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Radio-immuno-chemotherapy for Esophageal Cancer (OPERARADIO Trial)

Phase 1

Waitlist Available

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

No Placebo-Only Group

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of enrolling 10 patients

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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