Actively Recruiting
Prospective Therapeutic De-escalation and miRNA-M371 Biomarker Evaluation Phase II Study for Stage IIa/IIb Seminomas Less Than 3 cm
Led by Centre Leon Berard · Updated on 2024-01-25
90
Participants Needed
15
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying treatment options for patients with stage IIa or IIb seminoma smaller than 3 cm who have undergone orchiectomy. The trial evaluates a de-escalated chemotherapy approach followed by either a radiotherapy boost or carboplatin chemotherapy based on PET scan results. The study also investigates the biomarker miRNA-M371 to help guide treatment decisions and correlate with PET scan findings. Participants first receive one cycle of chemotherapy with etoposide and cisplatin (EP). Those with a negative PET scan at week 3 are randomly assigned to receive either a radiotherapy boost targeting lymph nodes or one cycle of carboplatin chemotherapy. Patients with a positive PET scan receive three additional cycles of EP chemotherapy. An observational group includes patients receiving standard radiotherapy without intervention. During the study, participants undergo imaging with PET scans and CT scans to monitor disease progression. Blood tests assess biomarker levels such as miRNA-M371, and quality of life and treatment tolerance are tracked over time. The primary outcome is progression-free survival up to 36 months after inclusion, with follow-up for up to five years to evaluate survival, biomarker association, and treatment effects. Participants are monitored closely throughout the study period, which extends up to several years for full outcome assessment.
CONDITIONS
Brief Title
De-escalation Study for Stage IIa/IIb < 3 cm Seminoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older on the day of signing informed consent
- Diagnosed with primary testicular seminomatous germ cell tumor
- Stage IIa or IIb seminoma smaller than 3 cm in largest diameter, confirmed after orchiectomy
- Confirmation of progressive disease by positive PET scan or increasing lymph node size on two CT scans
- Good prognosis according to IGCCCG and lactate dehydrogenase (LDH) less than 2.5 times the upper limit of normal
- Normal alpha-fetoprotein (AFP) levels before and after orchiectomy
- No prior chemotherapy or radiotherapy treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less
- Adequate bone marrow, liver, and kidney function as defined by specific blood test thresholds
- Willingness and ability to comply with study visits, treatments, and tests
- Agreeing to effective contraception or abstinence during the study and for 12 months after last chemotherapy dose, or surgically sterile
- Affiliated with a health insurance plan
- Signed and dated informed consent
You will not qualify if you...
- Presence of extra-retroperitoneal metastasis on CT scan
- Infection with HIV or active hepatitis B or C virus
- History of cancers other than seminoma within the last 2 years, except treated basal cell skin cancer
- Uncontrolled or severe heart disease
- Uncontrolled or severe liver disease
- Being deprived of liberty or requiring legal guardianship
- Psychological, physical, social, or geographic conditions limiting compliance with study requirements
- Participation in another clinical trial except for supportive care studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 9 weeks depending on treatment arm
Participants receive one cycle of EP chemotherapy followed by either a radiotherapy boost on lymph nodes or one cycle of carboplatin AUC7 based on PET scan results, or they receive 3 cycles of standard EP chemotherapy or standard radiotherapy depending on their assigned group.
1 to 3 treatment visits depending on assigned therapy
Duration - Up to 5 years
Participants are monitored for treatment efficacy and safety, including assessments of miRNA-M371 biomarker, PET scans, overall survival, quality of life, and treatment tolerance.
Periodic visits during follow-up for up to 5 years
Trial Site Locations
Total: 15 locations
1
CHU Besançon
Besançon, France
Not Yet Recruiting
2
CHU Bordeaux
Bordeaux, France
Actively Recruiting
3
Centre François Baclesse
Caen, France
Actively Recruiting
4
Centre Jean Perrin
Clermont-Ferrand, France
Actively Recruiting
5
Centre Oscar Lambret
Lille, France
Actively Recruiting
6
CHU de Limoges
Limoges, France
Actively Recruiting
7
Centre Leon Bérard
Lyon, France
Actively Recruiting
8
Institut Paoli Calmettes
Marseille, France
Actively Recruiting
9
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
10
Hôpital Saint Louis
Paris, France
Not Yet Recruiting
11
ICO René Gauducheau
Saint-Herblain, France
Actively Recruiting
12
Hôpital Foch
Suresnes, France
Not Yet Recruiting
13
Institut Universitaire de Cancer de Toulouse (IUCT-O)
Toulouse, France
Actively Recruiting
14
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Not Yet Recruiting
15
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
E
Ellen BLANC
A
Aude FLECHON, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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