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De-escalation Study for Stage IIa/IIb < 3 cm Seminoma

NCT05529251 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-01-25

No results posted yet for this 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.

Conditions

  • Seminoma
  • Stage II

Interventions

RADIATION

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

DRUG

Carboplatin AUC7

Carboplatin at dose (mg) = AUC7 (mg/ml x min) x (DFG ml/min + 25)

DRUG

3 cycles of EP

3 Cycles of EP chemotherapy, administred every 3 weeks following standard practice

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Aude FLECHON, Dr · Centre Leon Berard (Lyon, France)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2025-09-06
Completion
2030-09-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05529251 on ClinicalTrials.gov