Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
NCT ID:
NCT03490292
Eligibility Criteria:
Inclusion Criteria:
1. Patients with histologically confirmed, potentially curable squamous-cell carcinoma, adenocarcinoma, or large-cell undifferentiated carcinoma of the esophagus and gastroesophagus (Siewert type 1-3)
2. Locoregional disease with clinical stage of T1N1 or T2-3N0-2
3. No clinical evidence of metastatic spread. Staging should include endoscopic ultrasound and positron emission tomography/computed tomography (PET/CT) as recommended by National Comprehensive Cancer Network (NCCN) guidelines. PET/CT should be performed within 3 weeks of signing informed consent
4. Age 18 years or older
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
6. Subjects must be deemed to be potential surgical candidates by an evaluating surgeon
7. Adequate organ function:
1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
2. Hemoglobin ≥ 9 g/dL (transfusions allowed)
3. Platelets ≥ 100 x 109/L
4. Aspartate transaminase/Alanine transaminase (AST/ALT) ≤ 2.5 x ULN
5. Total serum bilirubin of ≤1.5 x institutional upper limit of normal (ULN)
6. Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula
8. Female patients of childbearing potential must have a negative pregnancy test (urine or serum) within 21 days prior to the start of the study drug treatment and must agree to use adequate birth control if conception is possible during the study and up to 30 days after the completion of adjuvant therapy
9. Male patients must agree to use adequate birth control during the study and up to 30 days after the last avelumab dose
10. Women who are nursing must discontinue breast-feeding prior to the enrollment in the trial
11. Patient must be able and willing to comply with study procedures as per protocol
12. Patient able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures
Exclusion Criteria:
1. Prior history of radiation to the mediastinum
2. Diagnosis of cervical esophageal carcinoma
3. Other active malignancy within the last 3 years (except for non-melanoma skin cancer, a non-invasive/in situ cancer, or indolent non metastatic Gleason 6 prostate cancer)
4. Subjects with an active or known autoimmune disease. Subjects with type I diabetes mellitus, hypo- or hyperthyroidism only requiring hormone replacement/suppression, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic immunosuppressive treatment are eligible
5. Current use of immunosuppressive medication, except for the following:
1. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
2. systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent
3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
6. Active infection requiring systemic therapy at the time of study treatment initiation
7. Prior organ transplantation including allogenic stem-cell transplantation
8. Known history of testing positive for HIV or known immunodeficiency syndrome
9. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
10. Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines
11. Major surgery within prior 4 weeks of treatment initiation (the surgical incision should be fully healed prior to all neoadjuvant treatment initiation)
12. Any prior anticancer therapy for esophageal cancer
13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel or avelumab, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3)
14. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. Patients with stable rate-controlled atrial fibrillation will be allowed to participate
15. Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
16. Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03490292
Study Brief:
Protocol Section:
NCT03490292