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Combination Chemotherapy and Radiation Therapy in Treating Patients With Germ Cell Tumors in the Brain

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ClinicalTrials.gov Identifier: NCT00293358
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : September 17, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE February 16, 2006
First Posted Date  ICMJE February 17, 2006
Last Update Posted Date September 17, 2013
Study Start Date  ICMJE January 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2007)
  • Survival
  • Event-free survival
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00293358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy and Radiation Therapy in Treating Patients With Germ Cell Tumors in the Brain
Official Title  ICMJE SIOP Intracranial Germ Cell Tumours Protocol
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, etoposide, ifosfamide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells.

PURPOSE: This phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to radiation therapy alone in treating patients with germ cell tumors in the brain.

Detailed Description

OBJECTIVES:

Primary

  • Evaluate and compare, in a non-randomized protocol, reduced-dose craniospinal radiotherapy alone or combination chemotherapy comprising carboplatin, etoposide phosphate, and ifosfamide and local irradiation in patients with intracranial germinoma.
  • Increase survival with combination chemotherapy comprising cisplatin, etoposide phosphate, and ifosfamide followed by focal radiotherapy or craniospinal irradiation in patients with intracranial secreting germ cell tumors.

Secondary

  • Use the same diagnostic protocol for imaging and laboratory investigations before, during, and after treatment.
  • Establish and use a common documentation system regarding general patient's data, including diagnostic tests, clinical evaluation, surgery, histology, radiotherapy, chemotherapy, and toxicity.
  • Collect information about toxicity, prognostic factors, and tumor markers.
  • Collect epidemiological data, including documentation of incidence and the site and the histologic pattern of intracranial secreting and nonsecreting germ cell tumors in children and adolescents.
  • Register associated malformations in the patients as well as the epidemiology of tumors and malformations in relatives.

OUTLINE: This is a non-randomized, multicenter study. Patients are stratified according to tumor classification (pure CNS germinoma vs secreting germ cell tumor and embryonal carcinoma).

Patients in stratum I undergo biopsy or surgical resection and then begin radiotherapy with or without chemotherapy.

  • Stratum I (pure CNS germinoma [without elevated markers]): Patients receive 1 of 2 treatment options based on national/center standard:

    • Option 1: Patients receive reduced-dose craniospinal radiotherapy 5 days a week for 3 weeks followed by a boost to the tumor bed 5 days a week for 2 weeks. Patients with multifocal or metastatic disease receive additional boosts to the tumor sites.
    • Option 2: Patients receive carboplatin IV over 1 hour on day 1, etoposide phosphate IV over 1 hour on days 1-3 and 22-24, and ifosfamide IV over 3 hours on days 22-26. Treatment repeats every 6 weeks for 2 courses. After recovery from chemotherapy, patients undergo radiotherapy 5 days a week for 5 weeks.
  • Stratum II (secreting tumors and embryonal carcinoma): Patients receive etoposide phosphate IV over 1 hour on days 1-3, cisplatin IV over 1 hour on days 1-5, and ifosfamide IV over 22 hours on days 1-5. Treatment repeats every 3 weeks for up to 4 courses. Patients whose tumor markers do not return to normal after completion of chemotherapy are off protocol. Patients may undergo surgery after chemotherapy course 2 or 4 if required. After completion of chemotherapy and recovery from surgery, patients with nonmetastatic disease undergo radiotherapy to the tumor bed 5 day a week for 6 weeks, and patients with metastatic disease undergo radiotherapy to the cerebrum, spinal axis, and tumor bed for 7 weeks.

After completion of study treatment, patients are followed for 4 weeks and then periodically.

PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Drug: carboplatin
  • Drug: cisplatin
  • Drug: etoposide phosphate
  • Drug: ifosfamide
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 20, 2007)
500
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Clinical and radiological evidence of intracranial germ cell tumor, classified as 1 of the following:

    • Germinoma

      • Pure germinoma
      • Germinoma with mature and/or immature teratoma
    • Secreting germ cell tumor

      • Elevated tumor markers in serum and/or cerebral spinal fluid as evidenced by any of the following:

        • Alpha-fetoprotein > 25 ng/mL
        • β-human choriogonadotropin > 50 IU/L
      • Any tumor containing 1 of these components:

        • Yolk sac tumor
        • Choriocarcinoma
        • Embryonal tumor

          • Normal tumor markers allowed
  • Diagnosis confirmed by histology or elevated serum markers
  • Metastatic or nonmetastatic disease

    • Two separate tumors in the suprasellar and pineal areas without evidence of metastatic disease elsewhere are considered nonmetastatic multifocal disease
  • Study treatment must begin ≤ 4 weeks after diagnosis
  • No pure immature or mature teratomas
  • The following additional patients are eligible:

    • Patients who are > 18 years of age provided no other appropriate protocol exists
    • Patients who were diagnosed > 4 weeks ago
    • Patients who are in relapse

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior treatment except surgery
  • No concurrent amino glycosides or other nephrotoxic drugs during ifosfamide administration
  • No concurrent growth factors
  • No other concurrent chemotherapy or radiotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00293358
Other Study ID Numbers  ICMJE CDR0000455625
CCLG-GC-1997-01
EU-20579
SIOP-CNS-GCT-96
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Children's Cancer and Leukaemia Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: James Nicholson, DM, MA, MRCPCH Cambridge University Hospitals NHS Foundation Trust
Investigator: Marie C. Baranzelli, MD Centre Oscar Lambret
Investigator: U. Gobel, MD Heinrich-Heine University, Duesseldorf
PRS Account National Cancer Institute (NCI)
Verification Date July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP