Carboplatin chemotherapy and involved node radiotherapy in stage IIA/B seminoma.

• Register: EUCTR
• Last refreshed on: 13 July 2020
• Main ID: EUCTR2011-005840-87-DE
• Date of registration: 08/07/2013
• Prospective Registration: Yes
• Primary sponsor: Swiss Group for Clinical Cancer Research SAKK
• Public title: Carboplatin chemotherapy and involved node radiotherapy in stage IIA/B seminoma.
• Scientific title: Carboplatin chemotherapy and involved node radiotherapy in stage IIA/B seminoma
• Date of first enrolment: 10/10/2013
• Target sample size: 120
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005840-87
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany, Switzerland

Contacts

• Name: Regulatory Affairs
• Affiliation: Monipol

• Name: Regulatory Affairs
• Affiliation: Monipol

Key inclusion & exclusion criteria

Inclusion criteria:
Histologically confirmed classical seminoma treated with primary
inguinal orchidectomy.
Tumor stage at diagnosis or at relapse after primary active surveillance is pT1-4 cN1-2 cM0 according to UICC TNM 2009.
Multi-slice CT or MRI or FDG-PET-CT of the chest, abdomen and pelvis or a FDG-PET-CT within 4 weeks prior to patient registration, showing stage IIA/B disease. I.v. contrast medium has to be administered.
Age = 18 years.
WHO performance status 0-2.
Adequate hematological values: neutrophils = 1.0 x 109/L, platelets =
100x 109/L.
Adequate renal function (calculated creatinine clearance = 50 ml/min,
according to the formula of Cockcroft-Gault.
Patient agrees not to father a child during trial treatment and during 12
months thereafter.
Patient has been proposed sperm conservation.
Patient compliance and geographic proximity allow proper staging and
follow-up for at least 3 years.
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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion criteria:
Previous or concurrent malignancy within 5 years with the exception of localized non-melanoma skin cancer or stage I seminoma for patients entering the trial with relapse during active surveilance.
Psychiatric disorder precluding understanding of information on trial
related topics or giving informed consent or interfering with
compliance for treatment schedule.
Mixed histology seminoma.
Elevated levels of AFP (=ULN) at any time.
Any prior abdominal/pelvic radiotherapy (RT).
Any anti-cancer therapy after primary tumor resection (active surveillance for stage I disease is not considered as a treatment).
Any treatment in a clinical trial within 30 days of trial entry.
Any serious underlying medical condition or serious co-morbidity (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial.
Any contraindication for the trial drug (for example, known hypersensitivity to trial drug or to any other co-component of the trial drug, past or current renal insufficiency, severe hepatic insufficiency, severe bone marrow dysfunction, tumor bleeding, major hearing defects).
Any concomitant drugs contraindicated for use with the trial drug according to the approved product information (for example, nephrotoxic or ototoxic medicines).


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

Patients with seminoma stage IIA/B, after orchidectomy

Intervention(s)

Product Name: Carboplatin
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: Carboplatin
CAS Number: 41575-94-4
Other descriptive name: CARBOPLATIN

Primary Outcome(s)

Secondary Objective: Not applicable

Main Objective: The main objective of this trial is to test the efficacy and safety of
carboplatin chemotherapy and involved node radiotherapy in patients
with stage IIA/B seminoma.

Timepoint(s) of evaluation of this end point: Q3 2021

Primary end point(s): PFS at 3 years

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Q3 2021 and Q3 2038

Secondary end point(s): AEs temporarily associated with the trial treatment
Late AEs
Incidence of secondary malignancies
Response rate
TTP
OS
Seminoma specific survival
PFS
Localization of progression
Method of detection of progression
Development of metabolic syndrome
Development of hypogonadism

Secondary ID(s)

SAKK0110

Source(s) of Monetary Support

Swiss Group for Clinical Cancer Research SAKK

Ethics review

Status: Approved
Approval date: 10/10/2013
Contact: