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 (HGT-QoL)

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.

Study Overview

• Status: Recruiting
• Conditions: Germ Cell Tumor
• Intervention / Treatment: Other: quality of life questionnaire

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natacha NAOUN, MD; Phone Number: 20 09 + 33 (0)1 42 11 42 11; Email: natacha.naoun@gustaveroussy.fr
• Study Contact Backup: Name: Karim Fizazi, MD, Prof.; Phone Number: + 33 (0)1 42 11 43 17; Email: karim.fizazi@gustaveroussy.fr

Study Locations

• France
  • Villejuif, France, 94805
    • Recruiting
    • Gustave Roussy
    • Contact: Natacha NAOUN, MD; Phone Number: 22 09 +33 (0)1 42 11 42 11; Email: natacha.naoun@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

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 orchidectomy 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.

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: quality of life questionnaire; EORTC-QLQ C-30 questionnaire The Impact of Events Scale (IES-R) Multi-Dimensional Fatigue Inventory The EORTC-QLQ C-30 Vers. 3
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: quality of life questionnaire; EORTC-QLQ C-30 questionnaire The Impact of Events Scale (IES-R) Multi-Dimensional Fatigue Inventory The EORTC-QLQ C-30 Vers. 3
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.	Other: quality of life questionnaire; EORTC-QLQ C-30 questionnaire The Impact of Events Scale (IES-R) Multi-Dimensional Fatigue Inventory The EORTC-QLQ C-30 Vers. 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal
• Other Study ID Numbers: 2021-A00855-36; 2020/3139 (Other Identifier: CSET Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No