Use of a Genomic Tumor Board to Increase the Number of Patients with Recurrent, Refractory, Metastatic, or Newly Diagnosed Advanced Solid Tumors who Receive Genome-Informed Treatment

Active:	Yes
Cancer Type:	Solid Tumor Unknown Primary	NCT ID:	NCT05455606
Trial Phases:		Protocol IDs:	S2108CD (primary) S2108CD SWOG-S2108CD NCI-2022-04626
Eligibility:	18 Years and older, Male and Female	Study Type:	Health services research
Study Sponsor:	SWOG
NCI Full Details:	http://clinicaltrials.gov/show/NCT05455606

Summary

This clinical trial determines whether an educationally enhanced genomic tumor board (EGTB) intervention increases the proportion of patients with solid tumor who receive genome-informed treatment for tumor that has come back after a period of improvement (recurrent), does not respond to treatment (refractory), has spread from where it started (primary site) to other places in the body (metastatic), or is newly diagnosed and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). This trial also aims to learn whether EGTB intervention increases doctors’ understanding of genomic tumor test results as well as their comfort level with genomic tumor tests. Genome-informed treatment refers to treatment based on the information found in genomic tumor test results. This study compares the usual approach in which physicians order genomic tumor test and review the results without the genomic board (GTB) involvement versus when physicians receive guidance from genomic tumor board (GTB) after GTB reviews patients’ genomic test results. A GTB is team of doctors and scientists that have experience in understanding genomic changes. An educationally enhanced tumor board is a tumor board that provides additional training. The tumor board helps to suggest whether there are other cancer treatment options based on patient genetic test results.

Objectives

PRIMARY OBJECTIVE:
I. To determine whether an EGTB intervention compared to usual practice increases the proportion of patients who receive evidence-based genome-informed therapy within 6 months after registration to the study.

SECONDARY OBJECTIVES:
I. To compare physician genomic confidence and physician experience with genomic tumor testing (GTT) between arms at baseline and end of study.
II. To compare clinical outcomes between arms by assessing patient survival and time to treatment discontinuation.
III. To compare physician assessment of evidence-based genome-informed therapy to the central study team determination of evidence-based genome-informed therapy, both overall and separately by arm.

IMPLEMENTATION OBJECTIVES:
I. To assess the utilization of GTT and implementation of the EGTB intervention into clinic workflow in order to better understand barriers and facilitators at Recruitment Centers assigned to the active intervention arm using a mixed-methods approach.
II. To assess the evolution of GTT utilization within clinic workflows at Recruitment Centers assigned to the usual practice (control) arm using a mixed-methods approach.

OUTLINE: Study clinics are randomized to 1 of 2 arms. Participants receive interventions based on this randomization.

ARM 1: Participants receive usual care. This consists of physicians ordering GTT for patients and reviewing the results without the GTB being involved.

ARM 2: 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 9 cases are discussed during each 60 to 90 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.

Physicians are followed until the end of the study or through 6 months after their last patient was registered to the study, whichever is later. Patients are followed for 24 months after registration or until a criterion for removal from protocol participation is met, whichever comes first.

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