Informations générales (source: ClinicalTrials.gov)
Prospective Therapeutic De-escalation and miRNA-M371 Biomarker Evaluation Phase II Study for Stage IIa/IIb < 3 cm Seminomas (EDEN)
Interventional
Phase 2
Centre Leon Berard (Voir sur ClinicalTrials)
septembre 2022
septembre 2030
29 juin 2024
Phase II, multicenter, prospective, randomized, non-comparative, de-escalation study.
Patients with stage IIa/IIb < 3 cm seminoma histologically proved after orchiectomy will
be included in the study and will receive 1 cycle of Etoposide Cisplatine (EP)
chemotherapy.
Patients with negative week-3 PET-scan after the EP cycle, will be randomized (1:1 ratio,
stratification according to the disease stage (stage IIa versus IIb seminoma)) to receive
either radiotherapy (RT) boost on lymph nodes or 1 cycle of carboplatin AUC7
chemotherapy.
Patients with positive week-3 PET-scan will received 3 additional cycles of EP
chemotherapy.
In parallel, eligible patients scheduled to receive standard lombo-aortic RT will be
registered in an observational cohort.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Pierre BLANCHARD | 09/04/2024 12:14:24 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| HOPITAL FOCH | Christine ABRAHAM | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - Nice - France | Agnès DUCOULOMBIER | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - Caen - France | Florence JOLY | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - Clermont-Ferrand - France | Hakim MAHAMMEDI | Contact (sur clinicalTrials) | |||
| Centre Leon Bérard - Lyon - France | Aude FLECHON | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - Lille - France | Thomas RYCKEWAERT | Contact (sur clinicalTrials) | |||
| CHU Besançon - Besançon - France | Elodie KLAJER | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - Bordeaux - France | Marine GROSS-GOUPIL | Contact (sur clinicalTrials) | |||
| CHU de Limoges - Limoges - France | Julia PESTRE MUNIER | Contact (sur clinicalTrials) | |||
| Hôpital Saint Louis - Paris - France | Stéphane CULINE | Contact (sur clinicalTrials) | |||
| ICO René Gauducheau - Saint-Herblain - France | Emmanuelle BOMPAS | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - Vandœuvre-lès-Nancy - France | Lionel GEOFFROIS | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - Marseille - France | Gwenaëlle GRAVIS | Contact (sur clinicalTrials) | |||
| Institut Universitaire de Cancer de Toulouse (IUCT-O) - Toulouse - France | Christine CHEVREAU | Contact (sur clinicalTrials) | |||
Critères
Homme
Inclusion criteria :
1. Age ≥ 18 years on the day of signing informed consent.
2. Primary testicular seminomatous germ cell tumor.
3. Stage IIa/IIb < 3 cm in largest diameter seminoma, histologically proved after
orchiectomy.
4. Confirmation of a progressive disease (positive PET scan or increase of lymph nodes
size by two successive CT scan).
5. Good prognosis according to IGCCCG and LDH < 2.5 x Upper Limit of Normal (ULN).
6. Normal alpha-fetoprotein (AFP) before and after orchiectomy.
7. No prior treatment with radiotherapy or chemotherapy.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
9. Adequate bone-marrow, hepatic, and renal functions with:
- Neutrophils ≥ 1.5 x Giga/l, platelets ≥ 100 x Giga/l,
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 1,5 x
ULN,
- Serum creatinine < 140 µmol/l OR calculated clearance > 60 ml/min (using either
Cockcroft-Gault formula or Modification of Diet in Renal Disease (MDRD) for >
65 years old),
- Direct and total bilirubin ≤ ULN.
10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures.
11. Accepting to use effective contraceptive measures or abstain from heterosexual
activity, for the course of the study and through 12 months after the last dose of
chemotherapy or being surgically sterile. All patients should seek advice regarding
cryoconservation of sperm prior treatment initiation because of the possibility of
infertility
12. Affiliation to a health insurance.
13. Signed and dated informed consent.
Non-exclusion criteria :
1. Extra-retroperitoneal metastasis on Computed tomography scan (CT scan).
2. Infection by Human Immunodeficiency Virus (HIV), or active infection with the
Hepatitis B or C virus.
3. History, within 2 years, of cancer other than seminoma, except for treated skin
cancer (basal cell).
4. Uncontrolled or severe cardiovascular pathology.
5. Uncontrolled or severe hepatic pathology.
6. Patient deprived of liberty or requiring tutorship or curatorship.
7. Psychological, physical, sociological, or geographical conditions that would limit
compliance with study protocol requirements (at the investigator's discretion).
8. Participation to another clinical trial, except for supportive care trials.
1. Age ≥ 18 years on the day of signing informed consent.
2. Primary testicular seminomatous germ cell tumor.
3. Stage IIa/IIb < 3 cm in largest diameter seminoma, histologically proved after
orchiectomy.
4. Confirmation of a progressive disease (positive PET scan or increase of lymph nodes
size by two successive CT scan).
5. Good prognosis according to IGCCCG and LDH < 2.5 x Upper Limit of Normal (ULN).
6. Normal alpha-fetoprotein (AFP) before and after orchiectomy.
7. No prior treatment with radiotherapy or chemotherapy.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
9. Adequate bone-marrow, hepatic, and renal functions with:
- Neutrophils ≥ 1.5 x Giga/l, platelets ≥ 100 x Giga/l,
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 1,5 x
ULN,
- Serum creatinine < 140 µmol/l OR calculated clearance > 60 ml/min (using either
Cockcroft-Gault formula or Modification of Diet in Renal Disease (MDRD) for >
65 years old),
- Direct and total bilirubin ≤ ULN.
10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures.
11. Accepting to use effective contraceptive measures or abstain from heterosexual
activity, for the course of the study and through 12 months after the last dose of
chemotherapy or being surgically sterile. All patients should seek advice regarding
cryoconservation of sperm prior treatment initiation because of the possibility of
infertility
12. Affiliation to a health insurance.
13. Signed and dated informed consent.
Non-exclusion criteria :
1. Extra-retroperitoneal metastasis on Computed tomography scan (CT scan).
2. Infection by Human Immunodeficiency Virus (HIV), or active infection with the
Hepatitis B or C virus.
3. History, within 2 years, of cancer other than seminoma, except for treated skin
cancer (basal cell).
4. Uncontrolled or severe cardiovascular pathology.
5. Uncontrolled or severe hepatic pathology.
6. Patient deprived of liberty or requiring tutorship or curatorship.
7. Psychological, physical, sociological, or geographical conditions that would limit
compliance with study protocol requirements (at the investigator's discretion).
8. Participation to another clinical trial, except for supportive care trials.