Trial · NCT00470366
Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors
NCT00470366, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2017-10-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors. Trials, record NCT00470366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00470366
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors
- NCT number
- NCT00470366
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell Tumor
- Interventions
- pegfilgrastim, cisplatin, ifosfamide, paclitaxel
- First posted
- 2007-05-07
- Last updated
- 2017-11-28
- Results first posted
- 2017-10-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Complete Response | 3 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions |
| Secondary | Progression-free Survival | Up to 8 years | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Percentage of Participants With Progression Free Survival | 3 years | Progression Free Survival at 3 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Number of Patients With Treatment Related Toxicity | 3 years | Toxicity evaluated and graded according to the National Cancer Institute, Version 3.0 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Complete Response | 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival | Up to 8 years | years | MEDIAN | |
| SECONDARY | Percentage of Participants With Progression Free Survival | 3 years | percentage of patients | NUMBER | |
| SECONDARY | Number of Patients With Treatment Related Toxicity | 3 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Complete Response | Paclitaxel, Ifosfamide, and Cisplatin | Complete Response | 38 | Participants | |
| Rate of Complete Response | Paclitaxel, Ifosfamide, and Cisplatin | PR-Negative | 7 | Participants | |
| Rate of Complete Response | Paclitaxel, Ifosfamide, and Cisplatin | Incomplete Response | 11 | Participants | |
| Progression-free Survival | Paclitaxel, Ifosfamide, and Cisplatin | 4.4 | Full Range 1 to 7.6 | years | |
| Percentage of Participants With Progression Free Survival | Paclitaxel, Ifosfamide, and Cisplatin | 72 | 95% Confidence Interval 61 to 84 | percentage of patients | |
| Number of Patients With Treatment Related Toxicity | Paclitaxel, Ifosfamide, and Cisplatin | 60 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paclitaxel, Ifosfamide, and Cisplatin | 60 | |
| Overall Study | COMPLETED | Paclitaxel, Ifosfamide, and Cisplatin | 56 | |
| Overall Study | NOT COMPLETED | Paclitaxel, Ifosfamide, and Cisplatin | 4 |
Source ClinicalTrials.gov
Adverse events73
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Paclitaxel, Ifosfamide, and Cisplatin | 19 | 60 | |
| other | Fatigue | General disorders | Paclitaxel, Ifosfamide, and Cisplatin | 17 | 60 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Paclitaxel, Ifosfamide, and Cisplatin | 15 | 60 | |
| other | Leukocytes | Investigations | Paclitaxel, Ifosfamide, and Cisplatin | 13 | 60 | |
| other | Neutrophils/granulocytes | Investigations | Paclitaxel, Ifosfamide, and Cisplatin | 13 | 60 | |
| other | Platelets | Investigations | Paclitaxel, Ifosfamide, and Cisplatin | 13 | 60 | |
| other | ALT | Investigations | Paclitaxel, Ifosfamide, and Cisplatin | 11 | 60 | |
| other | Neuropathy: sensory | Nervous system disorders | Paclitaxel, Ifosfamide, and Cisplatin | 11 | 60 | |
| other | Hyponatremia | Metabolism and nutrition disorders | Paclitaxel, Ifosfamide, and Cisplatin | 11 | 60 | |
| other | Hyperglycemia | Metabolism and nutrition disorders | Paclitaxel, Ifosfamide, and Cisplatin | 10 | 60 |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paclitaxel, Ifosfamide, and Cisplatin | 5 | 60 |
| Total, other adverse events | Paclitaxel, Ifosfamide, and Cisplatin | 60 | 60 |
| Total, serious adverse events | Paclitaxel, Ifosfamide, and Cisplatin | 34 | 60 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00470366
GET https://conductscience.org/api/trials/v1/NCT00470366/events?page=2