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| ID | Type | Description | Link |
|---|---|---|---|
| 2020/3139 | Other Identifier | CSET Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high-dose of chemotherapy with autologous transplant and relapse-free after a minimum of 3 years. | Other | 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. |
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| Treated by orchidectomy only and no evidence of relapse after a minimum of 3 years | Other | 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. |
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| Treated by first line cisplatin-based chemotherapy and relapse-free after a minimum of 3 years. | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quality of life questionnaire | Other | EORTC-QLQ C-30 questionnaire The Impact of Events Scale (IES-R) Multi-Dimensional Fatigue Inventory The EORTC-QLQ C-30 Vers. 3 |
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| 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 |
| Measure | Description | 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. |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natacha NAOUN, MD | Contact | + 33 (0)1 42 11 42 11 | 20 09 | natacha.naoun@gustaveroussy.fr |
| Karim Fizazi, MD, Prof. | Contact | + 33 (0)1 42 11 43 17 | karim.fizazi@gustaveroussy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy | Recruiting | Villejuif | 94805 | France |
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| 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 |
| ID | Term |
|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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