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Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors

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Trial Identification

Brief Title: Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors

Official Title: Randomized Phase II Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors

Study ID: NCT00301782

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as cisplatin, vincristine, bleomycin, carboplatin, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating germ cell tumors. PURPOSE: This randomized phase II trial is studying two different combination chemotherapy regimens to compare how well they work in treating male patients with germ cell tumors.

Detailed Description: OBJECTIVES: Primary * Compare the response rate in patients with poor-prognosis extracranial nonseminoma germ cell tumors treated with intensive induction chemotherapy comprising cisplatin, vincristine, bleomycin, and carboplatin followed by bleomycin, etoposide phosphate, and cisplatin (BEP) vs standard BEP chemotherapy. Secondary * Compare overall and progression-free survival of patients treated with these regimens. * Compare the toxicity of these regimens in these patients. OUTLINE: This is a multicenter, open-label, randomized study. Patients are stratified according to participating center, pre-protocol low-dose chemotherapy (yes vs no), and other clinically important factors. Patients are randomized to 1 of 2 treatment arms. * Arm I (BEP): Patients receive bleomycin IV over 15 minutes once on day 1 or 2 and days 8 and 15 and etoposide phosphate IV over 1 hour and cisplatin IV over 4 hours on days 1-5. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. * Arm II (CBOP/BEP): Patients receive chemotherapy according to the following schedule: * Weeks 1-6: Patients receive cisplatin IV over 6 hours on days 1, 2, 8, 15, 16, and 22 (OR over 4 hours on days 1-5 and 15-19); vincristine IV on days 1, 8, 15, 22, 29, and 36; bleomycin IV over 15 minutes on days 1, 15, 29, and 36 and bleomycin IV continuously on days 8-12 and 22-25; and carboplatin IV over 30-60 minutes on days 8 and 22. * Weeks 7-15: Patients receive bleomycin IV continuously on days 1-5, 8-12, and 15-19 and etoposide phosphate IV over 1 hour and cisplatin IV over 4 hours on days 1-5. Treatment repeats every 21 days for 4 courses. After completion of study treatment, patients are followed periodically for 5 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust, Birmingham, England, United Kingdom

Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom

Addenbrooke's Hospital, Cambridge, England, United Kingdom

Gloucestershire Oncology Centre at Cheltenham General Hospital, Cheltenham, England, United Kingdom

Walsgrave Hospital, Coventry, England, United Kingdom

Royal Devon and Exeter Hospital, Exeter, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

Leicester Royal Infirmary, Leicester, England, United Kingdom

Saint Bartholomew's Hospital, London, England, United Kingdom

University College of London Hospitals, London, England, United Kingdom

Christie Hospital, Manchester, England, United Kingdom

Clatterbridge Centre for Oncology, Merseyside, England, United Kingdom

Nottingham City Hospital, Nottingham, England, United Kingdom

Rosemere Cancer Centre at Royal Preston Hospital, Preston, England, United Kingdom

Berkshire Cancer Centre at Royal Berkshire Hospital, Reading, England, United Kingdom

Southampton General Hospital, Southampton, England, United Kingdom

Royal Marsden - Surrey, Sutton, England, United Kingdom

Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom

Raigmore Hospital, Inverness, Scotland, United Kingdom

Velindre Cancer Center at Velindre Hospital, Cardiff, Wales, United Kingdom

Contact Details

Name: Robert A. Huddart, MD

Affiliation: Royal Marsden NHS Foundation Trust

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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