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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

ConditionGerm Cell Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years at diagnosis

Treated between 1990 and 2015

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • quality of life questionnaire

    Other intervention

    EORTC-QLQ C-30 questionnaire The Impact of Events Scale (IES-R) Multi-Dimensional Fatigue Inventory The EORTC-QLQ C-30 Vers. 3

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: high-dose of chemotherapy with autologous transplant and relapse-free after a minimum of 3 years.Other 1 intervention
Group B: Treated by orchidectomy only and no evidence of relapse after a minimum of 3 yearsOther 1 intervention
Group C: Treated by first line cisplatin-based chemotherapy and relapse-free after a minimum of 3 years.Other 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1

Secondary outcomes

1

Compare late side effects between the three groups.

Time frame
Day 1
2

Compare correlated morbidities between the three groups.

Time frame
Day 1
3

Compare fatigue measured by the MFI-20 scale between the three groups.

Time frame
Day 1
4

Compare symptoms of post-traumatic stress measured by the IES scale between the three groups.

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gustave Roussy, Cancer Campus, Grand Paris

Lead sponsor

Source ClinicalTrials.gov
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