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MET-4 with Chemoradiotherapy for Throat Cancer (ROMA LA-OPSCC2 Trial)

N/A

Waitlist Available

Led By Anna Spreafico, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Patient must be willing and able to provide: -Oropharyngeal swab, stool and blood specimen at protocol specified time points.

Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the oropharynx (soft palate, tonsils, base of tongue).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trialinvestigates if adding a bacterial strain, MET-4, to chemoradiotherapy is safe, tolerable and effective for treating a type of throat cancer. It involves 30 patients and will take 12 months.

Who is the study for?

This trial is for adults over 18 with a specific throat cancer (Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma) who can undergo standard chemoradiotherapy. Participants must be able to provide various biological samples and have no conditions affecting study safety or results interpretation, such as gastrointestinal disorders that impact medication absorption.

What is being tested?

The trial tests the safety and effects of MET-4 bacteria strains alongside usual chemoradiotherapy in treating throat cancer. All patients will receive MET-4 orally, starting with a loading dose followed by maintenance until week 4 of treatment or until side effects become too severe.

What are the potential side effects?

While not explicitly listed, potential side effects may include issues related to oral administration like nausea or trouble swallowing, reactions from gut bacteria changes due to MET-4, and typical chemotherapy and radiotherapy side effects like fatigue, skin irritation, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I am willing to provide mouth swab, stool, and blood samples when needed.

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I have been diagnosed with a specific type of throat cancer.

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I am eligible for treatment aimed at curing my cancer with both radiation and chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Relative abundance of MET-4 associated bacterial strains in stool samples collected at week 4, end of CRT and 2-month follow-up timepoints.

Toxicity defined by CTCAE v.5.0.

Secondary study objectives

Bacterial composition and diversity between baseline, week 4, end of CRT and 2 month follow-up samples

Bacterial composition and diversity of oral and stool samples in ROMA 1 (CRT alone) compared to ROMA 2 (CRT plus MET-4).

Other study objectives

Correlation between blood immune profiling and changes in oral/intestinal microbiome in the context of CRT and MET-4 administration.

Correlation between oral/intestinal microbiome and radiomics imaging analysis.

Stool and serum metabolomic profiles before/after CRT and MET-4.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: MET-4Experimental Treatment1 Intervention

Subjects diagnosed with Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (LA-OPSCC) will receive treatment with MET-4 in addition to standard of care CRT. MET-4 is administered orally as an initial daily loading dose over 2 days followed by a daily maintenance dose of MET-4 and will be administered until week 4 of CRT or unacceptable toxicity whichever occurs earlier and in the absence of criteria to discontinue MET-4.

0 / 3Eligibility criteria met