Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Adjuvant chemoradiotherapy · 1 trial · 1 indication
Assess the feasibility of enrolling 10 patients (i.e. Raw count of number of patients enrolled in 1.5 years)
Assess the safety of delivering concurrent adjuvant chemoradiation or immunoradiation therapy after EMR/ESD in pT1b/T2 esophageal cancer patients. This will be done using CTCAE. This will be descriptive and be based on proportion of patients developing Grade 3 or above adverse events.
| Arm | Type | Description |
|---|---|---|
| Adjuvant Immunoradiotherapy (ARM1) and Adjuvant Immunotherapy (ARM1B) | EXPERIMENTAL | The primary/preferred adjuvant therapy will be immunoradiotherapy (ARM1); however, if this combination is felt to be too high-risk for specific patients, the next preferred therapy will be immunotherapy without radiation (ARM1B). |
| Adjuvant chemoradiotherapy | EXPERIMENTAL | Some patients have medical conditions, i.e., severe auto-immune disease that prohibits them from receiving immunotherapy. In such patients, adjuvant therapy will be provided in the form of concurrent chemoradiotherapy (ARM2). |
| Name | Type | Description |
|---|---|---|
| Adjuvant Immunoradiotherapy (ARM1) and Adjuvant Immunotherapy (ARM1B) | DRUG | Durvalumab treatment is to begin six weeks following patient ESD/EMR surgery. Patients may delay dosing under the following certain circumstances: 1. Dosing may be delayed per Toxicity Management Guidelines (Appendix IV), due to either an immune or a non-immune-related AE. 2. Dosing intervals of subsequent cycles may be shortened as clinically feasible in order to gradually align treatment cycles with the schedule of tumor efficacy (RECIST) and PRO assessments. Subsequent time between 2 consecutive doses cannot be less than 22 days, based on the half-lives of durvalumab (see current Investigator Brochure for durvalumab). 3. Standard of Care Arm (CROSS): 4. Patients may delay and subsequently resume dosing per local standard clinical practice. If dosing must be delayed for reasons other than treatment-related toxicity, dosing will occur as soon as feasible. |
| Adjuvant chemoradiotherapy | DRUG | Durvalumab treatment is to begin six weeks following patient ESD/EMR surgery. Patients may delay dosing under the following certain circumstances: 1. Dosing may be delayed per Toxicity Management Guidelines (Appendix IV), due to either an immune or a non-immune-related AE. 2. Dosing intervals of subsequent cycles may be shortened as clinically feasible in order to gradually align treatment cycles with the schedule of tumor efficacy (RECIST) and PRO assessments. Subsequent time between 2 consecutive doses cannot be less than 22 days, based on the half-lives of durvalumab (see current Investigator Brochure for durvalumab). 3. Standard of Care Arm (CROSS): 4. Patients may delay and subsequently resume dosing per local standard clinical practice. If dosing must be delayed for reasons other than treatment-related toxicity, dosing will occur as soon as feasible. |
Inclusion Criteria: * AGE \>18 * Able to provide informed consent. * Pathological stage T1B or T2 esophageal or non-metastatic gastro-esophageal adenocarcinoma, squamous cell cancer or mixed histology. * Ineligible for or declining esophagectomy. * Completed endoscopic mucosal resection (EMR) or en...
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