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SNCTP000002278 | NCT02375204 | BASEC2016-01487

Die TIGER Studie zum Vergleich der Wirksamkeit und Verträglichkeit von vier Zyklen einer intensiven Chemotherapie in herkömmlicher Menge mit einer "Hochdosis-Chemotherapie" und autologer Stammzelltransplantation

Datenbasis: BASEC (Import vom 19.10.2021), WHO (Import vom 18.04.2021)
Geändert: 21.03.2021
Krankheitskategorie: Anderer Krebs

Zusammenfassende Beschreibung der Studie (Datenquelle: BASEC)

Die TIGER Studie ist eine Untersuchung, bei der zwei seit Jahren in der Routine eingesetzten Therapieverfahren bezüglich ihrer Wirksamkeit und Verträglichkeit miteinander verglichen werden. Das eine Verfahren beinhaltet vier Zyklen einer intensiven Chemotherapie in herkömmlicher Menge. Bei dem anderen Verfahren wird die Chemotherapie in der Menge deutlich gesteigert, was die Übertragung von blutbildenden Vorläuferzellen erfordert (sogenannte "Hochdosis-Chemotherapie mit autologer Stammzelltransplantation")

Untersuchte Krankheiten (Datenquelle: BASEC)

Krebsgewebe von Keimzellen der Hoden oder ausserhalb der Hoden, das sich im Körper eines Menschen ausgebreitet hat, und trotz einer verabreichten Chemotherapie nicht vollständig geheilt werden konnte bzw. das nach zunächst erfolgreicher Therapie wieder aufgetreten ist.

Health conditions (Datenquelle: WHO)

Germ Cell Tumor;Teratoma;Choriocarcinoma;Germinoma;Mixed Germ Cell Tumor;Yolk Sac Tumor;Childhood Teratoma;Malignant Germ Cell Neoplasm;Extragonadal Seminoma;Non-seminomatous Germ Cell Tumor;Seminoma

Seltene Krankheit (Datenquelle: BASEC)

Nein

Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne) (Datenquelle: BASEC)

Herkömmliche Therapie: Vier Zyklen einer Chemotherapie mit den Medikamenten Cisplatin, Ifosfamid und Paclitaxel im Abstand von 21 Tagen.

Hochdosis-Chemotherapie: Zwei Zyklen einer Chemotherapie mit den Medikamenten Ifosfamid und Paclitaxel in herkömmlicher Menge im Abstand von 14 Tagen, gefolgt von drei Zyklen mit den Medikamenten Carboplatin und Etoposid in hoher Dosierung im Abstand von 28 Tagen.

Interventions (Datenquelle: WHO)

Drug: paclitaxel;Drug: ifosfamide;Drug: cisplatin;Drug: pegylated G-CSF;Drug: G-CSF;Drug: carboplatin;Drug: etoposide phosphate;Procedure: stem cell reinfusion

Kriterien zur Teilnahme an der Studie (Datenquelle: BASEC)

1. Durch pathologische Überprüfung im einschließenden Studienzentrum histologisch gesicherter Keimzelltumor
2. Nachweislich progredienter oder rezidivierender Keimzelltumor
3. Es müssen als Teil der Erstlinien-Chemotherapie 3-6 Zyklen Cisplatin-basierter Chemotherapie verabreicht worden sein
4. Keine vorhergehende Behandlung mit einer hoch-dosierten Chemotherapie
5. Ein körperlicher Gesundheitsstatus nach "ECOG" von 0 bis 2
6. Keine zeitgleich vorliegenden weitere Krebserkrankungen

Ausschlusskriterien (Datenquelle: BASEC)

Alle Patienten, bei denen die obigen Einschlusskriterien nicht zutreffen, können nicht im Rahmen der TIGER Therapiestudie behandelt werden.

Inclusion/Exclusion Criteria (Datenquelle: WHO)


1. Documentation of Disease

- Histologic Documentation: Confirmation of GCT histology (both seminoma and
nonseminoma) on pathologic review at the center of enrollment.

