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 (NCT02341989, EUDRACT 2014-004075-23)
One course of adjuvant carboplatin AUC7 is considered internationally to be a standard treatment option in clinical stage I seminoma, regardless of risk factors. Treatment is based on a large, randomized phase III study comparing adjuvant carboplatin with adjuvant radiotherapy. This study was done without registering data on possible risk factor for relapse. The relapse rate following carboplatin was in this study estimated to be 5.3 %. Data from a prospective, risk-adapted Spanish study showed that patients without risk factors had a very low risk of relapse, even without adjuvant treatment. This result is also confirmed by a recent analysis of SWENOTECA VII data, showing that this group of patients has a risk of relapse of less than 5 % without adjuvant treatment. The same data estimated a relapse-rate in patients with one or two risk factors followed by surveillance of about 20 %. Combined data from SWENOTECA V and VII indicate a relapse rate reduction of 65 % with one course of adjuvant carboplatin with a relapse rate of 9.4 % compared to 22 % without adjuvant treatment in patients with one or two risk factors (tumor > 4 cm, stromal invasion of rete testis) .
Based on these results the current SWENOTECA guidelines in SWENOTECA IX recommend adjuvant treatment with 1 course of Carboplatin AUC 7 for patients with one or two risk factors and surveillance for patients lacking risk factors .
However, due to the fairly modest effect of Carboplatin SWENOTECA wants to explore the possibility of a more efficient treatment strategy in patients with seminoma CSI with risk factors. One course of BEP has shown to be very potent in the adjuvant setting in non-seminoma CSI, reducing the relapse rate with 90-95 %. SWENOTECA is therefore launching the ABC trial, a randomized trial for seminoma CSI, comparing 1 course of Carboplatin with 1 course of BEP in an adjuvant setting. With an expected low relapse rate, possibly close to 1%, SWENOTECA believes that the higher acute toxicity of 1 BEP is outweighed by its greater efficacy compared to 1 cycle of Carboplatin. The ABC trial opens for inclusion on April 9, 2015 and is aiming at including 348 patients during a 54 month period with all major centers in Norway and Sweden participating.
Inclusion, randomisation, crf-reporting, and study documents are found and reported within a WEBCRF.
Remember to let the patients fill out all planned questionaires. They can all be found in the WEBCRF.
The study opened for inclution April 7. 2015.
Following randomisation patient identification and patient study number should be reported to the study office (Norway only): Telephone: +47 72 82 61 60/ 72 82 10 06. In case of no reply a mail should be sent to the study office and study personel will contact the local investigator as soon as possible.
Questions regarding the study, requests for webcrf access and SAE reports can be directed to the study office: email@example.com
Questionaires should be sent to the study office by mail after the patient have completed them:
Kunnskapssenteret 4. etg
St. Olavs Hospital
Postboks 3250 Sluppen
7006 Trondheim, Norge
Sponsor: The Cancer Clinic, St. Olavs University Hospital, Trondheim, Norway
Primary Investigator: Torgrim Tandstad, St. Olavs University Hospital, Trondheim, Norway
National Investigator, Sweden, Olof Ståhl, Skane University Hospital, Lund, Sweden