Trial · NCT00936936
High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors
NCT00936936, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2024-08-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors. Trials, record NCT00936936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00936936
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors
- NCT number
- NCT00936936
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Testicular Cancer
- Interventions
- Gemcitabine, Docetaxel, Melphalan, Carboplatin, Mesna, Ifosfamide, Etoposide, Stem Cell Transplant
- First posted
- 2009-07-10
- Last updated
- 2024-08-26
- Results first posted
- 2024-08-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With 2-year Event-Free Survival (EFS) | 2 Years | Event-free survival estimated from the first day of High-Dose Course Cycle #1 (Day -6) until tumor progression, relapse, or death from any cause. |
| Secondary | Overall Survival | 1 year post treatment | Number of Participants alive and disease free 1 year post treatment completion. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With 2-year Event-Free Survival (EFS) | 2 Years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | 1 year post treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With 2-year Event-Free Survival (EFS) | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 28 | Participants | ||
| Number of Participants With 2-year Event-Free Survival (EFS) | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 11 | Participants | ||
| Overall Survival | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 25 | Participants | ||
| Overall Survival | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 9 | Participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 41 | |
| Overall Study | STARTED | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 23 | |
| Overall Study | Cycle 1 | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 41 | |
| Overall Study | Cycle 1 | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 23 | |
| Overall Study | Cycle 2 | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 29 | |
| Overall Study | Cycle 2 | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 23 | |
| Overall Study | COMPLETED | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 29 | |
| Overall Study | COMPLETED | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 19 | |
| Overall Study | NOT COMPLETED | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 12 | |
| Overall Study | NOT COMPLETED | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 4 |
Source ClinicalTrials.gov
Adverse events138
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 | ALK increased | Investigations | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 4 | 41 | 4 |
| other | ALK increased | Investigations | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 3 | 23 | 3 |
| other | Allergic reaction | Immune system disorders | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 1 | 41 | 1 |
| other | Allergic reaction | Immune system disorders | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 0 | 23 | 0 |
| other | ALT increased | Investigations | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 41 | 41 | 70 |
| other | ALT increased | Investigations | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 22 | 23 | 22 |
| other | AST increased | Investigations | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 6 | 41 | 6 |
| other | AST increased | Investigations | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 2 | 23 | 2 |
| other | Bacterial | Infections and infestations | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 37 | 41 | 37 |
| other | Bacterial | Infections and infestations | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 14 | 23 | 14 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 22 | 41 |
| Total, all-cause mortality | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 12 | 23 |
| Total, other adverse events | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 41 | 41 |
| Total, other adverse events | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 23 | 23 |
| Total, serious adverse events | Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 7 | 41 |
| Total, serious adverse events | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 2 | 23 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26199392 | DERIVED |
Source PubMed
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT vs Cohort 2: HD GeM-DMC+ ICE for Refractory GCT: Number of Participants With 2-year Event-Free Survival (EFS) | Trial comparisons |
| Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT vs Cohort 2: HD GeM-DMC+ ICE for Refractory GCT: deaths from any cause | Trial comparisons |
| Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT vs Cohort 2: HD GeM-DMC+ ICE for Refractory GCT: Overall Survival | Trial comparisons |
| Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT vs Cohort 2: HD GeM-DMC+ ICE for Refractory GCT: serious adverse events | 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/NCT00936936
GET https://conductscience.org/api/trials/v1/NCT00936936/events?page=2