Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours (P3BEP)
AGCT1532 - Phase 3 Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
-
Clinical Trial Information
Trial Contact: Spinelli, Jennifer; Parker, Melanie; Armatti, Julie M; Doyle, Katherine M; Dubberly, Paige D
Trial Phone: 321.841.5357 ; 321-843-1036 ; 321-843-5284 ; 3218412008 ; 321-841-7561
-
IRB No: AGCT1532
Protocol Abbrev: AGCT1532
Principal Investigator: Amy A. Smith, MD
Phase: Drug: Phase III
Age Group: Pediatric
Secondary Protocol No: ANZUP 1302
Treatment: ◦Drug: Bleomycin (active name: Bleomycin Sulfate) ◦Drug: Etoposide ◦Drug: Cisplatin ◦Drug: Pegylated G-CSF (Pegfilgrastim) ◦Drug: Filgrastim
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT02582697
-
Objective
The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.
-
Key Eligibility
Inclusion Criteria:
1.Age ≥ 11 years and ≤ 45 years on the date of randomisation
2.Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or Exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently
3.Primary arising in testis, ovary, retro-peritoneum, or mediastinum
4.Metastatic disease or non-testicular primary
5.Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries). (See protocol for more information).
6.Adequate bone marrow function with ANC ≥1.0 x 10^9/L, Platelet count ≥100 x 10^9/L
7.Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤2.0 x ULN; ALT and AST must be ≤2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be ≤ 5 x ULN
8.Adequate renal function with estimated creatinine clearance of ≥60 ml/min according to the Cockcroft-Gault formula, unless calculated to be < 60 ml/min or borderline in which case GFR should be formally measured, eg. with EDTA scan
9.ECOG Performance Status of 0, 1, 2, or 3
10.Study treatment both planned and able to start within 14 days of randomisation.
11.Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments
12.Able to provide signed, written informed consent
