Organ-Preserving Endoscopic Resection & Adjuvant RADIO-immuno-chemotherapy for Esophageal Cancer (NCT05667298) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Organ-Preserving Endoscopic Resection & Adjuvant RADIO-immuno-chemotherapy for Esophageal Cancer
Canada11 participantsStarted 2023-03-01
Plain-language summary
The goal of this study is to assess the safety of delivering concurrent adjuvant chemoradiation or immuno-radiation therapy after EMR/ESD in pT1b/T2N0 esophageal cancer patients. The main objectives of the study are:
1. Assess the feasibility of enrolling 10 patients.
2. Assess the safety of delivering concurrent adjuvant chemoradiation or immunoradiation therapy after EMR/ESD in pT1b/T2 esophageal cancer patients
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Haemoglobin ≥9.0 g/dL
✓. Absolute neutrophil count (ANC) ≥1.0 × 109 /L
✓. Platelet count ≥75 × 109/L
✓. Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). \<\<This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\>\>
✓. AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN
✓. Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
Exclusion criteria
✕. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
✕. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
✕. Patients with vitiligo or alopecia.
✕. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
✕. Any chronic skin condition that does not require systemic therapy.
What they're measuring
1
Feasibility of enrolling 10 patients
Timeframe: 1.5 years
2
Safety (proportion of patients developing Grade 3 or above adverse events)
✕. Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
✕. Patients with celiac disease controlled by diet alone.
✕. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of durvalumab and of low potential risk for recurrence