Adjuvant Bleomycin, Etoposide and Cisplatin (BEP) Versus Carboplatin in Stage I Seminomatous Testicular Cancer
Information source: St. Olavs Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Testicular Neoplasms; Seminoma
Intervention: Bleomycin Etoposide and Cisplatin (Drug); Carboplatin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: St. Olavs Hospital Official(s) and/or principal investigator(s): Olof Ståhl, Md PhD, Principal Investigator, Affiliation: Skåne University Hospital Torgrim Tandstad, MD PhD, Principal Investigator, Affiliation: St Olavs University Hospital
Overall contact: Torgrim Tandstad, MD PhD, Phone: +47 72826166, Email: torgrim.tandstad@stolav.no
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Relapse rate
Detailed description:
Short term overall survival is, regardless of treatment allocation, expected to be very
close to 100 %. The primary outcome is relapse rate. The power of the study depends on the
number of observed relapses. If the relapse rate in the adjuvant carboplatin group, the
reference group, is lower than the anticipated 9 %, we need to include more patients to the
study. Based on all previous published material on adjuvant treatment in clinical stage I
seminoma it is not possible to precisely estimate the correct relapse rate until the median
follow-up is four years. Consequently, we will estimate the relapse rate in the reference
group close to the end of accrual. If the estimated relapse rate, and thus the number of
relapses, is lower than the anticipated we will increase the sample size to make sure that
the study meets the minimum required number of relapses in the reference group. A possible
inclusion of more study participants does not compromise the Type I error rate of the study.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Histological diagnosis of unilateral seminoma testicular cancer, evaluating both size
of tumor and invasion of the rete testis
- Clinical stage I
- Tumor size over 4 cm and/or stromal invasion of the rete testis by tumor cells
- Normal value of alpha-fetoprotein (AFP) before orchiectomy. A stable, slightly
elevated AFP as a normal value may be permitted.
- Age ≥ 18 years and < 60 years
- Adequate organ function defined as:
Serum aspartate transaminase (ALT) ≤ 1. 5 x upper limit of normal (ULN). Total serum
bilirubin ≤ 1. 5 x ULN Absolute neutrophil count (ANC) ≥ 1. 5 x 109/L Platelets ≥ 100 x
109/L Creatinine clearance > 50 ml/min (eGFR) All fertile patients should use safe
contraception Written informed consent
Exclusion Criteria:
- Signs of metastatic disease evaluated by CT thorax, abdomen and pelvis. Patients in
need of restaging (see SWENOTECA IX) should not be included
- Prior diagnosis of testicular cancer
- Chronic pulmonary disorders giving a high risk of bleomycin induced toxicity (for
example chronic obstructive pulmonary disease or lung fibrosis)
- Cancer other than seminoma testicular cancer
- Known hypersensitivity or contraindications for the study drugs
- Serious concomitant systemic disorders (for example active infection, unstable
cardiovascular disease) that in the opinion of the investigator would compromise the
patient's ability to complete the study or interfere with the evaluation of the
efficacy and safety of the study treatment
- Medical, social, psychological conditions that could prevent adequate information and
follow-up
Locations and Contacts
Torgrim Tandstad, MD PhD, Phone: +47 72826166, Email: torgrim.tandstad@stolav.no
Institutt for kreftforskning og molekylær medisin, St Olavs Hospital, Trondheim, Norway; Recruiting Torgrim Tandstad, md phd, Email: torgrim.tandstad@ntnu.no
Additional Information
Starting date: April 2015
Last updated: April 7, 2015
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