The RADIANCE multicenter, randomized phase II trial will assess the efficacy of durvalumab, a PD-L1 immune checkpoint inhibitor, in combination with primary mitomycin C (MMC)/5-fluorouracil (5-FU)-based radiochemotherapy (RCT) in patients with locally-advanced anal squamous cell carcinoma (ASCC).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically-confirmed ASCC (both genders) of the anal canal or the anal margin
* UICC-Stage IIB-IIIC including T2\>4cm Nany (IIB: T3N0M0; IIIA: T1-2N1M0; IIIB: T4N0M0; IIIC: T3-4N1M0; T2\>4cm Nany) according to proctoscopy, pelvic MRI, CT scan of thorax and abdomen, all within 30 days prior to recruitment
* Age ≥ 18 years, no upper age limit
* ECOG-Performance score 0-1
* History/physical examination within 30 days prior to recruitment
* Written informed consent and any locally-required authorization (e.g. EU Data Privacy Directive in the EU) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
* Life expectancy of \> 12 months
* Body weight \>30kg
* Hemoglobin ≥9.0 g/dl
* Leukocytes \>3.5 x 10 \^9/l
* Absolute neutrophil count (ANC) 1.5 x 10 9/l (\> 1500 per mm3)
* Platelet count ≥100 x 109/l (\>100,000 per mm3)
* 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), AP ≤ 3x institutional ULN
* Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula creatinine clearance
* Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the …