mDCF + Avelumab in Resectable Esophago-gastric Adenocarcinoma (EGA)
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|ClinicalTrials.gov Identifier: NCT03288350|
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : March 22, 2018
This is a single-center, single-arm, open-label, Simon 2-stage, phase II trial in up to 55 patients with a potentially resectable, histologically-proven, adenocarcinoma or poorly differentiated carcinoma of the stomach, esophagogastric junction (EGJ), or lower third of the esophagus.
Patients will receive neoadjuvant therapy consisting of 4 cycles of avelumab added to the modified chemotherapy regimen of docetaxel, cisplatin, 5- fluorouracil. Following surgery, pathologic response will be assessed. Patients will then receive adjuvant therapy consisting of 4 cycles of mDCF + avelumab. Patients will be followed to assess two-year disease-free survival rates.
The primary objective of this study is to assess the effect on pathologic complete response rate (pCR) of adding avelumab to an mDCF regimen. The secondary objectives of this study are to determine the safety of adding avelumab to an mDCF regimen and assess its effect on two-year disease-free survival.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma Esophageal Adenocarcinoma||Drug: mDCF + Avelumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Perioperative PD-L1 Inhibition With Avelumab and Docetaxel, Cisplatin and 5-Fluorouracil for Resectable Locally Advanced Esophago-Gastric Adenocarcinoma|
|Actual Study Start Date :||February 22, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2023|
Experimental: mDCF + Avelumab
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.
Drug: mDCF + Avelumab
Patients will receive neoadjuvant therapy consisting of 4 cycles of avelumab added to the modified chemotherapy regimen of docetaxel, cisplatin, 5-fluorouracil (mDCF), followed by surgery and assessment of pathologic response. Then they will receive 4 cycles of adjuvant therapy of mDCF and avelumab.
- Pathologic Complete Response (pCR) [ Time Frame: 30±4 weeks ]Assessment of the pathologic complete response (pCR) rate after preoperative (neoadjuvant) treatment. pCR has been shown to correlate with long-term outcomes.For the purpose of this study, pCR is considered to represent grade 0 and grade 1 responses, defined by the criteria of the College of American Pathologists.
- Two-Year Disease Free Survival (DFS) [ Time Frame: 104 weeks ]Analysis of two-year disease-free survival (DFS) following treatment.
- Safety Assessment of Adding Avelumab to mDCF [ Time Frame: 104 weeks ]Measurement of the incidence of grade 3 or 4 avelumab-related adverse events following treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288350
|Contact: Touhid Opu, MBBS, MSc||514-934-1934 ext firstname.lastname@example.org|
|McGill University Health Centre||Recruiting|
|Montréal, Quebec, Canada, H4A 3J1|
|Contact: Penny Chipman 514-934-1934 ext 64802 email@example.com|
|Principal Investigator: Thierry Alcindor, MD, MSc|
|Principal Investigator:||Thierry Alcindor, MD, MSc||Associate Director, Oncology Clinical Trials|