Prospective Therapeutic De-escalation and miRNA-M371 Biomarker Evaluation Phase II Study for Stage IIa/IIb < 3 cm Seminomas

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years on the day of signing informed consent.

• Primary testicular seminomatous germ cell tumor.

• Stage IIa/IIb \< 3 cm in largest diameter seminoma, histologically proved after orchiectomy.

• Confirmation of a progressive disease (positive PET scan or increase of lymph nodes size by two successive CT scan).

• Good prognosis according to IGCCCG and LDH \< 2.5 x Upper Limit of Normal (ULN).

• Normal alpha-fetoprotein (AFP) before and after orchiectomy.

• No prior treatment with radiotherapy or chemotherapy.

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.

• 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.

⁃ Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

⁃ 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

⁃ Affiliation to a health insurance.

⁃ Signed and dated informed consent.

Locations
Other Locations
France
CHU Besançon
NOT_YET_RECRUITING
Besançon
CHU Bordeaux
RECRUITING
Bordeaux
Centre François Baclesse
RECRUITING
Caen
Centre Jean Perrin
RECRUITING
Clermont-ferrand
Centre Oscar Lambret
RECRUITING
Lille
CHU de Limoges
RECRUITING
Limoges
Centre Leon Bérard
RECRUITING
Lyon
Institut Paoli Calmettes
RECRUITING
Marseille
Centre Antoine Lacassagne
RECRUITING
Nice
Hôpital Saint Louis
NOT_YET_RECRUITING
Paris
ICO René Gauducheau
RECRUITING
Saint-herblain
Hôpital Foch
NOT_YET_RECRUITING
Suresnes
Institut Universitaire de Cancer de Toulouse (IUCT-O)
RECRUITING
Toulouse
Institut de Cancérologie de Lorraine
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Institut Gustave Roussy
RECRUITING
Villejuif
Contact Information
Primary
Ellen BLANC
ellen.blanc@lyon.unicancer.fr
+33 4 78 78 29 67
Backup
Aude FLECHON, Dr
aude.flechon@lyon.unicancer.fr
+ 33 4 78 78 26 43
Time Frame
Start Date: 2022-09-06
Estimated Completion Date: 2030-09-06
Participants
Target number of participants: 90
Treatments
Experimental: ARM A
RADIOTHERAPY boost 20 to 30 Gy on lymph nodes
Experimental: ARM B
One cycle of CARBOPLATIN AUC7
Other: ARM C
3 cycles of ETOPOSIDE and CISPLATIN
No_intervention: OBSERVATIONAL COHORT
STANDARD RADIOTHERAPY on lymph nodes
Related Therapeutic Areas
Sponsors
Leads: Centre Leon Berard

This content was sourced from clinicaltrials.gov