Morbidity, Long-term Side Effects and Quality of Life in Germ-cell Tumor Long Survivors Treated with High-dose Chemotherapy and Autologous Stem Cell Transplant
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Intensified chemotherapy is an effective treatment in 30-70% of patients with refractory germ cell tumor. Since most cases are diagnosed before the age of 40, survivors can expect to live another 30 to 50 years after being successfully treated. Long-term side effects and physical and emotional consequences can therefore have a significant impact on daily life. To date, no data of this type is available in France. This study will help clinicians better understand the long-term consequences for relapsed patients receiving high-dose chemotherapy.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years at diagnosis
• Treated between 1990 and 2015
• Histologically confirmed diagnosis of germ cell tumor (or high level serum tumor marker-based) and:
⁃ Treated for relapse with high-dose of chemotherapy (HDCT) with autologous transplant at Gustave Roussy and relapse-free.
⁃ Or Treated by orchiectomy only and no evidence of relapse after a minimum of 3 years.
⁃ Or Good or intermediate prognosis metastatic disease according to the IGCCCG, treated by first line cisplatin-based chemotherapy at Gustave Roussy (and surgery of residual masses if needed), with no evidence of relapse.
• Ability to comply with the protocol procedures
• Patient affiliated to a social security system or beneficiary of the same. 6-Who have signed a written informed consent form prior to any study specific procedure.
Locations
Other Locations
France
Gustave Roussy
RECRUITING
Villejuif
Contact Information
Primary
Natacha NAOUN, MD
natacha.naoun@gustaveroussy.fr
+ 33 (0)1 42 11 42 11
Backup
Karim Fizazi, MD, Prof.
karim.fizazi@gustaveroussy.fr
+ 33 (0)1 42 11 43 17
Time Frame
Start Date:2023-05-31
Estimated Completion Date:2025-05
Participants
Target number of participants:180
Treatments
Other: high-dose of chemotherapy with autologous transplant and relapse-free after a minimum of 3 years.
Men with a histologically-confirmed (or high level serum tumor marker-based) diagnosis of germ-cell tumor, treated for relapse with high-dose of chemotherapy (HDCT) with autologous transplant at Gustave Roussy and relapse-free after a minimum of 3 years.
Other: Treated by orchidectomy only and no evidence of relapse after a minimum of 3 years
Men with a histologically confirmed (or high level serum tumor marker-based) stage I germ cell tumor, treated by orchidectomy only and no evidence of relapse after a minimum of 3 years.
Other: Treated by first line cisplatin-based chemotherapy and relapse-free after a minimum of 3 years.
Men with a histologically confirmed (or high level serum tumor marker-based) germ cell tumor and good or intermediate prognosis metastatic disease according to the International Germ-Cell Cancer Collaborative Group (IGCCCG), treated by first line cisplatin-based chemotherapy (and surgery of residual masses if needed), with no evidence of relapse after a minimum of 3 years.