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A Single Group Trial Evaluating One Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Tumours of the Testis (NSGCTT)


Phase 3
16 Years
N/A
Open (Enrolling)
Male
Stage I Testicular Non-Seminomatous Germ Cell Tumor

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Trial Information

A Single Group Trial Evaluating One Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Tumours of the Testis (NSGCTT)


Inclusion Criteria:



- Histologically proven non-seminomatous germ cell tumour of combined GCT (NSGCT +
seminoma)of the testis

- Histologically proven vascular invasion of the primary tumour into the testicular
veins or lymphatics

- Clinical stage 1 patients (normal AFP and HCG, or optimum marker decline approaching
normal levels after orchidectomy AND no evidence of metastases on CT of chest,
abdomen and pelvis)

- Men aged 16 years or over

- Creatinine clearance > 50 ml/min

- No previous chemotherapy

- WBC > 1.5 x 10^9/l and platelets 100 x 10^9/l

- Fit to receive chemotherapy

- Able to start BEP(500) chemotherapy as part of 111 study within 6* weeks of
orchidectomy

- Written informed consent *If there are unavoidable delays this timescale can be
extended to 8 weeks

Exclusion Criteria:

- All patients with pure seminoma

- All patients with non-seminoma or combined NSGCT + seminoma > stage 1

- All patients with no vascular invasion

- Previous chemotherapy

- Patients with second malignancy except contralateral TIN and contralateral germ cell
tumour treated by orchidectomy and subsequent surveillance of more than 3 years

- Co-morbidity precluding the safe administration of BEP(500) chemotherapy

- Patients with renal function impairment (bilirubin >1.25 x ULN and/or AST >2 x ULN)

- Patients with pre-existing neuropathy

- Patients with pulmonary fibrosis

- Patients with serious illness or medical conditions incompatible with the protocol

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recurrence

Outcome Description:

To demonstrate that one cycle of adjuvant BEP(500) reduces 2 year recurrence rate to less than 5%

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Professor Michael Cullen

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospitals Birmingham NHS Foundation Trust

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

ICR-CTSU/2008/10019

NCT ID:

NCT01726374

Start Date:

February 2010

Completion Date:

August 2019

Related Keywords:

  • Stage I Testicular Non-Seminomatous Germ Cell Tumor
  • Neoplasms, Germ Cell and Embryonal

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