Clinical trial · Interventional
Therapy De-escalation in Seminoma Stage IIA/B
Carboplatin Chemotherapy and Involved Node Radiotherapy in Stage IIA/B Seminoma
NCT01593241CI-TRIAL-00085965terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Board decided to prematurely terminate the follow-up phase of the trial due to funding reasons
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Seminoma | Seminoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Involved node RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carboplatin
- interventionNames
- Drug: Carboplatin
- Radiation: Involved node RT
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- at 3 years
- description
- 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.
Secondary outcomes (9)
- measure
- Adverse events (AEs) temporarily associated with the trial treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. 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 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).
References
Publications (1)
- DERIVEDPapachristofilou 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