Validation of a treatment approach for poor-risk non-seminomatous germ cell tumors
A Prospective Program Aiming at Improving Outcome for Young Adults With Poor-prognosis
NA · Gustave Roussy, Cancer Campus, Grand Paris · NCT05705687
This study is testing a personalized treatment plan for young adults with hard-to-treat non-seminomatous germ cell tumors to see if it improves their outcomes based on how their tumor markers respond to chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 16 Years and up |
| Sex | Male |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Villejuif) |
| Trial ID | NCT05705687 on ClinicalTrials.gov |
What this trial studies
This prospective multicenter program aims to validate a personalized treatment algorithm for young adults with poor-prognosis non-seminomatous germ cell tumors (NSGCT). It includes a phase IV study for all patients, a phase II study specifically for those with primary mediastinal tumors and unfavorable tumor marker declines, and a diagnostic study excluding patients with brain metastases. The study focuses on assessing the efficacy and safety of treatment based on early tumor marker kinetics following chemotherapy. Participants will be monitored based on their tumor marker levels and the location of the primary tumor.
Who should consider this trial
Good fit: Ideal candidates include male patients over 16 years old with evidence of NSGCT and classified as having poor prognosis according to established criteria.
Not a fit: Patients with brain metastases or contraindications for brain MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for young adults with poor-prognosis NSGCT.
How similar studies have performed: Other studies have shown promise in using personalized treatment approaches for similar conditions, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male patient older than 16 years old on day of signing informed consent * Patient with evidence of NSGCT based on histologic examination or based on clinical evidence and elevated serum hCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are highly elevated) * Patient with testicular, retroperitoneal, or mediastinal primary site * Patient with evidence of disseminated disease (clinical stages II or III according to AJCC 8th edition) * Patient with disease classified as poor prognosis according to IGCCCG criteria: * Primary mediastinal NSGCT or, * Non-pulmonary visceral metastases or, * hCG \> 50 000 UI/L, or AFP \> 10 000 ng/mL, or LDH \> 10 times the upper normal value * Patient with adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance \> 60 mL/min. Cockcroft formula: CrCl = \[(140-age) x weight in kg\]/\[72 x serum creatinine (mg/dL)\] * Patient with absolute granulocyte count \> or = 1,500/mm\^3, platelets \> or = 100,000 mm\^3, bilirubin \< or = 1.5x the upper limit of normal value. * Patient with a contra-indication of undergoing any brain MRI are eligible, but will not be part of the diagnostic study part * Patient (and his legal guardian for under-18 patient) who had understood, signed and dated the informed consent form * Patient affiliated to social security system or beneficiary of the same * Male of child-bearing potential, must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake. Inclusion criteria specific to the phase 2 study in patients with unfavorable serum marker decrease and mediastinal primary tumor (to be confirmed before the end of the 1st BEP cycle) * Patient (and his legal guardian for under-18 patient) who had understood, signed and dated the specific Phase II informed consent form * Patient with mediastinal primary site * Patient with unfavorable serum marker decrease evaluated at D18-D21 of the first BEP-chemotherapy Exclusion Criteria: * Patient infected by the Human Immunodeficiency Virus (HIV) * Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent * Patient with prior chemotherapy. Patients who have received a first cycle of cisplatin-base chemotherapy (BEP) for their poor-prognosis NSGCT are eligible as far as tumor marker decline can be assessed at day 18-21. * Patient with previous malignancy, except for basal-cell carcinoma of the skin * Known allergy or hypersensitivity to any of the study drugs Non inclusion criteria specific to the phase 2 study in patients with unfavorable serum marker decrease and mediastinal primary tumor (to be confirmed before the end of the 1st BEP cycle) * Patient (and his legal guardian for under-18 patient) who withdraws his consent * Patient with Human T-cell Leukemia Virus (HTLV) type 1 and 2 * Patient with Hepatitis B surface antigen * Patient with Hepatitis C antibody * Patient with prior high-dose chemotherapy (HDCT) plus hematopoietic stem cell HSCs transplant
Where this trial is running
Villejuif
- Gustave Roussy — Villejuif, France (RECRUITING)
Study contacts
- Study coordinator: Elodie LECERF, MSc
- Email: elodie.lecerf@gustaveroussy.fr
- Phone: +33 (0)1 42 11 42 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-Seminomatous Germ Cell Tumor