Trial · NCT00002558
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
NCT00002558, Phase 1, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2016-05-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors. Trials, record NCT00002558. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00002558
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
- NCT number
- NCT00002558
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 108 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor
- Interventions
- filgrastim, carboplatin, etoposide, ifosfamide, paclitaxel, peripheral blood stem cell transplantation
- First posted
- 2003-01-27
- Last updated
- 2016-05-23
- Results first posted
- 2016-05-23
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Objective Response | 2 years | Overall Objective Response will be assessed prior to dose-intensive therapy and at the completion of therapy. Complete disappearance of all clinical, radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy). Patients must be free of disease for a minimum of 4 weeks. Partial Response: Complete disappearance of all biochemical evidence of disease in patients without a surgical procedure for a residual radiographic mass. Patients must demonstrate no biochemical recurrence or progression of radiographic masses for a minimum of four weeks (PR to chemotherapy} |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Objective Response | 2 years | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Overall Objective Response | Group A | Complete Response (CR) | 50 | participants | |
| Overall Objective Response | Group B | Complete Response (CR) | 4 | participants | |
| Overall Objective Response | Group A | Incomplete Response (IR) | 36 | participants | |
| Overall Objective Response | Group B | Incomplete Response (IR) | 8 | participants | |
| Overall Objective Response | Group A | Partial Response (PR) | 5 | participants | |
| Overall Objective Response | Group B | Partial Response (PR) | 3 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A | 92 | |
| Overall Study | STARTED | Group B | 16 | |
| Overall Study | COMPLETED | Group A | 92 | |
| Overall Study | COMPLETED | Group B | 15 | |
| Overall Study | NOT COMPLETED | Group A | 0 | |
| Overall Study | NOT COMPLETED | Group B | 1 |
Source ClinicalTrials.gov
Adverse events110
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 | Abdominal pain/cramping | Gastrointestinal disorders | Group A: <= 6 Cycles of Cisplatin | 8 | 92 | 8 |
| other | Abdominal pain/cramping | Gastrointestinal disorders | Group: B > 6 Cycles of Cisplatin | 0 | 16 | 0 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Group A: <= 6 Cycles of Cisplatin | 16 | 92 | 16 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Group: B > 6 Cycles of Cisplatin | 3 | 16 | 3 |
| other | Alopecia | General disorders | Group A: <= 6 Cycles of Cisplatin | 0 | 92 | 0 |
| other | Alopecia | General disorders | Group: B > 6 Cycles of Cisplatin | 1 | 16 | 1 |
| other | Bilirubin | Metabolism and nutrition disorders | Group A: <= 6 Cycles of Cisplatin | 23 | 92 | 23 |
| other | Bilirubin | Metabolism and nutrition disorders | Group: B > 6 Cycles of Cisplatin | 4 | 16 | 4 |
| other | Catheter-related infection | Infections and infestations | Group A: <= 6 Cycles of Cisplatin | 6 | 92 | 6 |
| other | Catheter-related infection | Infections and infestations | Group: B > 6 Cycles of Cisplatin | 3 | 16 | 3 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A: <= 6 Cycles of Cisplatin | ||
| Total, all-cause mortality | Group: B > 6 Cycles of Cisplatin | ||
| Total, other adverse events | Group A: <= 6 Cycles of Cisplatin | 92 | 92 |
| Total, other adverse events | Group: B > 6 Cycles of Cisplatin | 15 | 16 |
| Total, serious adverse events | Group A: <= 6 Cycles of Cisplatin | 7 | 92 |
| Total, serious adverse events | Group: B > 6 Cycles of Cisplatin | 2 | 16 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA008748 | Cancer Center Support Grant | Rudin, Charles M. | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Group A: <= 6 Cycles of Cisplatin vs Group: B > 6 Cycles of Cisplatin: serious adverse events |
Source Trial comparisons
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/NCT00002558
GET https://conductscience.org/api/trials/v1/NCT00002558/events?page=2