The Platinum Study Comparison Group
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/11/2018 |
| Start Date: | May 2015 |
| End Date: | December 2018 |
Sequelae of Treatment in Survivors of Testicular Cancer Creation of a Non-exposed Comparison Group for the Platinum Study
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.
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.
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.
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.
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)
We found this trial at
1
site
535 Barnhill Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(888) 600-4822
Principal Investigator: Lawrence Einhorn, MD
Phone: 317-278-4923
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
Click here to add this to my saved trials
