Guided therapy for patients with seminoma using PET imaging

Therapeutic Strategy Guided by PET-TDM for Patients With Grade I or Metastatic Seminoma

This study is testing if using PET imaging to guide treatment can help patients with seminoma, both those with early-stage and advanced disease, respond better to medications like carboplatin and cisplatin.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 271 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Villejuif, Val de Marne)
• Trial ID: NCT01887340 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a therapeutic strategy guided by 18F-fluoro-deoxyglucose positron emission tomography (PET-TDM) for patients diagnosed with seminoma. It includes two cohorts: one for patients with grade I seminoma and another for those with metastatic seminoma. The study aims to determine how many patients can benefit from a tailored treatment approach based on PET imaging results. Interventions include the administration of carboplatin, etoposide, and cisplatin.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed seminoma who have not received prior chemotherapy or radiotherapy.

Not a fit: Patients with non-seminomatous germ cell tumors or those who have previously undergone treatment for seminoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for seminoma patients.

How similar studies have performed: Other studies utilizing PET imaging for treatment guidance in cancer have shown promising results, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria shared:

* Histologically proved seminoma after orchiectomy
* Primary testicular or retroperitoneal
* Normal alpha-fetoprotein before and after orchiectomy
* No prior treatment with radiotherapy or chemotherapy
* Age \>= 18 years
* ECOG 0 to 2
* PNN \>= 1500, platelets \>= 100 000, bilirubin \<= the upper limit nromale
* ASAT (SGOT) and ALAT (SGPT) \<= 1,5 x the upper limit nromale
* Serum creatinine \<140 µmol / L (or clearance\> 60 mL / min)
* Information and signed informed consent before inclusion in the study
* Patient affiliated to a social security

Specific inclusion criteria for cohort 1:

* grade I

Specific inclusion criteria for cohort 2:

* grade IIB (retroperitoneal adenopathy diameter between 2 cm and 5 cm, regardless of the LDH)
* grade IIC (retroperitoneal adenopathy diameter higher than 5 cm, regardless of the LDH)
* grade III of good prognosis (supradiaphragmatic reach with ganglionic metastasis and LDH \< 2 times normal limit and/or supradiaphragmatic reach with pulmonary metastasis and LDH \< 2 times normal limit) either at initial diagnosis or relapse of a grade I seminoma)
* PET-TDM positive (pathological fixation on metastatic lesions)

Exclusion Criteria shared:

* Patient infected by HIV, Hepatitis B or C
* History, within 5 years, of cancer other than seminoma, except for treated skin cancer (Basal Cell) .
* visceral metastasis
* cerebral metastasis
* Any physical or mental condition incompatible with the treatment (to the investigator discretion)
* Uncontrolled or severe cardiovascular pathology
* Uncontrolled or severe hepatic pathology
* Persons deprived of liberty or under guardianship
* Unable to undergo medical monitoring due to geographical, social or psychological reasons

Where this trial is running

Villejuif, Val de Marne

• Gustave Roussy — Villejuif, Val de Marne, France (Recruiting)

Study contacts

• Study coordinator: Yohann LORIOT, MD

Conditions Seminoma