Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours

Launched by UNIVERSITY OF SYDNEY · Oct 19, 2015

Keywords

ClinConnect Summary

This clinical trial is looking to find out if a faster treatment method called accelerated BEP chemotherapy works better than the standard BEP chemotherapy for men with certain types of cancer called metastatic germ cell tumors, particularly those with intermediate or poor risk. The trial is currently recruiting participants aged between 11 and 50 years who have been diagnosed with these tumors. To qualify, participants need to have specific types of germ cell tumors that have spread in their body, and they must meet certain health criteria to ensure they can safely receive the treatment.

If you or someone you know is eligible and chooses to participate, they can expect to be randomly assigned to either the accelerated treatment or the standard treatment. Throughout the trial, participants will receive regular health assessments to monitor their progress. It’s also important to know that men involved in the study will need to use effective contraception during and after the treatment period to prevent pregnancy. This trial aims to improve outcomes for patients with this type of cancer, so participation could contribute to important findings in cancer treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 11 years and ≤ 50 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
• Exclusion Criteria:
• • 1. Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)
• • 2. Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient hasb. non-seminoma by IGCCC criteria or stage IV malignant ovarian germ cell tumour in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (eg. organ failure, vena cava obstruction, overwhelming burden of disease). Acceptable regimens include cisplatin 20 mg/m2 days 1-2 and etoposide 100 mg/m2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m2 days 1-2; or baby-BOP.43 Patients must meet all other inclusion and exclusion criteria at the time of registration.
• • Additionally participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation. Such patients must be discussed with the coordinating centre prior to registration, and must be registered within 10 days of commencing study chemotherapy.
• • 3. Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
• • 4. Significant co-morbid respiratory disease that contraindicates the use of bleomycin
• • 5. Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus
• • 6. Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
• • 7. Inadequate contraception. Men must use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy.
• • 8. Known allergy or hypersensitivity to any of the study drugs
• • 9. Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
• • The above inclusion and exclusion criteria will apply to stage 1 (n=150) and stage 2 (n=500 including stage 1) of the study. All sites will participate in both stages of the study with the exception of the Children's Oncology Group who will be participate in stage 1 only.