Reduced Intensity Radio-chemotherapy for Stage IIA/B Seminoma

• Register: ClinicalTrials.gov
• Last refreshed on: 3 July 2023
• Main ID: NCT03937843
• Date of registration: 29/04/2019
• Prospective Registration: Yes
• Primary sponsor: Swiss Group for Clinical Cancer Research
• Public title: Reduced Intensity Radio-chemotherapy for Stage IIA/B Seminoma
• Scientific title: Reduced Intensity Radio-chemotherapy for Stage IIA/B Seminoma. A Multicenter, Open Label Phase II Trial With Two Cohorts
• Date of first enrolment: July 29, 2019
• Target sample size: 135
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03937843
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Germany, Switzerland

Contacts

• Name: Alexandros Papachristofilou, MD
• Affiliation: Universitätsspital Basel

Key inclusion & exclusion criteria

Inclusion Criteria:

- Written informed consent according to ICH/GCP (International Council on
Harmonization/Good Clinical Practice) regulations before registration and prior to any
trial specific procedures

- Histologically confirmed classical seminoma treated with primary inguinal orchidectomy
or partial orchidectomy

- Patients with a seminoma stage IIA or IIB, either newly diagnosed or recurrent after
primary active surveillance, adjuvant carboplatin or radiotherapy for stage I disease.
The tumor stage is pT1-4 cN1-2 cM0 according to UICC TNM 8th edition 2016. Patients
with a recurrent seminoma stage IIA or IIB are only eligible in case of progression
under active surveillance or recurrence after 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 of the abdomen (suggested timeframe: 4 weeks after the
previous scan) in order to rule out false positive lymph node enlargement.

Patients with a prior malignancy treated with curative intention are eligible if all
treatment of that malignancy was completed at least 5 years before registration and the
patient has no evidence of disease at registration. Less than 5 years is acceptable for
malignancies with low risk of recurrence and/or no late recurrence. Patients with a germ
cell neoplasia in situ (GCNIS) or contralateral localized treated seminoma are eligible

- Diagnostic CT or MRI or FDG-PET-CT of the chest, abdomen and pelvis within 28 days
prior to registration, showing stage IIA/B disease. I.v. contrast medium has to be
administered

- Age = 18 years

- WHO performance status 0-2

- Baseline PRO questionnaires have been completed

- Adequate bone marrow function: neutrophil count = 1.0 x 109/L, platelet count = 100x
109/L

- Adequate renal function: creatinine clearance = 60 ml/min calculated according to the
CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula

- Patient agrees to use highly effective contraception and not to donate sperm or to
father a child during trial treatment and during 12 months thereafter. Patient has
been proposed sperm conservation.

Exclusion criteria

- Any other histological component than seminoma

- Elevated levels of Alpha-1-Fetoprotein AFP (= 2x ULN)

- Involved nodes (metastatic) in previously irradiated localizations in the abdomen or
pelvis

- Any anti-cancer therapy after primary tumor resection in patients presenting with
primary stage IIA/B seminoma

- Any 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)

- Any treatment in a clinical trial within 28 days prior to registration

- Any concomitant drugs contraindicated for use with the trial drugs according to the
approved product information or contraindicated for use with radiotherapy

- Known hypersensitivity to trial drugs or to any component of the trial drugs

- Any other serious underlying medical, psychiatric, psychological, familial or
geographical condition, which in the judgment of the investigator may interfere with
the planned staging, treatment and follow-up, affect patient compliance or place the
patient at high risk from treatment-related complications.

Additional German specific exclusion criteria - not to be considered for Swiss patients

- Patient who is dependent on the sponsor or the investigators according to ICH/GCP
E6(R2), guideline

- Patient who has been committed to an institution by virtue of an order issued either
by the judicial or the administrative authorities according to § 40a (2) AMG.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Seminoma

Testicular Cancer

Intervention(s)

Drug: Etoposide

Drug: Cisplatin

Drug: Carboplatin

Primary Outcome(s)

Progression free survival (PFS) at 3 years [Time Frame: From the date of registration until the date of progressive disease, relapse or death, whichever occurs first, assessed up to 3 years after registration]

Secondary Outcome(s)

Localization of progression [Time Frame: at the date of the first occurrence of progressive disease, assessed from registration up to 20 years after registration]

Progression free survival (PFS) [Time Frame: From the date of registration until the date of progressive disease, relapse or death, whichever occurs first, assessed up to 20 years after registration]

Response rate (RR) [Time Frame: at 3 months and 3 years after registration]

Method of detection of progression [Time Frame: at the date of the first occurrence of progressive disease, assessed from registration up to 20 years after registration]

Overall Survival (OS) [Time Frame: From the date of registration until the date of death from any cause, assessed up to 20 years after registration]

Time to distant metastasis [Time Frame: From the date of registration until the date of first occurrence of distant metastasis, assessed up to 20 years after registration]

Time to next treatment [Time Frame: From the date of registration until the date of start of any new anticancer therapy for progressive seminoma, assessed up to 20 years after registration]

Time to progression (TTP) [Time Frame: From the date of registration until the date of progressive disease, relapse or death due to progression, whichever occurs first, assessed up to 20 years after registration]

Seminoma-specific survival [Time Frame: From the date of registration until the date of death due to seminoma, assessed up to 20 years after registration]

Secondary ID(s)

2019-000514-11

SAKK 01/18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

German Testicular Cancer Study Group