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

Not Applicable

Recruiting

• Conditions: Germ Cell Tumor

• Registration Number: NCT05889585
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-30
• Study Start: 2023-05-31
• Study First Submitted QC: 2023-06-02
• Study First Posted: 2023-06-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare the quality of life between the three groups measured with the EORTC-QLQ C-30 questionnaire.	Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Compare correlated morbidities between the three groups.	Day 1
Compare symptoms of post-traumatic stress measured by the IES scale between the three groups.	Day 1
Compare late side effects between the three groups.	Day 1
Compare current social and professional situation between the three groups.	Day 1
Compare fatigue measured by the MFI-20 scale between the three groups.	Day 1

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, France