Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06144736
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-11-10
Brief Title:
PRIMETEST II - Clinical Stage II AB Seminoma Treated With RA-RPLND
Sponsor:
Heinrich-Heine University Duesseldorf
Organization:
Heinrich-Heine University Duesseldorf
Study Overview
Official Title:
PRIMETEST II - Phase II Trial to Prospectively Test New Predictors for Recurrence in Patients With Clinical Stage II AB Seminoma Treated With RA-RPLND
Status:
RECRUITING
Status Verified Date:
2023-11
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:
PRIMETEST II is an interventional study involving low-volume metastatic seminoma It explores a novel approach using robot-assisted primary retroperitoneal lymph node dissection aiming to reduce long-term side effects and improve quality of life By identifying factors predicting cancer recurrence the study hopes to tailor treatments for better outcomes The approach could potentially spare patients from chemotherapy induced long-term side effects while maintaining excellent survival rates presenting a promising shift in testicular cancer care for this specific patient group
Detailed Description:
Testicular cancer stands as the most prevalent cancer among young men boasting a highly favorable prognosis characterized by almost unaltered long-term survival even in advanced stages However traditional treatments like chemotherapy and radiation are linked to significant long-term toxicity and increased rates of secondary malignancies Particularly late toxicities mainly cardiovascular substantially diminish overall survival by approximately 6-7 years To circumvent unnecessary acute and long-term toxicities associated with radiation or chemotherapy its crucial to explore alternative therapeutic avenues through personalized less toxic approaches
Building upon the hypothesis-generating PRIMETEST I study PRIMETEST II is a single-arm non-randomized prospective study It aims to explore novel and personalized predictive parameters for recurrence following a robot-assisted primary retroperitoneal lymph node dissection pRA-RPLND in patients with clinical stage IIAB seminoma involving low-volume metastatic disease up to 5 cm These patients represent a rare subgroup among testicular cancer patients making a randomized comparison of treatment options impractical due to their low prevalence The overarching goal is to reduce long-term toxicity in this young cohort of cancer patients and enhance their quality of life through personalized clinical and molecular predictions
PRIMETEST I has indicated that pRA-RPLND in patients with clinical stage IIAB seminoma led to a 70 recurrence-free survival at 32 months follow-up These findings suggest that pRA-RPLND could serve as an alternative to standard therapies chemotherapy radiotherapy for a highly selective group of patients effectively preventing excessive toxicity PRIMETEST I has already identified several potential factors that predict which patients are more likely to benefit from surgical therapy alone
In the novel prospective setting of PRIMETEST II the study tests the identified predictive factors for recurrence Patients exhibiting presumably low-risk features about 70 of patients will continue with surgery alone Those with a presumed higher risk of recurrence will undergo robot-assisted surgery and have the option of receiving adjuvant treatment one cycle of cisplatin etoposide and bleomycin The primary endpoint is a three-year recurrence-free survival estimated to exceed 90 Additional objectives include exploring new predictors of recurrence at both molecular and clinical levels by analyzing serum and tissue samples from the primary tumor and metastases
This innovative approach anticipates that 70 of patients will avoid long-term toxicity and experience excellent recurrence-free survival rates comparable to standard chemotherapy or radiation therapy
Building upon the hypothesis-generating PRIMETEST I study PRIMETEST II is a single-arm non-randomized prospective study It aims to explore novel and personalized predictive parameters for recurrence following a robot-assisted primary retroperitoneal lymph node dissection pRA-RPLND in patients with clinical stage IIAB seminoma involving low-volume metastatic disease up to 5 cm These patients represent a rare subgroup among testicular cancer patients making a randomized comparison of treatment options impractical due to their low prevalence The overarching goal is to reduce long-term toxicity in this young cohort of cancer patients and enhance their quality of life through personalized clinical and molecular predictions
PRIMETEST I has indicated that pRA-RPLND in patients with clinical stage IIAB seminoma led to a 70 recurrence-free survival at 32 months follow-up These findings suggest that pRA-RPLND could serve as an alternative to standard therapies chemotherapy radiotherapy for a highly selective group of patients effectively preventing excessive toxicity PRIMETEST I has already identified several potential factors that predict which patients are more likely to benefit from surgical therapy alone
In the novel prospective setting of PRIMETEST II the study tests the identified predictive factors for recurrence Patients exhibiting presumably low-risk features about 70 of patients will continue with surgery alone Those with a presumed higher risk of recurrence will undergo robot-assisted surgery and have the option of receiving adjuvant treatment one cycle of cisplatin etoposide and bleomycin The primary endpoint is a three-year recurrence-free survival estimated to exceed 90 Additional objectives include exploring new predictors of recurrence at both molecular and clinical levels by analyzing serum and tissue samples from the primary tumor and metastases
This innovative approach anticipates that 70 of patients will avoid long-term toxicity and experience excellent recurrence-free survival rates comparable to standard chemotherapy or radiation therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None