Radio-immuno-chemotherapy for Esophageal Cancer
(OPERARADIO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety of different treatments for early-stage esophageal cancer. Researchers are examining how well patients tolerate combined treatments that include chemotherapy, radiation, and immunotherapy. The trial targets individuals with early-stage esophageal cancer who have undergone a procedure to remove the tumor but are not candidates for major surgery. Those who have this type of cancer and have completed certain treatments without surgery might find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive potentially groundbreaking therapies.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have received anticancer therapy within 15 days before the trial or if you are on certain immunosuppressive medications. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that treatments like chemoradiotherapy and immunoradiotherapy are generally well-tolerated by patients. Studies indicate that chemoradiotherapy can be safe even with long-term use, though some patients do experience side effects, which are common in cancer treatments. Research has found immunoradiotherapy promising in terms of safety, with only a few patients experiencing severe side effects.
Regarding immunotherapy alone, research has shown it to be quite safe when used after surgery. In one study, most patients completed their treatment without major issues, and only a few had serious side effects.
Overall, these treatments have demonstrated manageable safety in previous studies. This suggests that while side effects can occur, they are usually not severe for most people.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for esophageal cancer because they combine traditional and cutting-edge therapies in new ways. Unlike standard treatments, which often involve chemoradiotherapy, these options explore the use of immunotherapy alongside radiation. Immunoradiotherapy, for instance, leverages the body's immune system to target cancer cells more effectively, potentially improving outcomes for patients who can handle this approach. For patients with severe autoimmune conditions, the trial offers chemoradiotherapy, providing a tailored option that avoids the risks of immunotherapy. These innovative combinations aim to enhance the effectiveness of treatment and provide safer alternatives for diverse patient needs.
What evidence suggests that this trial's treatments could be effective for esophageal cancer?
Research has shown that combining chemotherapy and radiation after surgery, known as adjuvant chemoradiotherapy, can extend the lives of people with esophageal cancer. In this trial, some participants will receive this combination as part of the adjuvant chemoradiotherapy arm. Studies suggest this approach often outperforms surgery alone, particularly in older patients.
Another group in this trial will receive adjuvant immunoradiotherapy, which combines immunotherapy with chemotherapy and radiation. This method can shrink tumors and may increase survival chances. Additionally, some participants may receive immunotherapy alone, as demonstrated in the CheckMate 577 trial, which showed improved cancer-free survival time after surgery. These treatments attack cancer cells and boost the body's immune system, potentially leading to longer and healthier lives for patients.36789Who Is on the Research Team?
Biniam Kidane
Principal Investigator
University of Manitoba
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Endoscopic Resection
Participants undergo endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) as a diagnostic and potentially curative procedure
Adjuvant Treatment
Participants receive adjuvant immunoradiation therapy or chemoradiation therapy based on eligibility
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Adjuvant Chemoradiotherapy
- Adjuvant Immunoradiotherapy
- Adjuvant Immunotherapy
- Adjuvant Radiotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Manitoba
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Manitoba Medical Service Foundation
Collaborator
CancerCare Manitoba
Collaborator