Actively Recruiting
De-escalation Study for Stage IIa/IIb < 3 cm Seminoma
Led by Centre Leon Berard · Updated on 2024-01-25
90
Participants Needed
15
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
De-escalation Study for Stage IIa/IIb < 3 cm Seminoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 years or older
- Histologically confirmed primary testicular seminomatous germ cell tumor
- Stage IIa or IIb seminoma with tumor less than 3 cm in largest diameter after orchiectomy
- Progressive disease confirmed by positive PET scan or increased lymph node size on two CT scans
- Good prognosis per IGCCCG and LDH less than 2.5 times upper limit of normal
- Normal alpha-fetoprotein levels before and after orchiectomy
- No prior chemotherapy or radiotherapy treatments
- ECOG performance status of 2 or less
- Adequate bone marrow, liver, and kidney function with specified lab values
- Ability and willingness to comply with study visits and procedures
- Use of effective contraception or abstinence during study and for 12 months after last chemotherapy dose
- Affiliation to a health insurance plan
- Signed informed consent form
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 other cancers within 2 years except treated basal cell skin cancer
- Uncontrolled or severe heart or liver disease
- Legal incapacity or requiring guardianship
- Conditions limiting compliance with study protocol as judged by investigator
- Participation in another clinical trial except supportive care trials
AI-Screening
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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
CONTACT
A
Aude FLECHON, Dr
CONTACT
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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