RADIANCE Radiochemotherapy +/- Durvalumab for locally-advanced Anal Carcinoma; A multicenter, randomized, phase II trial of the German Anal Cancer Study Group

Conditions

Anal cancer stage II and III, locally-advanced Anal Carcinoma

Brief summary

disease free survival

Detailed description

Acute and late toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Treatment compliance and safety, Complete clinical response rate assessed 26 weeks after initiation of RCT (defined by re-staging MRI and proctoscopy, including biopsies of suspicious findings), Overall survival (OS, defined as the time between randomization and death from any cause), Colostomy-free survival, Cumulative incidence of locoregional and distant recurrences, Quality of Life according to EORTC QLQ–C30 (version 3.0) and functional outcome per EORTC ANL27, Value of various MRI sequences, including diffusion-weighted MRI, for prediction and monitoring of treatment response, Translational / biomarker studies

Related papers

No related papers found yet.

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
disease free survival	—

Secondary

Measure	Time frame
Acute and late toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Treatment compliance and safety, Complete clinical response rate assessed 26 weeks after initiation of RCT (defined by re-staging MRI and proctoscopy, including biopsies of suspicious findings), Overall survival (OS, defined as the time between randomization and death from any cause), Colostomy-free survival, Cumulative incidence of locoregional and distant recurrences, Quality of Life according to EORTC QLQ–C30 (version 3.0) and functional outcome per EORTC ANL27, Value of various MRI sequences, including diffusion-weighted MRI, for prediction and monitoring of treatment response, Translational / biomarker studies	—

Measure

Time frame

Acute and late toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Treatment compliance and safety, Complete clinical response rate assessed 26 weeks after initiation of RCT (defined by re-staging MRI and proctoscopy, including biopsies of suspicious findings), Overall survival (OS, defined as the time between randomization and death from any cause), Colostomy-free survival, Cumulative incidence of locoregional and distant recurrences, Quality of Life according to EORTC QLQ–C30 (version 3.0) and functional outcome per EORTC ANL27, Value of various MRI sequences, including diffusion-weighted MRI, for prediction and monitoring of treatment response, Translational / biomarker studies

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Countries

Austria, Germany

Outcome results

None listed