Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00010317

Trial Description

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Title

A Randomized Phase III Study of Sequential High-Dose Cisplatinum/Etoposide/Ifosfamide Plus Stem Cell Support Versus BEP in Patients With Poor Prognosis Germ Cell Cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells.
Peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy
and kill more cancer cells. It is not yet known whether chemotherapy and peripheral stem
cell transplant is more effective than chemotherapy alone.

PURPOSE: This randomized phase III trial is studying how well combination chemotherapy works
when given with peripheral stem cell transplant and how it compares with combination
chemotherapy alone in treating men with previously untreated germ cell cancer.

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Brief Summary in Scientific Language

OBJECTIVES:

- Compare the efficacy of standard cisplatin, etoposide, and ifosfamide (VIP) followed by
sequential high-dose VIP and stem cell rescue versus bleomycin, etoposide, and
cisplatin (BEP) in men with previously untreated poor-prognosis germ cell cancer.

- Compare the acute and late toxicities of these treatment regimens in this patient
population.

- Compare these regimens in terms of failure-free survival, response rate, and overall
survival in these patients.

- Evaluate the quality of life in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, primary mediastinal germ cell tumor (yes vs no), and nonpulmonary visceral
metastases (liver vs bone vs brain). Patients are randomized to one of two treatment arms.

- Arm I: Patients receive etoposide IV over 1 hour followed by cisplatin IV over 1 hour
on days 1-5 and bleomycin IV over 30 minutes on days 2, 8, and 15. Treatment repeats
every 3 weeks for 4 courses.

- Arm II: Patients receive 1 course of standard dose chemotherapy consisting of etoposide
IV over 1 hour followed by cisplatin IV over 1 hour and ifosfamide IV over 1 hour on
days 1-5. Peripheral blood stem cells (PBSC) are harvested around day 12-15. Patients
also receive daily filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing
until PBSC collection is complete.

After day 21, patients receive high-dose chemotherapy consisting of etoposide IV over 1 hour
followed by cisplatin IV over 1 hour, and ifosfamide IV over 1 hour on days -6 through -2.
PBSCs are infused on day 0. Patients receive daily G-CSF subcutaneously beginning on day 1
and continuing through day 19 or until blood counts have recovered. Treatment repeats every
3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before chemotherapy, at 6 months, and at 2 years after
treatment.

Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1
year, every 6 months for 1 year, and annually thereafter.

PROJECTED ACCRUAL: A total of 222 patients (111 per treatment arm) will be accrued for this
study within 2 years.

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Organizational Data

  •   DRKS00010317
  •   2016/04/19
  •   1999/11/01
  •   yes
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Secondary IDs

  •   NCT00003941  (ClinicalTrials.gov)
  •   EORTC-30974  (European Organisation for Research and Treatment of Cancer - EORTC)
  •   EORTC-30974 
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Health Condition or Problem studied

  •   Mediastinal Cancer
  •   Metastatic Cancer
  •   Testicular Germ Cell Tumor
  •   D38.3 -  Neoplasm of uncertain or unknown behaviour: Mediastinum
  •   C62 -  Malignant neoplasm of testis
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Interventions/Observational Groups

  •   Biological: bleomycin sulfate
  •   Biological: filgrastim
  •   Drug: cisplatin
  •   Drug: etoposide
  •   Drug: ifosfamide
  •   Procedure: bone marrow ablation with stem cell support
  •   Procedure: peripheral blood stem cell transplantation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
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  •   Treatment
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  •   III
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Primary Outcome

- Failure-free survival as measured by Logrank at 1 year

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Secondary Outcome

- Complete response as measured by negative tumor markers and no residual masses or viable cancer cells at the end of CT scan or debulking surgery
- Overall survival as measured by Logrank at 2 years
- Quality of life as measured by Quality of Life Questionnaire-Core 30 (QLQ-C30) v3.0 at baseline, at month 6, and at year 2
- Toxicity as measured by NCI-CTC v2.0 after each course, every 6 months up to year 5, and yearly

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Countries of Recruitment

  •   Austria
  •   Belgium
  •   Denmark
  •   Germany
  •   Italy
  •   Netherlands
  •   Norway
  •   Poland
  •   Slovakia
  •   Spain
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   1999/04/30
  •   222
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   16   Years
  •   50   Years
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Additional Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically proven germ cell cancer

- Nonseminoma OR

- Combined seminoma and nonseminoma

- Poor prognosis (nonseminoma):

- Testis/retroperitoneal primary AND

- One of the following poor tumor markers

- AFP greater than 10,000 iu/L

- HCG greater than 50,000 iu/L

- LDH greater than 10 times upper limit of normal OR

- Nonpulmonary visceral metastases (i.e., liver, bone, or brain) OR

- Mediastinal primary

PATIENT CHARACTERISTICS:

Age:

- 16 to 50

Sex:

- Male

Performance status:

- WHO 0-3

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.25 times upper limit of normal (ULN)

- AST no greater than 2 times ULN

Renal:

- Creatinine clearance at least 60 mL/min (unless due to obstructive uropathy
correctable by nephrostomy)

Other:

- No other malignancy except basal cell skin cancer

- No neuropathy

- No other serious illness or medical condition

- No psychological, familial, sociological, or geographical condition that would
prevent compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Concurrent radiotherapy for brain metastases allowed

Surgery:

- Concurrent surgery for brain metastases allowed

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Exclusion Criteria

[---]*

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Addresses

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    • European Organisation for Research and Treatment of Cancer - EORTC
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    • Rigshospitalet, Denmark
    • Gedske Daugaard, MD, DMSc 
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    • Rigshospitalet, Denmark
    • Gedske Daugaard, MD, DMSc 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
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Trial Publications, Results and other Documents

  •   Daugaard G, Skoneczna I, Aass N, De Wit R, De Santis M, Dumez H, Marreaud S, Collette L, Lluch JR, Bokemeyer C, Schmoll HJ. A randomized phase III study comparing standard dose BEP with sequential high-dose cisplatin, etoposide, and ifosfamide (VIP) plus stem-cell support in males with poor-prognosis germ-cell cancer. An intergroup study of EORTC, GTCSG, and Grupo Germinal (EORTC 30974). Ann Oncol. 2011 May;22(5):1054-61. doi: 10.1093/annonc/mdq575. Epub 2010 Nov 8.; 21059637
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2016/07/17


* This entry means the parameter is not applicable or has not been set.