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

All Individual Drugs Already Approved

No Placebo-Only Group

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

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

Primary study objectives

Pathologic Complete Response (pCR)

Secondary study objectives

Safety Assessment of Adding Avelumab to mDCF

Two-Year Disease Free Survival (DFS)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: 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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