Adrenocortical carcinoma - null regimens

The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main adrenocortical carcinoma page for regimens that include active anticancer treatment.

Adjuvant therapy

Observation

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Terzolo et al. 2023 (ADIUVO)	2008-10-23 to 2018-12-27	Phase 3 (C)	Mitotane	Did not meet primary endpoint of RFS

Preceding treatment

• Adrenalectomy

No further treatment.

References

1. ADIUVO: Terzolo M, Fassnacht M, Perotti P, Libé R, Kastelan D, Lacroix A, Arlt W, Haak HR, Loli P, Decoudier B, Lasolle H, Quinkler M, Haissaguerre M, Chabre O, Caron P, Stigliano A, Giordano R, Zatelli MC, Bancos I, Fragoso MCBV, Canu L, Luconi M, Puglisi S, Basile V, Reimondo G, Kroiss M, Megerle F, Hahner S, Kimpel O, Dusek T, Nölting S, Bourdeau I, Chortis V, Ettaieb MH, Cosentini D, Grisanti S, Baudin E, Berchialla P, Bovis F, Sormani MP, Bruzzi P, Beuschlein F, Bertherat J, Berruti A. Adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma (ADIUVO): an international, multicentre, open-label, randomised, phase 3 trial and observational study. Lancet Diabetes Endocrinol. 2023 Oct;11(10):720-730. Epub 2023 Aug 21. link to original article link to PMC article PubMed NCT00777244

Recurrent, locally advanced, or metastatic disease

Placebo

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Fassnacht et al. 2015 (GALACCTIC)	2009-2011	Phase 3 (C)	Linsitinib	Did not meet primary endpoint of OS Median OS: 356 vs 323 days

No active antineoplastic treatment.

References

1. GALACCTIC: Fassnacht M, Berruti A, Baudin E, Demeure MJ, Gilbert J, Haak H, Kroiss M, Quinn DI, Hesseltine E, Ronchi CL, Terzolo M, Choueiri TK, Poondru S, Fleege T, Rorig R, Chen J, Stephens AW, Worden F, Hammer GD. Linsitinib (OSI-906) versus placebo for patients with locally advanced or metastatic adrenocortical carcinoma: a double-blind, randomised, phase 3 study. Lancet Oncol. 2015 Apr;16(4):426-35. Epub 2015 Mar 18. link to original article PubMed NCT00924989