Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003800
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Diagnostic Study of Patients With Stage I Testicular Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Correlation of Histopathology Immunohistochemistry and Quantitative Radiology With Outcome in Early Stage Nonseminomatous Germ Cell Tumor
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Diagnostic procedures may improve a doctors ability to predict the recurrence of testicular cancer
PURPOSE Diagnostic trial to detect the risk of recurrent disease in patients who have stage I testicular cancer and who have undergone orchiectomy within the previous 12 weeks
PURPOSE Diagnostic trial to detect the risk of recurrent disease in patients who have stage I testicular cancer and who have undergone orchiectomy within the previous 12 weeks
Detailed Description:
OBJECTIVES
Use histopathological and immunohistological analysis of the primary testis tumor along with quantitative radiographic assessment to identify a subset of patients with clinical stage I nonseminomatous germ cell tumor of the testis who have a very low risk of metastasis
Compare these findings with other predictive models of risk of metastasis after orchiectomy in this group of patients
OUTLINE Patients undergo primary retroperitoneal lymph node dissection RPLND or active surveillance as management of their disease The choice of treatment is determined by the physician and the patient Patients with pathologically positive resected lymph nodes may undergo treatment observation or adjuvant chemotherapy at investigators discretion
All patients are tested by quantitative radiology and blood markers HCG and AFP at baseline and then at various times after surgery to identify pathologic stage II disease The timing of these studies depends on the stage of disease andor type of disease management
Patients who undergo RPLND have stage I or II disease and do not receive adjuvant therapy radiation or chemotherapy are followed monthly during year 1 every 2 months during year 2 every 6 months during years 3-5 and annually thereafter
Patients who undergo RPLND have stage II disease and receive adjuvant therapy are followed every 2 months during year 1 every 4 months during year 2 every 6 months during years 3-5 and annually thereafter
Patients who do not undergo RPLND are followed monthly during year 1 every other month during year 2 every 6 months during years 3-5 and annually thereafter
PROJECTED ACCRUAL A total of 315 patients will be accrued for this study within 3 years
Use histopathological and immunohistological analysis of the primary testis tumor along with quantitative radiographic assessment to identify a subset of patients with clinical stage I nonseminomatous germ cell tumor of the testis who have a very low risk of metastasis
Compare these findings with other predictive models of risk of metastasis after orchiectomy in this group of patients
OUTLINE Patients undergo primary retroperitoneal lymph node dissection RPLND or active surveillance as management of their disease The choice of treatment is determined by the physician and the patient Patients with pathologically positive resected lymph nodes may undergo treatment observation or adjuvant chemotherapy at investigators discretion
All patients are tested by quantitative radiology and blood markers HCG and AFP at baseline and then at various times after surgery to identify pathologic stage II disease The timing of these studies depends on the stage of disease andor type of disease management
Patients who undergo RPLND have stage I or II disease and do not receive adjuvant therapy radiation or chemotherapy are followed monthly during year 1 every 2 months during year 2 every 6 months during years 3-5 and annually thereafter
Patients who undergo RPLND have stage II disease and receive adjuvant therapy are followed every 2 months during year 1 every 4 months during year 2 every 6 months during years 3-5 and annually thereafter
Patients who do not undergo RPLND are followed monthly during year 1 every other month during year 2 every 6 months during years 3-5 and annually thereafter
PROJECTED ACCRUAL A total of 315 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-8897 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |