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Chemotherapy

mDCF + Avelumab for Esophago-gastric Adenocarcinoma

Phase 2

Waitlist Available

Led By Thierry Alcindor, MD, MSc

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

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 30±4 weeks

Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines avelumab with a modified chemotherapy regimen. The goal is to see if this new treatment can improve pathologic complete response rates and disease-free survival rates in patients with stomach, EGJ, or lower esophageal cancer.

Eligible Conditions

Esophageal Cancer
Stomach Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30±4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30±4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30±4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Pathologic Complete Response (pCR)

Secondary outcome measures

Safety Assessment of Adding Avelumab to mDCF

Two-Year Disease Free Survival (DFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: mDCF + AvelumabExperimental Treatment1 Intervention

Patients will receive neoadjuvant therapy consisting of 4 cycles of avelumab added to the modified chemotherapy regimen of docetaxel, cisplatin, 5-fluorouracil, followed by surgery and assessment of pathologic response. Then they will receive 4 cycles of adjuvant therapy of docetaxel, cisplatin, 5-fluorouracil and avelumab. Docetaxel as a one-hour 40 mg/m2 IV infusion on day 1. Cisplatin 40 mg/m2 IV infusion on day 1. 5-FU 1000 mg/m2/day over 2 days. Avelumab 10 mg/kg following the completion of the mDCF regimen.

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Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor

442 Previous Clinical Trials

159,119 Total Patients Enrolled

Thierry Alcindor, MD, MScPrincipal InvestigatorAssociate Director, Oncology Clinical Trials

1 Previous Clinical Trials

10 Total Patients Enrolled

Media Library

5-Fluorouracil (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03288350 — Phase 2

Esophageal Cancer Research Study Groups: mDCF + Avelumab

Esophageal Cancer Clinical Trial 2023: 5-Fluorouracil Highlights & Side Effects. Trial Name: NCT03288350 — Phase 2

5-Fluorouracil (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03288350 — Phase 2

Frequently Asked Questions

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

Does this experiment offer a unique approach to research?

"Since 2014, mDCF + Avelumab has been the focus of numerous clinical trials. The first study was sponsored by EMD Serono Research & Development Institute, Inc., and included 204 participants. After these initial results were promising enough to move forward with Phase 2 testing and approval, presently 112 live studies are being conducted in 1024 cities across 52 countries."

Answered by AI

What is the maximum capacity of participants for this research project?

"Affirmative. The info hosted on clinicaltrials.gov states that this research study, which was first publicized on February 22nd 2018, is actively looking for participants. Since then, it has been updated and now aims to enlist 55 individuals from a single site."

Answered by AI

Has the combination of mDCF and Avelumab been sanctioned by the Food & Drug Administration?

"We have assigned a 2 out of 3 to the safety profile for mDCF+Avelumab because it is only in phase two trials, thus there are data points suggesting its security but not yet any demonstrating efficacy."

Answered by AI

Could you tell me if this experiment is presently enrolling participants?

"According to the information on clinicaltrials.gov, enrollment for this medical trial is open; it was initially listed on February 22nd 2018 and has been recently updated on March 20th of that same year."

Answered by AI

What prior research has been conducted pertaining to the combination of mDCF and Avelumab?

"Presently, there are 112 studies in operation exploring mDCF + Avelumab. 10 of those trials have made it to Phase 3. The primary locations for research into this treatment is Barcelona and South dakota; however, globally, there are an additional 3685 sites conducting their own experiments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

mDCF + Avelumab in Resectable Esophago-gastric Adenocarcinoma (EGA)

Thierry Alcindor 2018. "mDCF + Avelumab in Resectable Esophago-gastric Adenocarcinoma (EGA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03288350.

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