Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma

Phase 2 Completed 53 enrolled Centre Oscar Lambret French Sarcoma Group · collab Study Group of Bone Tumors · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomization discontinuation trial will allow for concomitant evaluation of the following: * Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle * Side effects and benefits of a drug holiday

Timeline

Start: 2011-02
Primary completion: 2018-05-16
Completion: 2018-08-09

Outcome

Met primary endpoint

paper After randomisation, progression-free survival at 6 months was 51·9% (95% CI 31·9-68·6) in the continuation group versus 23·1% (9·4-40·3) in the interruption group (p=0·0200). PMID 25680558 ↗

Publications

Le Cesne A, Blay JY, Domont J, Tresch-Bruneel E, Chevreau C, Bertucci F, Delcambre C, Saada-Bouzid E, Piperno-Neumann S, Bay JO, Mir O, Ray-Coquard I, Ryckewaert T, Valentin T, Isambert N, Italiano A, Clisant S, Penel N. Interruption versus continuation of trabectedin in patients with soft-tissue sarcoma (T-DIS): a randomised phase 2 trial. Lancet Oncol. 2015 Mar;16(3):312-9. doi: 10.1016/S1470-2045(15)70031-8. Epub 2015 Feb 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trabectedin	Small molecule	1.5 mg/m2	Intravenous