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

NCT00293358 | Completed Phase 3

• 4 other identifiers: CDR0000455625CCLG-GC-1997-01EU-20579SIOP-CNS-GCT-96
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 21

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood central nervous system germ cell tumor; adult central nervous system germ cell tumor; childhood central nervous system choriocarcinoma; childhood central nervous system embryonal tumor; childhood central nervous system yolk sac tumor

Outcome Measures

Primary Outcomes (2)

• Survival

• Event-free survival

Interventions

carboplatin DRUG

cisplatin DRUG

etoposide phosphate DRUG

ifosfamide DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

Study Sites (21)

Our Lady's Hospital for Sick Children

Dublin, 12, Ireland

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

Location

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Royal London Hospital

London, England, E1 1BB, United Kingdom

Location

Great Ormond Street Hospital for Children NHS Trust

London, England, WC1N 3JH, United Kingdom

Location

Central Manchester and Manchester Children's University Hospitals NHS Trust

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Related Publications (1)

• Rajagopal R, Leong SH, Jawin V, Foo JC, Ahmad Bahuri NF, Mun KS, Azman RR, Loh J, Yap TY, Ariffin H, Moreira DC, Gottardo NG, Bouffet E, Ganesan D. Challenges in the Management of Childhood Intracranial Germ Cell Tumors in Middle-Income Countries: A 20-Year Retrospective Review From a Single Tertiary Center in Malaysia. J Pediatr Hematol Oncol. 2021 Oct 1;43(7):e913-e923. doi: 10.1097/MPH.0000000000002116.

  PMID: 33633029 DERIVED

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Carboplatin; Cisplatin; etoposide phosphate; Ifosfamide; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• James Nicholson, DM, MA, MRCPCH

  Cambridge University Hospitals NHS Foundation Trust

  STUDY CHAIR

• Marie C. Baranzelli, MD

  Centre Oscar Lambret

• U. Gobel, MD

  Heinrich-Heine University, Duesseldorf

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: February 17, 2006
• Study Start: January 1, 1997
• Study Completion: December 1, 2006
• Last Updated: September 17, 2013

Record last verified: 2008-07

Locations

GB (20); IE (1)