genomic tumor board, can help select better treatments for certain cancer types. It focuses on patients whose solid tumors have returned, don't respond to treatment, have spread, or are advanced. The study compares the usual process of reviewing genomic test results, called a Genomic Profile, with the involvement of these experts. Patients with these cancer types who are expected to start new treatments soon might be suitable for the trial. As an unphased trial, it offers patients the opportunity to potentially benefit from personalized treatment strategies guided by expert insights.

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 is best to discuss this with your doctor to understand how your current treatments might interact with the study.

What prior data suggests that this educational intervention is safe?

Research has shown that the genomic tumor board (GTB) approach aids doctors in selecting better treatments based on genetic test results. No direct evidence from studies links the GTB process itself to risks, as it is not a drug or physical treatment. Instead, it helps doctors interpret genetic information from tumor tests to choose optimal treatment options.

This trial is labeled as "Not Applicable" in phase, indicating that the GTB focuses on improving decision-making rather than testing a new drug or therapy's safety and effectiveness. Thus, any safety concerns would relate to the treatments chosen after using the GTB, not the GTB process itself.

In summary, the GTB process enhances decision-making, and no known safety risks are associated with participating in this educational process. It is important to discuss any treatment options recommended by the GTB with a healthcare provider to understand potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Genomic Tumor Board Review for cancer because it offers a fresh approach to personalizing cancer treatment. Unlike standard care, where genomic test results are often reviewed by individual physicians, this method involves a structured Genomic Tumor Board (GTB) where experts discuss and interpret genomic data collectively. This collaborative approach enhances decision-making and helps prioritize treatment options more effectively. Additionally, the inclusion of educational materials supports both patients and physicians in understanding the genomic results, potentially leading to better-informed treatment decisions.

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

Research shows that a genomic tumor board (GTB) can help doctors make better treatment decisions for cancer patients. In this trial, participants in Arm 2 will receive the Educationally Enhanced Genomic Tumor Board (EGTB) intervention. A GTB—a team of experts—reviews and explains the genetic test results from tumors. This expert advice helps doctors find more personalized treatment options that might work better based on the tumor's genetic details. Studies have shown that doctors using GTBs feel more confident and informed about genetic testing. This approach could lead to more patients receiving treatments specifically targeted to their type of cancer. Meanwhile, participants in Arm 1 will receive usual care, where physicians order genomic tumor tests (GTT) and review the results without GTB involvement. ^{1 2 4 5 6}

Who Is on the Research Team?

Jens Rueter

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for adults with stage III or IV solid tumors that are recurrent, relapsed, refractory, metastatic, or newly diagnosed and advanced. Participants must be under the care of a study-enrolled physician and have genomic tumor tests ordered but not yet received results. They should not be on hospice care and must consent to participate.

Inclusion Criteria

My doctor ordered a genomic tumor test for me less than a week ago, and I'm waiting for the results.

Physician participants must be board-eligible or board-certified in Medical Oncology, Gynecologic Oncology, or Neurology

Participants must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria

Patient participants must not be going on hospice care at the time of registration

Recruitment Centers must not have or utilize an existing Genomic Tumor Board

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either usual care or the EGTB intervention, which includes genomic tumor board sessions and supporting education.

6 months

Weekly GTB sessions (virtual) for Arm 2

Follow-up

Participants are monitored for clinical outcomes, including survival and treatment discontinuation.

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Educational Intervention
• Genomic Profile
• Tumor Board Review

Trial Overview

The trial examines if an educationally enhanced genomic tumor board (EGTB) can increase genome-informed treatment in patients with serious solid tumors. It compares usual review methods of genomic test results against those reviewed by a GTB—a team experienced in interpreting genetic changes—to improve treatment decisions.

How Is the Trial Designed?

Group I: Arm 2 (EGTB) Experimental Treatment 6 Interventions

Patients and physicians receive the EGTB intervention. This is comprised of 2 components: the structured GTB and the supporting education. Physicians submit cases for discussion to the GTB within 2 weeks of GTT results. The GTB sessions are held weekly and conducted virtually over a video-conferencing platform. Each case presentation is 10 to 15 minutes long, and 4 to 6 cases are discussed during each 60 minute GTB session. GTT results and clinical data are presented and expert interpretation of genomic test results is provided to help prioritize potential treatment options and provide a framework for interpretation. Supporting education materials are also available online to participants to support GTT decision making.

Group II: Arm 1 (usual care) Active Control 5 Interventions

Participants receive usual care. This consists of physicians ordering GTT for patients and reviewing the results without the GTB being involved.

Who Is Running the Clinical Trial?

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The study evaluated the concordance of treatment recommendations from molecular tumor boards (MTBs) across 12 leading cancer institutions in Japan, finding an overall concordance rate of 62% with centrally developed consensus recommendations based on 50 simulated cancer cases.

Concordance was notably higher for cases with established biomarkers, such as colorectal cancer and ROS1 fusion (100%), while it was significantly lower for cervical cancer and cases with TP53 mutations, indicating a need for improved information sharing on treatments for genomic alterations with low evidence levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concordance Between Recommendations From Multidisciplinary Molecular Tumor Boards and Central Consensus for Cancer Treatment in Japan. Naito, Y., Sunami, K., Kage, H., et al.[2023]

The Breast Multidisciplinary Genomic Tumor Board (MGTB) effectively reviewed genomic test results for 40 metastatic breast cancer patients, primarily recommending clinical trials and FDA-approved therapies, showcasing the potential of multidisciplinary collaboration in cancer care.

While the MGTB provided more precise care recommendations, challenges included the limited actionability of genomic results and the dominance of medical oncologists in decision-making, highlighting areas for improvement in interdisciplinary contributions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"A rising tide lifts all boats": establishing a multidisciplinary genomic tumor board for breast cancer patients with advanced disease. McGowan, ML., Ponsaran, RS., Silverman, P., et al.[2018]

Molecular tumor boards (MTBs) in The Netherlands are consistently structured and show a high level of agreement (86%) in treatment recommendations for patients with rare or complex mutational cancer profiles, indicating their effectiveness in guiding targeted therapies.

The study suggests a 'Dutch MTB model' that promotes collaboration and data sharing among institutions, which could enhance the quality and consistency of treatment recommendations across different cancer centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter Comparison of Molecular Tumor Boards in The Netherlands: Definition, Composition, Methods, and Targeted Therapy Recommendations. Koopman, B., Groen, HJM., Ligtenberg, MJL., et al.[2021]

Precision cancer medicine focuses on individualized treatment based on specific gene alterations in tumors, which can significantly impact treatment effectiveness.

The establishment of a molecular tumor board (MTB) and clinical tumor board (CTB) system helps physicians interpret genetic profiling results and make informed treatment recommendations, addressing the challenge of integrating genetic information into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of Cancer Genomic Board and Preparation of Genomic Report]. Nakamura, K., Nishihara, H.[2020]

A systematic review of 14 studies involving 3,328 cancer patients indicated that molecular tumor board (MTB) reviews can lead to improved clinical outcomes, particularly for patients with limited standard treatment options.

In a controlled trial, patients receiving therapy recommended by the MTB showed significantly better progression-free survival compared to those on conventional therapies, suggesting that MTB recommendations may enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Molecular Tumor Boards: A Systematic Review. Larson, KL., Huang, B., Weiss, HL., et al.[2022]

In a study involving 43 patients with advanced breast cancer, 93% had at least one actionable genetic mutation identified through genomic profiling, highlighting the potential for personalized treatment options.

Of the patients discussed in the Molecular Tumor Board, 16% were treated based on the findings, with 41% of those achieving stable disease or partial remission, indicating that multidisciplinary approaches can enhance treatment strategies, though access to targeted therapies remains a significant barrier.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer Experience of the Molecular Tumor Board at the University of California, San Diego Moores Cancer Center. Parker, BA., Schwaederlé, M., Scur, MD., et al.[2022]

A community-based molecular tumor board (MTB) effectively processed genomic profiling results for 613 cancer patients, providing 837 actionable treatment recommendations, including standard therapies and clinical trials.

Implementation rates of these recommendations were significant, with 36% to 78% being followed by physicians, and 13% of patients enrolling in clinical trials based on MTB suggestions, demonstrating the MTB's role in enhancing patient management in advanced cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishment of a Molecular Tumor Board (MTB) and Uptake of Recommendations in a Community Setting. VanderWalde, A., Grothey, A., Vaena, D., et al.[2020]

A study involving 58 community oncology physicians revealed that while they generally have moderate confidence in using large-panel genomic tumor testing (GTT), they feel less confident about patients' understanding of test results and accessing targeted treatments.

Clinicians' intentions to use GTT in the future are linked to their confidence in using the tests and their perceptions of barriers to implementation, rather than their attitudes towards the value of GTT, indicating a need for further research on factors influencing GTT adoption in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community oncologists' perceptions and utilization of large-panel genomic tumor testing. Anderson, EC., Hinton, AC., Lary, CW., et al.[2023]

A study involving 12 patients highlighted significant gaps in understanding tumor genomic testing (TGT), particularly among lower-income and minority groups, indicating a need for better education on the subject.

To address these gaps, a concise animated video was developed to improve patient education about TGT, covering its implications for treatment, the testing process, insurance coverage, and the potential for incidental germline findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Understanding of Tumor Genomic Testing: A Quality Improvement Effort. Senter, L., Veney, D., Surplus, T., et al.[2023]

In a study involving 328 cancer patients discussed in multidisciplinary tumor boards (MTBs), 60.7% of cases resulted in a recommended change in clinical management, highlighting the significant impact of MTBs on treatment decisions.

Compliance with MTB recommendations for changing clinical management was 58.5%, indicating that while MTBs provide valuable insights into targeted therapies, there is still room for improvement in implementing these recommendations in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Molecular Tumor Board on the Clinical Management of Patients With Cancer. Behel, V., Noronha, V., Choughule, A., et al.[2022]

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This study compares the usual approach to reviewing genomic tumor test results with the approach of having a genomic tumor board (GTB) review the test results.