NCT03937843

Reduced Intensity Radio-chemotherapy for Stage IIA/B Seminoma

Reduced Intensity Radio-chemotherapy for Stage IIA/B Seminoma. A Multicenter, Open Label Phase II Trial With Two Cohorts

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial investigates a stage-adapted (stage IIA or IIB) de-escalation of the standard treatments in the context of a multimodality treatment with chemo- and radiotherapy in seminoma patients. The goal is to safely de-escalate treatment while maintaining/enhancing efficacy, which is not a standard practice yet.

Detailed description

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 chemo- and radiotherapy? * Can a more potent chemotherapy in the form of cisplatin/etoposide reduce the rate of distant failure in comparison to carboplatin? * Can a combination of cisplatin/etoposide and involved-node radiotherapy pose a potent treatment regime for patients with recurrence after adjuvant carboplatin or radiotherapy for stage I seminoma? Furthermore, as active surveillance is becoming standard of care in stage I seminoma, it is projected that the amount of patients in need of treatment with stage IIA/B disease will rise, due to more patients developing disease progression during active surveillance. The trial design, trial treatment and trial specifics are a consensus among the Swiss Urogenital Tumors Project Group and the Swiss Radio-oncology Section from the Swiss Group for Clinical Cancer Research (SAKK) and the German Testicular Cancer Study Group (GTCSG).

Conditions

• Seminoma
• Testicular Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	Patients in cohort 1 will receive a 60-minute i.v. infusion of carboplatin AUC 7 at day 1 of treatment.
DRUG	Cisplatin	Patients in cohort 2 will receive on day 1 to day 5: * a 60-minutes i.v. infusion of etoposide 100mg/m2 per day followed by * a 60-120 minutes i.v. infusion of cisplatin 20mg/m2 per day.
DRUG	Etoposide	Patients in cohort 2 will receive on day 1 to day 5: * a 60-minutes i.v. infusion of etoposide 100mg/m2 per day followed by * a 60-120 minutes i.v. infusion of cisplatin 20mg/m2 per day.

Timeline

• Start date: 2019-07-29
• Primary completion: 2026-12-31
• Completion: 2046-12-31
• First posted: 2019-05-06
• Last updated: 2026-01-20

Locations

19 sites across 2 countries: Germany, Switzerland