The ABC-study: A randomized phase III study comparing one course of adjuvant bleomycin, etoposide, and cisplatin (BEP) and one course of carboplatin AUC7 in clinical stage I seminomatous testicular cancer.

Authors

null

Torgrim Tandstad

St. Olav's University Hospital, Trondheim, Norway

Torgrim Tandstad , Olof Stahl , Olav Dahl , Ingrid Glimelius , Hege Sagstuen Haugnes , Asa Karlsdottir , Carl Wilhelm Langberg , Karin Soderstrom , Arne Solberg , Ulrika K. Stierner , Najme Wall , Gabriella Elisabeth Cohn-Cedermark

Organizations

St. Olav's University Hospital, Trondheim, Norway, Lund University Hospital, Lund, Sweden, Institute of Medicine, Fana, Norway, Department of Oncology, Uppsala University Hospital, Uppsala, Sweden, University Hospital of North Norway, Tromso, Norway, Department of Oncology, Haukeland University Hospital, Bergen, Norway, Oslo University Hospital, Oslo, Norway, Umeå University Hospital, Umeå, Sweden, Department of Oncology, Sahlgrenska University Hospital, Göteborg, Sweden, Department of Oncology, Linköping University Hospital, Linköping, Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden

Research Funding

Other

Background: Clinical stage I seminomatous testicular cancer is by far the most frequent presentation of testicular cancer. Treatment options include surveillance or adjuvant treatment, internationally one course of adjuvant carboplatin (AUC7) is the preferred adjuvant treatment. Tumor size and stromal invasion in the rete testis can be used to identify patients with a higher risk of relapse. Recent data have showed only a modest effect of adjuvant carboplatin in preventing relapse, and more potent adjuvant therapies should be explored to this group of patients. Methods: The ABC-study is a investigator initiated randomized, open, phase III study comparing standard adjuvant chemotherapy in the form of one course carboplatin AUC7 to one course of BEP (Bleomycin, etoposide and cisplatin), in patients with one or two risk factors. Based on SWENOTECA data from one course of adjuvant carboplatin AUC7 we estimate the relapse rate in patients with one or two risk factors to be 9 %. We consider a reduction in relapse free survival of 7 % to be the minimum difference that will lead to routine use of one course of adjuvant BEP. To demonstrate an improvement in relapse rate from 9 to 2 % with an α = 0.05 and β = 0.80, 332 evaluable patients are required. We expect a dropout rate of maximum 5 %, and therefore intend to randomize a total of 348 patients. Enrollment in the study started in 2015, and as of February 1. 2017 a total of 66 patients have been enrolled. Accrual have been slower than expected, but the current accrual rate is about 6-7 patients a month. We invite institutions and collaboratory groups to participate in this study. NCT02341989. EUDRACT 2014-004075-23. Clinical trial information: NCT02341989

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary (Nonprostate) Cancer

Track

Genitourinary Cancer—Kidney and Bladder

Sub Track

Germ Cell/Testicular

Clinical Trial Registration Number

NCT02341989

Citation

J Clin Oncol 35, 2017 (suppl; abstr TPS4593)

DOI

10.1200/JCO.2017.35.15_suppl.TPS4593

Abstract #

TPS4593

Poster Bd #

269b

Abstract Disclosures

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