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Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors

StatusActive, Not Recruiting
PhasePhase 3
Started2015-08-06
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 65 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-06-15
Study Identification, Study Status, Contacts/Locations v64
Study sitesdetails revised at 1 of 125 sites
Study titlerevised
[...] Chemotherapy and Stem Cell Transplant in Treating Patients withWith Relapsed or Refractory Germ Cell Tumors
2025-01-09
Study Identification, Study Status, Contacts/Locations v63
Primary completion date2024-06→2031-06-01
Completion date2024-06→2031-06-01
Start date2015-08-05→2015-08-06
Study sitesdetails revised at 1 of 125 sites
Study titlerevised
[...] Chemotherapy and Stem Cell Transplant in Treating Patients Withwith Relapsed or Refractory Germ Cell Tumors
2023-08-30
Study Status, Contacts/Locations v62
Study sites125 entries, revised
MetroUniversity of Michigan Health Hospital- West
2023-03-16
Study Status v61
Re-verified, no change to tracked fields
2023-03-14
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v60
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 125 of 125 sites
Show 45 earlier versions
2022-12-14
Study Status v59
Completion datenot stated→2024-06
Start date2015-03→2015-08-05
2022-09-25
Study Status, Contacts/Locations v58
Study sitesdetails revised at 6 of 125 sites
2022-08-02
Study Status, Contacts/Locations v57
Study sites124→125
2022-07-15
Study Status, Contacts/Locations v56
Study sites124 entries, revised
Marshfield ClinicMedical Center-River Region at Stevens Point Center
2022-06-03
Study Status, Contacts/Locations v55
Study sitesdetails revised at 4 of 124 sites
2022-04-18
Study Status, Contacts/Locations v54
Study sites123→124
2022-03-22
Study Status, Contacts/Locations v53
Study sites122→123
2022-02-16
Study Status, Contacts/Locations v52
Study sitesdetails revised at 15 of 122 sites
2022-01-11
Study Status, Contacts/Locations v51
Study sitesdetails revised at 7 of 122 sites
2021-12-13
Study Status, Contacts/Locations v50
Study sitesdetails revised at 6 of 122 sites
2021-11-11
Study Status, Contacts/Locations v49
Study sites119→122
2021-10-11
Study Status, Contacts/Locations v48
Study sitesdetails revised at 17 of 119 sites
2021-08-25
Study Status, Contacts/Locations v47
Study sitesdetails revised at 1 of 119 sites
2021-08-16
Study Status, Contacts/Locations v46
Study sitesdetails revised at 17 of 119 sites
2021-07-19
Study Status, Contacts/Locations v45
Study sitesdetails revised at 4 of 119 sites
2021-06-09
Study Status, Contacts/Locations v44
Study sites116→119
2021-03-05
Study Status, Contacts/Locations v43
Study sitesdetails revised at 9 of 116 sites
2021-02-05
Study Status, Contacts/Locations v42
Study sitesdetails revised at 5 of 116 sites
2021-01-08
Study Status, Contacts/Locations v41
Study sites115→116
2020-11-10
Study Status, Contacts/Locations v40
Study sites114→115
2020-10-08
Study Status, Contacts/Locations v39
Study sitesdetails revised at 2 of 114 sites
2020-09-03
Study Status, Contacts/Locations v38
Study sites113→114
2020-07-22
Study Status, Contacts/Locations v37
Study sites112→113
2020-06-03
Study Status, Contacts/Locations v36
Study sites112 entries, revised
St.Saint Jude Children's Research Hospital
2020-05-06
Study Status, Contacts/Locations v35
Study sitesdetails revised at 2 of 112 sites
2020-04-09
Study Status, Contacts/Locations v34
Study sitesdetails revised at 1 of 112 sites
2020-03-04
Study Status, Contacts/Locations v33
Study sites106→112
2020-02-04
Study Status, Contacts/Locations v32
Study sitesdetails revised at 4 of 106 sites
2020-01-07
Study Status, Contacts/Locations v31
Study sites105→106
2019-11-19
Study Status, Contacts/Locations v30
Study sites104→105
2019-10-21
Study Status, Contacts/Locations v29
Study sites103→104
2019-09-18
Study Status, Contacts/Locations v28
Study sites103 entries, revised
Ascension Via Christi RegionalHospitals Medical CenterWichita Froedtert and the Medical College of Wisconsin
2019-08-02
Study Status, Contacts/Locations v27
Study sites100→103
2019-06-18
Study Status, Contacts/Locations v26
Study sites99→100
2019-05-14
Study Status, Contacts/Locations v25
Study sites95→99
2019-02-19
Study Status, Contacts/Locations v24
Study sites93→95
2019-01-22
Study Status, Contacts/Locations v23
Study sites69→93
2018-09-05
Study Status, Contacts/Locations v22
Study sites68→69
2018-08-06
Study Status, Contacts/Locations v21
Study sites66→68
2018-07-16
Study Status, Contacts/Locations v20
Study sites62→66
2018-06-08
Study Status, Contacts/Locations v19
Study sites61→62
2018-05-04
Study Status, Contacts/Locations v18
Study sitesdetails revised at 2 of 61 sites
2018-04-06
Study Status, Contacts/Locations v17
Study sites61 entries, revised
Memorial Sloan Kettering Monmouth Monmouth Memorial Sloan- Kettering Cancer Center
2018-03-06
Study Status, Contacts/Locations v16
Study sitesdetails revised at 1 of 61 sites
2018-02-05
Study Status, Contacts/Locations v15
Study sites44→61
This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.
Trial Details
NCT Number NCT02375204
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI), European Organisation for Research and Treatment of Cancer - EORTC, Movember Foundation, Institute of Cancer Research (ICR), United Kingdom, Cancer Research UK, UNICANCER, Irish Group CTI
Conditions Germ Cell Tumor, Teratoma, Choriocarcinoma, Germinoma, Mixed Germ Cell Tumor, Yolk Sac Tumor, Childhood Teratoma, Malignant Germ Cell Neoplasm +3 more
Enrollment 420 participants
Start Date 2015-08-06
Primary Completion 2031-06-01 (estimated)
Study Completion 2031-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-16