Therapy De-escalation in Seminoma Stage IIA/B

NCT01593241 | Terminated Phase 2 DMC

• 3 other identifiers: SAKK 01/10345692011-005840-87
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 25

Brief Summary

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.

Conditions

Seminoma

Keywords

Seminoma IIA/B; Carboplatin; RT

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  PFS is defined as the time from registration until one of the following events occurs: * PD or relapse, defined as progression according to the modified trial-specific version of RECIST 1.1 or a rising level of the tumor marker beta-hCG over the ULN (value must be confirmed by a second measurement). Presence of non-seminoma germ cell tumor has to be excluded in the latter case. * Death from any cause.

  at 3 years

Secondary Outcomes (9)

• Adverse events (AEs) temporarily associated with the trial treatment

  at 3 years

• Late AEs

  at the latest at 20 years

• Incidence of secondary malignancies

  at the latest at 20 years

• Response rate

  at 3 years

• Time to progression (TTP)

  at the latest at 20 years

Study Arms (1)

Carboplatin

EXPERIMENTAL

Drug: Carboplatin; Radiation: Involved node RT

Interventions

Carboplatin DRUG

Stage IIA: 1 infusion Carboplatin AUC7 followed by 15 x 2 Gy involved node radiotherapy Stage IIB: 1 infusion Carboplatin AUC7 followed by 18 x 2 Gy involved node radiotherapy

Carboplatin

Involved node RT RADIATION

Involved node RT

Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has given written informed consent before registration.
• 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 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.

You may not qualify if:

• 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 surveillance.
• 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).

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (25)

Aachen Universitätsklinik

Aachen, 52074, Germany

Location

Berlin Universitätsklinik Charité

Berlin, 10117, Germany

Location

Berlin Vivantes - Urban

Berlin, 10967, Germany

Location

Berlin Vivantes - Neukölln

Berlin, 12351, Germany

Location

Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Universitaetsklinikum Düsseldorf

Düsseldorf, D-40225, Germany

Location

Klinik Essen-Mitte

Essen, 45136, Germany

Location

Hamburg Universitätsklinikum - Eppendorf

Hamburg, 20246, Germany

Location

Krefeld Maria-Hilf Krankenhaus

Krefeld, 47805, Germany

Location

Klinikum Harlaching

München, 81545, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Universitätsklinikum Ulm

Ulm, 89075, Germany

Location

Kantonspital Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden

Baden, 5404, Switzerland

Location

Universitaetsspital-Basel

Basel, 4031, Switzerland

Location

Istituto Oncologico della Svizzera Italiana (IOSI)

Bellinzona, CH-6500, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Spitalzentrum Biel

Biel, CH-2501, Switzerland

Location

Kantonsspital Graubuenden

Chur, 7000, Switzerland

Location

Centre Hospitalier Universitaire Vaudois CHUV

Lausanne, CH-1011, Switzerland

Location

Kantonsspital Olten

Olten, CH-4600, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Hopital de Sion

Sion, 1951, Switzerland

Location

Regionalspital Thun

Thun, 3600, Switzerland

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

Related Publications (1)

• Papachristofilou A, Bedke J, Hayoz S, Schratzenstaller U, Pless M, Hentrich M, Krege S, Lorch A, Aebersold DM, Putora PM, Berthold DR, Zihler D, Zengerling F, Dieing A, Mueller AC, Schaer C, Biaggi C, Gillessen S, Cathomas R. Single-dose carboplatin followed by involved-node radiotherapy for stage IIA and stage IIB seminoma (SAKK 01/10): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022 Nov;23(11):1441-1450. doi: 10.1016/S1470-2045(22)00564-2. Epub 2022 Oct 10.

  PMID: 36228644 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Seminoma

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Germinoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Alexandros Papachristofilou, MD

  University Hospital, Basel, Switzerland

  STUDY CHAIR

• Richard Cathomas, MD

  Cantonal Hospital Graubünden

  STUDY CHAIR

• Jens Bedke, Prof

  D - University Hospital Tübingen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: May 8, 2012
• Study Start: June 15, 2012
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12); CH (13)