Adjuvant Bleomycin, Etoposide and Cisplatin (BEP) Versus Carboplatin in Stage I Seminomatous Testicular Cancer (SWENOTECA-ABC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02341989|
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : November 5, 2018
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.
Combined data from SWENOTECA V and VII studies indicate a high risk of relapse in patients with one or two risk factors (tumor 4 cm, stromal invasion of rete testis) treated with one course of adjuvant carboplatin. The relapse rate in this group of patients was 9.4 %, indicating a very modest effect of one course of adjuvant carboplatin. If adjuvant chemotherapy is the preferred treatment strategy, more potent chemotherapy regimens should be explored in this patient group. The results from SWENOTECA III/VI studies with one course of cisplatin-based adjuvant chemotherapy in clinical stage I nonseminoma, show a very low rate of relapse. As seminoma is even more chemosensitive than nonseminoma the relapse rate following one course of adjuvant BEP is expected to be very low, close to 1 %.
The overall aim is to investigate whether one course of adjuvant BEP have a lower relapse rate than one course of adjuvant carboplatin AUC7. In addition, it will be investigated if there is a difference in health related quality of life as well as acute and long-term toxicities from treatment.
|Condition or disease||Intervention/treatment||Phase|
|Testicular Neoplasms Seminoma||Drug: Bleomycin Etoposide and Cisplatin Drug: Carboplatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||348 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 8, 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
One course of adjuvant BEP.
Drug: Bleomycin Etoposide and Cisplatin
Other Name: BEP
Active Comparator: Carboplatin
One course of adjuvant carboplatin AUC7
Other Name: Carboplatin AUC7
- Relapse rate [ Time Frame: 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341989
|Contact: Torgrim Tandstad, MD PhD||+47 firstname.lastname@example.org|
|Institutt for kreftforskning og molekylær medisin, St Olavs Hospital||Recruiting|
|Contact: Torgrim Tandstad, md phd email@example.com|
|Principal Investigator:||Olof Ståhl, Md PhD||Skane University Hospital|
|Principal Investigator:||Torgrim Tandstad, MD PhD||St Olavs University Hospital|