- Tumor may have originated in any primary site. NOTE: In rare circumstances,
patients will be allowed to enroll even if a pathologic diagnosis may not have
been established.

- This would require a clinical situation consistent with the diagnosis of GCT
(testicular, peritoneal, retroperitoneal or mediastinal mass, elevated tumor
marker levels {HCG = 500; AFP = 500} and typical pattern of metastases)

2. Evidence of Disease

- Must have evidence of progressive or recurrent GCT (measurable or non-measurable)
following one line of cisplatin-based chemotherapy, defined as meeting at least
one of the following criteria:

- Tumor biopsy of new or growing or unresectable lesions demonstrating viable
non-teratomatous GCT (enrollment on this study for adjuvant treatment after
macroscopically complete resection of viable GCT is not allowed). In the
event of an incomplete gross resection where viable GCT is found, patients
will be considered eligible for the study.

- Consecutive elevated serum tumor markers (HCG or AFP) that are increasing.
Increase of an elevated LDH alone does not constitute progressive disease.

- Development of new or enlarging lesions in the setting of persistently
elevated HCG or AFP, even if the HCG and AFP are not continuing to increase.

3. Prior Treatment

- Must have received 3-6 cycles of cisplatin-based chemotherapy as part of
first-line (initial) chemotherapy.

- Prior POMBACE, CBOP-BEP, or GAMEC are allowed.

- Note: For patients requiring immediate treatment, 1 cycle of
conventional-dose salvage chemotherapy is allowed. Therefore, these patients
may have received 7 prior cycles of chemotherapy. 6 cycles as part of
first-line chemotherapy and 1 cycle of salvage conventional chemotherapy.

- No more than one prior line of chemotherapy for GCT (other than the 1 cycle of
salvage chemotherapy as defined in the protocol)

- Definition of one line of chemotherapy: One line of therapy can in some
cases consist of 2 different cisplatin-based treatment combinations,
provided there is no disease progression between these two regimens.

- Prior treatment with carboplatin as adjuvant therapy is allowed, provided
patients meet other eligibility criteria (e.g., the patient has also
received 3-4 cycles of cisplatin-based chemotherapy).

- Prior treatment with 1-2 cycles of BEP or EP as adjuvant chemotherapy for
early stage GCT is allowed, provided the patient also received 3-4 cycles of
BEP or EP again at relapse. Patients treated with 3-4 cycles of VIP at
relapse following 1-2 cycles of BEP/EP are not eligible as this would be
considered more than 1 line of prior therapy.

- No prior treatment with high-dose chemotherapy (defined as treatment utilizing
stem cell rescue)

- No prior treatment with TIP with the exception when given as a bridge to
treatment on protocol for patients with rapidly progressive disease who cannot
wait to complete the eligibility screening process. Only one cycle is allowed.

- No concurrent treatment with other cytotoxic drugs or targeted therapies.

- No radiation therapy (other than to the brain) within 14 days of day 1 of
protocol chemotherapy except radiation to brain metastases, which must be
completed 7 days prior to start of chemotherapy.

- No previous chemotherapy within 17 days prior to enrollment. A minimum of three
weeks after the last day of the start of the previous chemotherapy regimen before
the first day of chemotherapy on study protocol.

- Must have adequate recovery from prior surgery (eg, healed scar, resumption of
diet)

4. Age = 14 years (= 18 years in Germany)

5. ECOG Performance Status 0 to 2

6. Male gender

7. Required Initial Laboratory Values:

- Absolute Neutrophil Count (ANC) = 1,500/mm^3

- Platelet Count = 100,000/mm^3

- Calculated creatinine clearance = 50 mL/min

- Bilirubin = 2.0 x upper limits of normal (ULN)

- AST/ALT = 2.5 x upper limits of normal (ULN)

8. No concurrent malignancy other than non-melanoma skin cancer, superficial noninvasive
(pTa or pTis) TCC of the bladder, contralateral GCT, or intratubular germ cell
neoplasia. Patients with a prior malignancy, but at least 2 years since any evidence
of disease are allowed.

