Reduced Intensity Radio-chemotherapy for Stage IIA/B Seminoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2046
  • participants needed
    135
  • sponsor
    Swiss Group for Clinical Cancer Research
Updated on 12 February 2022
platelet count
etoposide
neutrophil count
carboplatin
orchiectomy
renal function tests
fdg-pet
cisplatin etoposide
seminoma

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.

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).

Details
Condition Seminoma, Testicular Cancer
Treatment cisplatin, etoposide, carboplatin
Clinical Study IdentifierNCT03937843
SponsorSwiss Group for Clinical Cancer Research
Last Modified on12 February 2022

Eligibility

Yes No Not Sure

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
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