Combination of radio- and chemotherapy for patients with stage IIA/B seminoma with reduced intesity.

Phase 1

• Conditions: stage IIA/B seminoma; MedDRA version: 21.0Level: PTClassification code 10043351Term: Testicular seminoma (pure) stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-000514-11-DE
• Lead Sponsor: Swiss Group for Clinical Cancer Research (SAKK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 170

Inclusion Criteria

- Histologically confirmed classical seminoma treated with primary inguinal orchidectomy or partial orchidectomy
- Patients with a seminoma stage IIA or B, either newly diagnosed or recurrent after primary active surveillance, adjuvant carboplatin or radiotherapy for stage I disease
- Stage IIA in patients with equivocal lymph node enlargement needs to be confirmed with a repeated CT/MRI scan
- Patients with a prior malignancy treated with curative intention are eligible if all treatment was completed at least 5 years before registration and the patient has no evidence of disease at registration
- WHO performance status 0-2
- Adequate bone marrow and renal function

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 167
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

- No other histological component than seminoma
- No elevated levels of AFP (= 2x ULN)
- No involved nodes (metastatic) in previously irradiated localizations in the abdomen or pelvis
- No anti-cancer therapy after primary tumor resection in patients presenting with primary stage IIA/B seminoma
- No serious underlying medical condition (i.e. current renal insufficiency, severe hepatic insufficiency, severe bone marrow dysfunction, tumor bleeding, major Hearing defects) or serious co-morbidity which could impair the ability of the patient to participate in the trial (according to investigator’s judgment)
- No concomitant drugs contraindicated for use with the trial drugs according to the approved product information or contraindicated for use with radiotherapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to investigate efficacy of a stage-adapted treatment regimen in stage IIA/B seminoma. ;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is:<br>Progression free survival (PFS) 3 years after registration<br>;Timepoint(s) of evaluation of this end point: 3 years after registration

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints of the trial are:<br>• Response rate (RR)<br>• PFS<br>• Time to progression (TTP)<br>• Overall survival (OS)<br>• Seminoma-specific survival<br>• Time to distant metastasis<br>• Time to next treatment<br>• Localization of progression<br>• Method of detection of progression<br>• Adverse events (AEs) temporarily associated with the trial treatment<br>• Late AEs<br>• Incidence of second tumors<br>• Development of metabolic syndrome<br>• Development of hypogonadism;Timepoint(s) of evaluation of this end point: at every study visit