Radiotherapy boost: Radiotherapy boost 20 to 30 Gy, in daily 2 Gy fractions and 5 fractions per week :
* 20 Gy if no more disease is visible (node \< 1 cm in large diameter)
* 24 Gy for nodes \<= 2 cm
* 30 Gy for nodes \> 2 cm
Carboplatin AUC7: Carboplatin at dose (mg) = AUC7 (mg/ml x min) x (DFG ml/min + 25)
3 cycles of EP: 3 Cycles of EP chemotherapy, administred every 3 weeks following standard practice
Study 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
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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),
* Total bilirubin ≤ ULN (if \> ULN, direct 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.
Primary outcome measure(s)
PFR-36M — Up to 36 months after inclusion Progression-free rate at 36 months
The PFR-36M is assumed to be a random variable following a binomial distribution Bin (n, p) where n is the sample size and p is the true underlying PFR-36M. Conclusions and inferences will be conducted on p. The prior distribution of p (representing the knowledge of the progression-free rate probability prior to observing the data) will be pre-specified. In the absence of a strong idea about the PFR-36M to be observed, a non-informative prior distribution Beta (1,1) will be considered.
Pr\[PFR-36M ≥ 80%\] will be expressed in each arm, associated with its 95% credibility interval. A treatment arm will be considered a positive sign for efficacy of de-escalation if there is a high probability that PFR-36M will be higher or equal to 80%: Pr\[PFR-36M ≥ 80%\] ≥ 90%. It means that if most of the distribution (90% of it) falls to the right hand side of 80%, it indicates that it is very likely that the effect is at least 80%
Trial sites (15)
Facility
City
Region
Status
CHU Besançon
Besançon
France
Recruiting
CHU Bordeaux
Bordeaux
France
Recruiting
Centre François Baclesse
Caen
France
Recruiting
Centre Jean Perrin
Clermont-Ferrand
France
Recruiting
Centre Oscar Lambret
Lille
France
Recruiting
CHU de Limoges
Limoges
France
Recruiting
Centre Leon Bérard
Lyon
France
Recruiting
Institut Paoli Calmettes
Marseille
France
Recruiting
Centre Antoine Lacassagne
Nice
France
Active Not Recruiting
Hôpital Saint Louis
Paris
France
Not Yet Recruiting
ICO René Gauducheau
Saint-Herblain
France
Recruiting
Hôpital Foch
Suresnes
France
Not Yet Recruiting
Institut Universitaire de Cancer de Toulouse (IUCT-O)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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