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Adjuvant Immunoradiotherapy (ARM1) and Adjuvant Immunotherapy (ARM1B) for Esophageal Cancer (OPERARADIO Trial)

Phase 1

Recruiting

Led By Biniam Kidane

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

OPERARADIO Trial Summary

This trial aims to determine if it is safe to provide additional chemotherapy and radiation therapy after a certain type of surgery in esophageal cancer patients. The main goals are to see if it is possible to

Who is the study for?

This trial is for adults over 18 with early-stage esophageal cancer (T1b/T2N0) who have completed a specific type of surgery (EMR/ESD), can't or won't get their esophagus removed, and meet certain health requirements like body weight and blood counts.Check my eligibility

What is being tested?

The study tests the safety of two additional treatments after surgery: one group gets chemo plus radiation (chemoradiation), while another gets immune therapy plus radiation. The goal is to enroll 10 patients to see if these approaches are safe.See study design

What are the potential side effects?

Potential side effects may include reactions related to chemotherapy, such as nausea, fatigue, hair loss; from radiotherapy like skin irritation, difficulty swallowing; and from immunotherapy which could cause flu-like symptoms or allergic reactions.

OPERARADIO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of enrolling 10 patients

Safety (proportion of patients developing Grade 3 or above adverse events)

Secondary outcome measures

Health-related quality of life (change in FACT-E score between pretreatment/baseline score to the score at the 2-year mark post-resection)

Progression-free survival

OPERARADIO Trial Design

2Treatment groups

Experimental Treatment

Group I: Adjuvant chemoradiotherapyExperimental Treatment1 Intervention

Some patients have medical conditions, i.e., severe auto-immune disease that prohibits them from receiving immunotherapy. In such patients, adjuvant therapy will be provided in the form of concurrent chemoradiotherapy (ARM2).

Group II: Adjuvant Immunoradiotherapy (ARM1) and Adjuvant Immunotherapy (ARM1B)Experimental Treatment1 Intervention

The primary/preferred adjuvant therapy will be immunoradiotherapy (ARM1); however, if this combination is felt to be too high-risk for specific patients, the next preferred therapy will be immunotherapy without radiation (ARM1B).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor

4,274 Previous Clinical Trials

288,613,411 Total Patients Enrolled

University of ManitobaLead Sponsor

595 Previous Clinical Trials

199,471 Total Patients Enrolled

Manitoba Medical Service FoundationOTHER

18 Previous Clinical Trials

1,056 Total Patients Enrolled

Frequently Asked Questions

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

Are there any vacancies available for patients to participate in this trial?

"As per data from clinicaltrials.gov, this investigation is currently seeking individuals to partake. The trial's initial posting was on the 3rd of January 2023 and its most recent update occurred on the 5th of April 2024."

Answered by AI

What is the current number of participants enrolled in this clinical research study?

"Indeed, the details on clinicaltrials.gov show that recruitment is ongoing for this trial. The trial was originally listed on March 1st, 2023 and was last revised on April 5th, 2024. Enrollment is sought for a total of 10 participants at a single site."

Answered by AI

What are the safety concerns associated with Adjuvant Immunoradiotherapy (ARM1) and Adjuvant Immunotherapy (ARM1B) in individuals undergoing treatment?

"Given that this is a Phase 1 trial with scant data supporting both safety and efficacy, Adjuvant Immunoradiotherapy (ARM1) and Adjuvant Immunotherapy (ARM1B) have been rated as 1 on the safety scale by our team at Power."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Organ-Preserving Endoscopic Resection & Adjuvant RADIO-immuno-chemotherapy for Esophageal Cancer

Biniam Kidane 2023. "Organ-Preserving Endoscopic Resection & Adjuvant RADIO-immuno-chemotherapy for Esophageal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05667298.

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