Therapy De-escalation in Seminoma Stage IIA/B

Phase 2 Terminated 120 enrolled Swiss Cancer Institute

NaSingle-groupOpen-labelTreatment

Summary

The main objective of this trial is to test the efficacy and safety of carboplatin chemotherapy and involved node radiotherapy in patients with stage IIA/B seminoma.

Timeline

Start: 2012-06-15
Primary completion: 2025-01-30
Completion: 2025-01-30

Outcome

Missed primary endpoint

Stopped (Business): “Board decided to prematurely terminate the follow-up phase of the trial due to funding reasons”

paper With a target progression-free survival of 95% at 3 years, the primary endpoint was not met. PMID 36228644 ↗

Publications

Papachristofilou A, Bedke J, Hayoz S, Schratzenstaller U, Pless M, Hentrich M, Krege S, Lorch A, Aebersold DM, Putora PM, Berthold DR, Zihler D, Zengerling F, Dieing A, Mueller AC, Schaer C, Biaggi C, Gillessen S, Cathomas R. Single-dose carboplatin followed by involved-node radiotherapy for stage IIA and stage IIB seminoma (SAKK 01/10): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022 Nov;23(11):1441-1450. doi: 10.1016/S1470-2045(22)00564-2. Epub 2022 Oct 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	—	Other