SAKK 01/18 Radio-chemotherapy with reduced intensity in patients with a seminoma (testicular cancer) of stage IIA/B. A multicenter, open phase II study with two patient groups.
Zusammenfassung der Studie
The study investigates whether and how the treatment of men with a seminoma (testicular cancer) can be improved. In the study, patients are treated with a combination of chemotherapy and radiation therapy with reduced intensity. We want to find out if this form of attenuated therapy is effective compared to the usual therapy, whether potential side effects can be avoided, and how this affects the quality of life of the patients. This study is conducted in Switzerland and Germany. A total of about 135 patients participate. In the study, the drugs Carboplatin (stage IIA) and Cisplatin / Etoposide (stage IIB and IIA) are used as chemotherapy, which are commonly used in Switzerland for the treatment of testicular cancer. The study therapy lasts about six weeks. After that, each participant will be monitored at regular intervals for 20 years.
(BASEC)
Untersuchte Intervention
Participants are assigned to one of two groups. The assignment depends on how advanced the cancer disease is.
Patients in group 1 receive chemotherapy with Carboplatin on the first day. Three weeks later, radiation therapy begins. Patients receive a radiation dose of 2 Gray per day for 12 days (total dose: 24 Gray). The irradiations take place over two weeks and two days, from Monday to Friday. Only the affected lymph nodes are treated specifically. The irradiation lasts 20 minutes each time. The chosen radiation dose is 20% lower than that of standard radiation therapy. The irradiated area corresponds on average to about one third of the area usually irradiated. The chosen chemotherapy is only given outside the study to patients with a seminoma at stage I and is considered significantly weaker, as it consists of only one drug and a single administration.
Patients in group 2 receive chemotherapy with Etoposide and Cisplatin during the first five days. Three weeks later, radiation therapy begins. Patients receive a radiation dose of 2 Gray per day for 15 days (total dose: 30 Gray). The irradiations take place over three weeks, from Monday to Friday. Only the affected lymph nodes are treated specifically. The irradiation lasts 20 minutes each time. The chosen radiation dose is 16.5% lower than that of standard radiation therapy. The irradiated area corresponds on average to about one third of the area usually irradiated. The chosen chemotherapy corresponds in intensity to one quarter of the standard chemotherapy.
After the study therapy, all patients from both groups will be monitored regularly: in the first two years every three months, from the 3rd to the 5th year every six months, from the 6th year to the 20th year once a year.
(BASEC)
Untersuchte Krankheit(en)
Seminoma (testicular cancer) of stage IIA/B
(BASEC)
Men with a seminoma at stage IIA or IIB diagnosed and with the tumor already removed from the affected testicle can participate in the study. Patients must be at least 18 years old. The general condition of the patients must be good enough for them to be able to take care of themselves in daily life (so-called Performance Status 0, 1 or 2). Patients must have no restrictions on organ functions, in particular, they must have good kidney and bone marrow function. Each participant must commit to not fathering a child during the study therapy and in the 12 months thereafter, nor to making sperm donations. (BASEC)
Ausschlusskriterien
Patients with a serious other illness (e.g., severe impairment of kidney or liver function, severe impairment of blood formation in the bone marrow, severe hearing impairment) cannot participate in the study. Similarly, patients who have had further tumor therapy after the surgery of the testicular tumor or who have recently been treated for another tumor disease cannot participate in the study. (BASEC)
Studienstandort
Basel, Bern, Chur, Sion, St Gallen, Winterthur, Zürich
(BASEC)
Sponsor
nicht verfügbar
Kontakt für weitere Auskünfte zur Studie
Allgemeine Auskünfte
Universit?tsspital Basel
(ICTRP)
Wissenschaftliche Auskünfte
Universit?tsspital Basel
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
03.07.2019
(BASEC)
ICTRP Studien-ID
NCT03937843 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
nicht verfügbar
Wissenschaftlicher Titel
Reduced Intensity Radio-chemotherapy for Stage IIA/B Seminoma. A Multicenter, Open Label Phase II Trial With Two Cohorts (ICTRP)
Öffentlicher Titel
Reduced Intensity Radio-chemotherapy for Stage IIA/B Seminoma (ICTRP)
Untersuchte Krankheit(en)
Seminoma;Testicular Cancer (ICTRP)
Untersuchte Intervention
Drug: Carboplatin;Drug: Cisplatin;Drug: Etoposide (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Gender: Male
Maximum age: N/A
Minimum age: 18 Years
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. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Progression free survival (PFS) at 3 years (ICTRP)
Response rate (RR);Progression free survival (PFS);Time to progression (TTP);Overall Survival (OS);Seminoma-specific survival;Time to distant metastasis;Time to next treatment;Localization of progression;Method of detection of progression (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
German Testicular Cancer Study Group (ICTRP)
Weitere Kontakte
Alexandros Papachristofilou, MD, Universit?tsspital Basel (ICTRP)
Sekundäre IDs
2019-000514-11, SAKK 01/18 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT03937843 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar