Sequelae of Treatment in Survivors of Testicular Cancer Creation of a Non-exposed Comparison Group for the Platinum Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Proportion of patients with ototoxicity
Study Overview
Brief Summary
The patients enrolled on this new study will serve as an appropriate comparison group consisting of patients with the diagnosis of germ cell testicular cancer who were cured with surgical resection and did not receive cisplatin-based chemotherapy with a group of patients from another study who did receive cisplatin-based chemotherapy.
Detailed Description
Primary Objective
To compare the prevalence of ototoxicity and neurotoxicity in GCT cancer survivors who only had surgery to a similar population from The Platinum Study (RSRB45410/1305011509) who received cisplatin-based combination chemotherapy.
Secondary Objective
To compare the prevalence of obesity, hypertension, and use of antidepressants/anxiolytics in GCT cancer survivors who only had surgery to a similar population from The Platinum Study who received cisplatin-based combination chemotherapy.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis or confirmation of diagnosis of a histologically or serologically confirmed testicular germ cell tumor (GCT) or GCT at another anatomic location
- •Age at GCT diagnosis: 55 years of age or younger
- •Males, 18 years of age or older at time of study consent
- •Subject is able to provide consent
- •Subject is able to speak and read English
- •Treatment consisted of surgery only (i.e., orchiectomy and/or retroperitoneal lymph node dissection [RPLND]) for either initial testicular germ cell tumor (GCT) or subsequent testicular cancer
- •Subject completed surgery > 1 year ago
- •Subject is currently undergoing active follow-up at IU
- •Subject did not require any subsequent chemotherapy, salvage chemotherapy treatment or bone marrow transplant.
- •Subject had no prior chemotherapy of any kind
Exclusion Criteria
- •Patients with prior chemotherapy (whether for GCT or any other cancer)
Outcomes
Primary Outcomes
Proportion of patients with ototoxicity
Time Frame: 1 year after surgery
The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.
Proportion of patients with neurotoxicity
Time Frame: 1 year after surgery
The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.
Secondary Outcomes
- Proportion of patients with obesity(1 year after surgery)
- Proportion of patients with hypertension(1 year after surgery)
- Proportion of patients who use antidepressants/anxiolytics(1 year after surgery)
Investigators
Lawrence Einhorn
Distinguished Professor of Medicine
Indiana University School of Medicine