Clinical trial NCT05889585: 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
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Germ Cell Tumor
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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.

Primary outcomes:
measure: Compare the quality of life between the three groups measured with the EORTC-QLQ C-30 questionnaire.
timeFrame: Day 1
Secondary outcomes:
measure: Compare late side effects between the three groups.
timeFrame: Day 1
measure: Compare correlated morbidities between the three groups.
timeFrame: Day 1
measure: Compare fatigue measured by the MFI-20 scale between the three groups.
timeFrame: Day 1
measure: Compare symptoms of post-traumatic stress measured by the IES scale between the three groups.
timeFrame: Day 1
measure: Compare current social and professional situation between the three groups.
timeFrame: Day 1
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
References: