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Trial Title:
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
NCT ID:
NCT05889585
Condition:
Germ Cell Tumor
Conditions: Official terms:
Neoplasms, Germ Cell and Embryonal
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
quality of life questionnaire
Description:
EORTC-QLQ C-30 questionnaire The Impact of Events Scale (IES-R) Multi-Dimensional Fatigue
Inventory The EORTC-QLQ C-30 Vers. 3
Arm group label:
Treated by first line cisplatin-based chemotherapy and relapse-free after a minimum of 3 years.
Arm group label:
Treated by orchidectomy only and no evidence of relapse after a minimum of 3 years
Arm group label:
high-dose of chemotherapy with autologous transplant and relapse-free after a minimum of 3 years.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Diagnosis of second malignancy
- Any other serious or unstable illness, or medical, social, or psychological
condition, that could jeopardize the safety of the subject and/or his compliance
with study procedures, or may interfere with the subject's participation in the
study or evaluation of the study results.
- Patient under guardianship or deprived of his/her liberty by a judicial or
administrative decision, or incapable of giving his/her consent.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Last name:
Natacha NAOUN, MD
Phone:
+33 (0)1 42 11 42 11
Phone ext:
22 09
Email:
natacha.naoun@gustaveroussy.fr
Start date:
May 31, 2023
Completion date:
May 2025
Lead sponsor:
Agency:
Gustave Roussy, Cancer Campus, Grand Paris
Agency class:
Other
Source:
Gustave Roussy, Cancer Campus, Grand Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05889585
