ActivePhase 3ACTRN12605000142639

Good Prognosis Germ Cell Trial

Randomised, Phase III, trial for good prognosis germ cell tumours comparing two different regimes of cisplatin, etoposide and bleomycin.

Sponsor

Australian and New Zealand Germ Cell Trials Group at NHMRC Clinical Trials Centre

Enrollment

260 participants

Start Date

Jan 5, 1994

Study Type

Interventional

Conditions

Histologically confirmed germ cell tumour (seminoma or non-seminoma) with measurable disease or raised concentrations of tumor markers in serum.

Eligibility

Sex: Both males and females

Inclusion Criteria1

Histologically confirmed germ cell tumour.2. All patients have measureable disease 3. Patients with pure and non-seminomatous arising at any site defined as good risk by the MSKCC classification. 4. no prior chemotherapy.

Exclusion Criteria1

Germ cell tumours not arising in the testes, retroperitoneum or mediastinum. 2. Patients classified to have poor prognosis according to the International Germ Cell Consensus Classification. 3. Patients with cerebral metastases.4. Previous or current second malignancy.

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Interventions

A multicentre randomised trial to compare two standard chemotherapy regimens for men with good prognosis germ cell tumours. Treatment arm A and B both consisted of cisplatin, etoposide and bleomycin,

A multicentre randomised trial to compare two standard chemotherapy regimens for men with good prognosis germ cell tumours. Treatment arm A and B both consisted of cisplatin, etoposide and bleomycin, but was different in doses and the number of cycles. The trial was stopped when the second planned interim analysis met predefined stopping rules. Overall survival was substantially better with treatment arm A.

Locations(1)

Australia

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ACTRN12605000142639