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

Germ Cell Tumor Clinical Trial

— HGT-QoL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889585
• Other study ID #: 2021-A00855-36
• Secondary ID: 2020/3139
• Status: Recruiting
• Start date: May 31, 2023
• Est. completion date: May 2024

Study information

• Verified date: June 2023
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Natacha NAOUN, MD
• Phone: + 33 (0)1 42 11 42 11
• Email: natacha.naoun[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Germ Cell Tumor
• Neoplasms, Germ Cell and Embryonal

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the quality of life between the three groups measured with the EORTC-QLQ C-30 questionnaire.	To compare the quality of life in long-term survivors of germ cell cancers after high-dose chemotherapy and autologous stem cell transplant with a group of coetaneous patients treated by orchidectomy only for localized testicular tumor and a group of patients of the same age treated with first line cisplatin-based chemotherapy for good or intermediate prognosis advanced germ cell tumor.	Day 1
Secondary	Compare late side effects between the three groups.		Day 1
Secondary	Compare correlated morbidities between the three groups.		Day 1
Secondary	Compare fatigue measured by the MFI-20 scale between the three groups.		Day 1
Secondary	Compare symptoms of post-traumatic stress measured by the IES scale between the three groups.		Day 1
Secondary	Compare current social and professional situation between the three groups.		Day 1