Reduced Intensity Radio-chemotherapy for Stage IIA/B Seminoma

What this trial studies

Therapy de-escalation in stage IIA/B seminoma represents an unmet need in clinical practice; efficacy of modern standard of care therapies for these patients is high and only a few patients show disease recurrence but short- and long-term toxicities are a major concern. The magnitude of long-term toxicities is often associated with the intensity of the prescribed treatment modality. A higher cumulative dose of chemotherapy agents and radiation dose has been linked to a sharp increase in long-term sequelae. Combining treatment modalities and diversifying toxicity may thus provide an opportunity to limit long-term treatment sequelae. In this trial carboplatin, cisplatin and etoposide are the Investigational Medicine Products (IMPs). They are all medications with a marketing authorization for several solid tumor types and are standard practice in the treatment of testicular cancer in Switzerland and in the European Union (EU). Radiotherapy is also a standard therapy in this indication. However, the trial investigates a stage-adapted (stage IIA or IIB) de-escalation of these standard treatments in the context of a multimodality treatment with chemo- and radiotherapy. The goal is to safely de-escalate treatment while maintaining/enhancing efficacy, which is not a standard practice yet. The SAKK 01/18 trial is designed with the aim to answer these three questions: * Can the dose of involved-node radiotherapy be safely reduced in the context of multimodality treatment with chem…

Who can join: the full rules

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.

Where it's running

• Rotkreuzklinikum München
  München, München, Germany
• Vivantes Klinikum Am Urban
  Berlin, Germany
• Helios Klinikum Berlin-Buch
  Berlin, Germany
• Evang. Kliniken Essen-Mitte
  Essen, Germany
• Universitätsklinikum Hamburg-Eppendorf
  Hamburg, Germany
• ASKLEPIOS Kliniken
  Hamburg, Germany

Study contacts

• Principal investigator: Alexandros Papachristofilou, MD — Universitätsspital Basel

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.