Study Results
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Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2022-09-06
2030-09-06
Brief Summary
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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.
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Detailed Description
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The optimal treatment choice remains controversial. Both treatment modalities are associated with excellent efficacy but also acute and late toxicities. European Society of Medical Oncology (ESMO) guidelines recommended in equal measure CT and RT for stage IIa. A recent systematic review concluded that RT and cisplatin-based combination CT are equally effective in clinical stage IIa/IIb seminoma, with a trend in favor of chemotherapy in stage IIb because of lower relapse rate. However, due to the rarity of stage II seminoma, a sufficiently powered randomized trial comparing radiotherapy with chemotherapy is unlikely to be completed.
De-escalation strategies are required to minimize acute and long-term toxicities while maintaining efficacy. De-escalated treatment for seminoma patients with stage IIb/IIC/III and good prognosis according to International Germ Cell Cancer Collaborative Group (IGCCCG), based on negative PET after 2 cycles of EP chemotherapy, is feasible and safe according to SEMITEP results (cohort 2). In case of negative PET, 1 additional cycle of CT with carboplatin AUC7 was administered.
Furthermore, serum levels of microRNA (miR)-371a-3p (miRNA-M371) have been significantly associated with clinical stage, primary tumor size and response to treatment in testicular germ cell tumors, with sensitivity and specificity higher than those of classic markers (hCGt, LDH). However, further evaluations are needed before modifying clinical practices.
We propose to conduct a multicenter, prospective, randomized, non-comparative, de-escalation phase II study in patients with stage IIa/IIb seminoma \< 3 cm, evaluating:
* a more de-escalated CT treatment: 1 cycle of EP followed, in case of negative PET, by either a boost of RT on lymph node or 1 cycle of carboplatin AUC7
* the biomarker miRNA-M371 in therapeutic decision and correlation with PET.
In parallel, eligible patients scheduled to receive standard lombo-aortic RT will be registered in an observational cohort.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Boost of radiotherapy 20 to 30 Gray (Gy) (ARM A)
2. Carboplatin AUC7 chemotherapy (ARM B)
* In case of positive week-3 PET-scan: 3 courses of EP chemotherapy (ARM C)
Parallel observational cohort for patients scheduled to receive standard lumbo-aortic radiotherapy after orchiectomy
TREATMENT
NONE
Study Groups
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ARM A
RADIOTHERAPY boost 20 to 30 Gy on lymph nodes
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
ARM B
One cycle of CARBOPLATIN AUC7
Carboplatin AUC7
Carboplatin at dose (mg) = AUC7 (mg/ml x min) x (DFG ml/min + 25)
ARM C
3 cycles of ETOPOSIDE and CISPLATIN
3 cycles of EP
3 Cycles of EP chemotherapy, administred every 3 weeks following standard practice
OBSERVATIONAL COHORT
STANDARD RADIOTHERAPY on lymph nodes
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
MALE
No
Sponsors
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Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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Aude FLECHON, Dr
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard (Lyon, France)
Locations
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CHU Besançon
Besançon, , France
CHU Bordeaux
Bordeaux, , France
Centre François Baclesse
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Oscar Lambret
Lille, , France
CHU de Limoges
Limoges, , France
Centre Leon Bérard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Centre Antoine Lacassagne
Nice, , France
Hôpital Saint Louis
Paris, , France
ICO René Gauducheau
Saint-Herblain, , France
Hôpital Foch
Suresnes, , France
Institut Universitaire de Cancer de Toulouse (IUCT-O)
Toulouse, , France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EDEN (ET21-344)
Identifier Type: -
Identifier Source: org_study_id
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