Trial · NCT00573131
Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer
NCT00573131, Phase 2, Terminated, Boston Scientific Corporation; results first posted 2014-05-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer. Trials, record NCT00573131. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00573131
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer
- NCT number
- NCT00573131
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 137 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Esophageal Cancer, Adenocarcinoma of the Esophagus, Squamous Cell Carcinoma
- Interventions
- OncoGel (Paclitaxel gel), cisplatin, 5-FU, radiation therapy, esophageal resection
- First posted
- 2007-12-13
- Last updated
- 2022-06-22
- Results first posted
- 2014-05-16
- Limitations and caveats
- Study prematurely terminated due to lack of efficacy in primary endpoint.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT | Screening and Week 12 | Per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and by Spiral CT assessment: Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is a \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
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 Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT | Screening and Week 12 | Subjects who received at least one treatment with OncoGel, systemic chemotherapy or external beam radiation therapy were included for analysis of efficacy. | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT | Group 1 | 12.5 | percentage of patients | ||
| Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT | Group 2 | 20.0 | percentage of patients |
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 1 | 72 | |
| Overall Study | STARTED | Group 2 | 65 | |
| Overall Study | COMPLETED | Group 1 | 62 | |
| Overall Study | COMPLETED | Group 2 | 57 | |
| Overall Study | NOT COMPLETED | Group 1 | 10 | |
| Overall Study | NOT COMPLETED | Group 2 | 8 |
Source ClinicalTrials.gov
Adverse events172
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 | Anaemia | Blood and lymphatic system disorders | Group 1 | 6 | 72 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 2 | 7 | 65 | |
| other | Leukopenia | Blood and lymphatic system disorders | Group 1 | 17 | 72 | |
| other | Leukopenia | Blood and lymphatic system disorders | Group 2 | 8 | 65 | |
| other | Neutropenia | Blood and lymphatic system disorders | Group 1 | 6 | 72 | |
| other | Neutropenia | Blood and lymphatic system disorders | Group 2 | 9 | 65 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Group 1 | 12 | 72 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Group 2 | 8 | 65 | |
| other | Abdominal pain | Gastrointestinal disorders | Group 1 | 8 | 72 | |
| other | Abdominal pain | Gastrointestinal disorders | Group 2 | 5 | 65 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 | ||
| Total, all-cause mortality | Group 2 | ||
| Total, other adverse events | Group 1 | 67 | 72 |
| Total, other adverse events | Group 2 | 55 | 65 |
| Total, serious adverse events | Group 1 | 30 | 72 |
| Total, serious adverse events | Group 2 | 20 | 65 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27890801 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Group 1 vs Group 2: 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/NCT00573131
GET https://conductscience.org/api/trials/v1/NCT00573131/events?page=2