9. Negative Serology (antibody test) for the following infectious diseases:

- Human Immunodeficiency Virus (HIV) type 1 and 2

- Human T-cell Leukemia Virus (HTLV) type 1 and 2 (mandatory in US but optional in
Canada and Europe)

- Hepatitis B surface antigen

- Hepatitis C antibody

10. No late relapse with completely surgically resectable disease. Patients with late
relapses (defined as relapse = 2 years from the date of completion of the last
chemotherapy regimen) whose disease is completely surgically resectable are not
eligible. Patients with late relapses who have unresectable disease are eligible.

11. No large (= 2 cm) hemorrhagic or symptomatic brain metastases until local treatment
has been administered (radiation therapy or surgery). Treatment may begin = 7 days
after completion of local treatment. Patients with small (< 2 cm) and asymptomatic
brain metastases are allowed and may be treated with radiation therapy and/or surgery
concurrently with Arm A or cycles 1 and 2 of Arm B if deemed medically indicated.

Radiation therapy should not be given concurrently with high-dose carboplatin or
etoposide.

12. No secondary somatic malignancy arising from teratoma (e.g., teratoma with malignant
transformation) when it is actively part of the disease recurrence or progression.

Weitere Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/show/NCT02375204

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02375204

Weitere Informationen zur Studie

Registrationsdatum der Studie

20.02.2015

Einschluss der ersten teilnehmenden Person

01.03.2015

Rekrutierungsstatus

Recruiting

Wissenschaftlicher Titel (Datenquelle: WHO)

A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

Studientyp (Datenquelle: WHO)

Interventional

Design der Studie (Datenquelle: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Datenquelle: WHO)

Phase 3

Primäre Endpunkte (Datenquelle: WHO)

overall survival

Sekundäre Endpunkte (Datenquelle: WHO)

progression free survival;proportion of patients achieving either a complete response (CR) or partial response;treatment related mortality;number of participants with treatment-related adverse events as assessed by CTCAE v4.0;Validation of International Prognostic Factor Study Group stratification system (eg, primary site, prior response, progression free interval)

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

noch keine Angaben verfügbar

Link zu den Ergebnissen im Primärregister

noch keine Angaben verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

noch keine Angaben verfügbar

Studiendurchführungsorte

Durchführungsorte in der Schweiz (Datenquelle: BASEC)

Bern, Genf, Zürich

Durchführungsländer (Datenquelle: WHO)

Australia, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States

Kontakt für weitere Auskünfte zur Studie

Angaben zur Kontaktperson in der Schweiz (Datenquelle: BASEC)

Prof. Dr. Jörg Beyer
+41 31 6322111
joerg.beyer@insel.ch

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Darren Feldman, MD
Memorial Sloan Kettering Cancer Center
646 422-4491

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Darren Feldman, MD
Memorial Sloan Kettering Cancer Center
646 422-4491

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

Alliance for Clinical Trials in Oncology

Weitere Sponsoren (Datenquelle: WHO)

National Cancer Institute (NCI);European Organisation for Research and Treatment of Cancer - EORTC;Movember Foundation;Institute of Cancer Research (ICR), United Kingdom;Cancer Research UK;UNICANCER;Irish Group CTI

Bewilligung durch Ethikkommission (Datenquelle: BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Kantonale Ethikkommission Zürich

Datum der Bewilligung durch die Ethikkommission

22.05.2017

Weitere Studienidentifikationsnummern

Studienidentifikationsnummer der Ethikkommission (BASEC-ID) (Datenquelle: BASEC)

2016-01487

Secondary ID (Datenquelle: WHO)

U10CA180821
NCI-2014-01696
A031102