The Platinum Study Comparison Group

Testicular Neoplasms Clinical Trial

Official title:

Sequelae of Treatment in Survivors of Testicular Cancer Creation of a Non-exposed Comparison Group for the Platinum Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890030
• Other study ID #: IRB No. 1604502652
• Status: Completed
• Start date: May 2015
• Est. completion date: June 14, 2017

Study information

• Verified date: April 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 14, 2017
• Est. primary completion date: June 14, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Testicular Neoplasms

Intervention

Behavioral:
• Questionnaire
Neurotoxicity Medications of interest General health Family history

Locations

Country	Name	City	State
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Lawrence Einhorn

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with ototoxicity	The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.	1 year after surgery
Primary	Proportion of patients with neurotoxicity	The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.	1 year after surgery
Secondary	Proportion of patients with obesity	The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.	1 year after surgery
Secondary	Proportion of patients with hypertension	The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.	1 year after surgery
Secondary	Proportion of patients who use antidepressants/anxiolytics	The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study.	1 year after surgery