Good Prognosis Germ Cell Trial

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000142639

Enrollment

260

Registered

2005-08-12

Start date

1994-01-05

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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, 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

1. 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 criteria

1. 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.

Outcome results