Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT00293358
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2006-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Patients With Germ Cell Tumors in the Brain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C061400', 'term': 'etoposide phosphate'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2006-02-16', 'studyFirstSubmitQcDate': '2006-02-16', 'lastUpdatePostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival'}, {'measure': 'Event-free survival'}]}, 'conditionsModule': {'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'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'referencesModule': {'references': [{'pmid': '33633029', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* 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.\n* 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.\n\nSecondary\n\n* Use the same diagnostic protocol for imaging and laboratory investigations before, during, and after treatment.\n* Establish and use a common documentation system regarding general patient's data, including diagnostic tests, clinical evaluation, surgery, histology, radiotherapy, chemotherapy, and toxicity.\n* Collect information about toxicity, prognostic factors, and tumor markers.\n* 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.\n* Register associated malformations in the patients as well as the epidemiology of tumors and malformations in relatives.\n\nOUTLINE: 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).\n\nPatients in stratum I undergo biopsy or surgical resection and then begin radiotherapy with or without chemotherapy.\n\n* Stratum I (pure CNS germinoma \\[without elevated markers\\]): Patients receive 1 of 2 treatment options based on national/center standard:\n\n * 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.\n * 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.\n* 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.\n\nAfter completion of study treatment, patients are followed for 4 weeks and then periodically.\n\nPROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Clinical and radiological evidence of intracranial germ cell tumor, classified as 1 of the following:\n\n * Germinoma\n\n * Pure germinoma\n * Germinoma with mature and/or immature teratoma\n * Secreting germ cell tumor\n\n * Elevated tumor markers in serum and/or cerebral spinal fluid as evidenced by any of the following:\n\n * Alpha-fetoprotein \\> 25 ng/mL\n * β-human choriogonadotropin \\> 50 IU/L\n * Any tumor containing 1 of these components:\n\n * Yolk sac tumor\n * Choriocarcinoma\n * Embryonal tumor\n\n * Normal tumor markers allowed\n* Diagnosis confirmed by histology or elevated serum markers\n* Metastatic or nonmetastatic disease\n\n * Two separate tumors in the suprasellar and pineal areas without evidence of metastatic disease elsewhere are considered nonmetastatic multifocal disease\n* Study treatment must begin ≤ 4 weeks after diagnosis\n* No pure immature or mature teratomas\n* The following additional patients are eligible:\n\n * Patients who are \\> 18 years of age provided no other appropriate protocol exists\n * Patients who were diagnosed \\> 4 weeks ago\n * Patients who are in relapse\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior treatment except surgery\n* No concurrent amino glycosides or other nephrotoxic drugs during ifosfamide administration\n* No concurrent growth factors\n* No other concurrent chemotherapy or radiotherapy'}, 'identificationModule': {'nctId': 'NCT00293358', 'briefTitle': 'Combination Chemotherapy and Radiation Therapy in Treating Patients With Germ Cell Tumors in the Brain', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'SIOP Intracranial Germ Cell Tumours Protocol', 'orgStudyIdInfo': {'id': 'CDR0000455625'}, 'secondaryIdInfos': [{'id': 'CCLG-GC-1997-01'}, {'id': 'EU-20579'}, {'id': 'SIOP-CNS-GCT-96'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'etoposide phosphate', 'type': 'DRUG'}, {'name': 'ifosfamide', 'type': 'DRUG'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'neoadjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12', 'city': 'Dublin', 'country': 'Ireland', 'facility': "Our Lady's Hospital for Sick Children", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': 'B4 6NH', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': "Birmingham Children's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BS2 8AE', 'city': 'Bristol', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Institute of Child Health at University of Bristol', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': "Leeds Cancer Centre at St. James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'L12 2AP', 'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'facility': "Royal Liverpool Children's Hospital, Alder Hey", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'E1 1BB', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1N 3JH', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital for Children NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M27 4HA', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': "Central Manchester and Manchester Children's University Hospitals NHS Trust", 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Sir James Spence Institute of Child Health', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'state': 'England', 'country': 'United Kingdom', 'facility': "Queen's Medical Centre", 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': '0X3 9DU', 'city': 'Oxford', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Oxford Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'S10 2TH', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': "Children's Hospital - Sheffield", 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Foundation Trust - Surrey', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'BT12 6BE', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Royal Belfast Hospital for Sick Children', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'AB25 2ZG', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': "Royal Aberdeen Children's Hospital", 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'EH9 1LF', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Hospital for Sick Children', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G3 8SJ', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Hospital for Sick Children', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Childrens Hospital for Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'James Nicholson, DM, MA, MRCPCH', 'role': 'STUDY_CHAIR', 'affiliation': 'Cambridge University Hospitals NHS Foundation Trust'}, {'name': 'Marie C. Baranzelli, MD', 'affiliation': 'Centre Oscar Lambret'}, {'name': 'U. Gobel, MD', 'affiliation': 'Heinrich-Heine University, Duesseldorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Cancer and Leukaemia Group", 'class': 'OTHER'}}}}