Trial · NCT00393861
Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients
NCT00393861, Phase 2, Completed, Indiana University; results first posted 2015-01-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients. Trials, record NCT00393861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00393861
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients
- NCT number
- NCT00393861
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Neoplasms, Germ Cell and Embryonal
- Interventions
- Bevacizumab and Oxaliplatin
- First posted
- 2006-10-30
- Last updated
- 2016-03-24
- Results first posted
- 2015-01-29
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Twelve Month Disease-free Survival Rate | 12 month post completion of treatment | The percent of patients being disease-free at 12 months after treatment initiation will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug. |
| Secondary | Objective Response Rate (Complete and Partial Response) | completion of study, up to 5 years | The percent of patients having an objective response (complete or partial response) will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug 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; Overall Response (OR) = CR + PR. |
| Secondary | Duration of Remission (CR + PR) | completion of study, up to 5 years | Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis. |
| Secondary | Overall Survival | completion of study, up to 5 years | Will be examined using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis. |
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 | Twelve Month Disease-free Survival Rate | 12 month post completion of treatment | All patients enrolled and received treatment. | percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (Complete and Partial Response) | completion of study, up to 5 years | All patients enrolled and received treatment. | percentage of participants | NUMBER |
| SECONDARY | Duration of Remission (CR + PR) | completion of study, up to 5 years | All patients enrolled and received treatment. | months | MEDIAN |
| SECONDARY | Overall Survival | completion of study, up to 5 years | All patients enrolled and received treatment. | months | MEDIAN |
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 |
|---|---|---|---|---|---|
| Twelve Month Disease-free Survival Rate | Oxaliplatin & Bevacizumab | 3.5 | 90% Confidence Interval 0.2 to 15.3 | percentage of participants | |
| Objective Response Rate (Complete and Partial Response) | Oxaliplatin & Bevacizumab | 27.6 | 90% Confidence Interval 14.5 to 44.3 | percentage of participants | |
| Duration of Remission (CR + PR) | Oxaliplatin & Bevacizumab | 4.7 | 95% Confidence Interval 2.1 to 17.2 | months | |
| Overall Survival | Oxaliplatin & Bevacizumab | 7.7 | 95% Confidence Interval 5.4 to 13.4 | months |
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 | Oxaliplatin & Bevacizumab | 29 | |
| Overall Study | COMPLETED | Oxaliplatin & Bevacizumab | 3 | |
| Overall Study | NOT COMPLETED | Oxaliplatin & Bevacizumab | 26 |
Source ClinicalTrials.gov
Adverse events21
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 | CONSTIPATION | Gastrointestinal disorders | Oxaliplatin & Bevacizumab | 4 | 29 | |
| other | HEARTBURN/DYSPEPSIA | Gastrointestinal disorders | Oxaliplatin & Bevacizumab | 3 | 29 | |
| other | NAUSEA | Gastrointestinal disorders | Oxaliplatin & Bevacizumab | 12 | 29 | |
| other | TASTE ALTERATION (DYSGEUSIA) | Gastrointestinal disorders | Oxaliplatin & Bevacizumab | 4 | 29 | |
| other | VOMITING | Gastrointestinal disorders | Oxaliplatin & Bevacizumab | 7 | 29 | |
| other | FATIGUE (ASTHENIA, LETHARGY, MALAISE) | General disorders | Oxaliplatin & Bevacizumab | 10 | 29 | |
| other | FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | General disorders | Oxaliplatin & Bevacizumab | 2 | 29 | |
| other | INJECTION SITE REACTION/EXTRAVASATION CHANGES | General disorders | Oxaliplatin & Bevacizumab | 2 | 29 | |
| other | PAIN - OTHER | General disorders | Oxaliplatin & Bevacizumab | 4 | 29 | |
| other | HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE | Respiratory, thoracic and mediastinal disorders | Oxaliplatin & Bevacizumab | 2 | 29 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxaliplatin & Bevacizumab | ||
| Total, other adverse events | Oxaliplatin & Bevacizumab | 15 | 29 |
| Total, serious adverse events | Oxaliplatin & Bevacizumab | 0 | 29 |
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/NCT00393861
GET https://conductscience.org/api/trials/v1/NCT00393861/events?page=2