Trial · NCT01183559
A Trial of ZD6474, Paclitaxel, Carboplatin, 5-Fluorouracil, and Radiation Therapy Followed by Surgery
NCT01183559, Phase 1, Completed, Fox Chase Cancer Center; results first posted 2021-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of ZD6474, Paclitaxel, Carboplatin, 5-Fluorouracil, and Radiation Therapy Followed by Surgery. Trials, record NCT01183559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01183559
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of ZD6474, Paclitaxel, Carboplatin, 5-Fluorouracil, and Radiation Therapy Followed by Surgery
- NCT number
- NCT01183559
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 9 participants, actual
- Lead sponsor
- Fox Chase Cancer Center
- Conditions
- Cancer of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Cancer of the Stomach
- Interventions
- Vandetanib, 5 Fluorouracil (FU), Carboplatin, Paclitaxel, External Beam Radiation Therapy (RT)
- First posted
- 2010-08-17
- Last updated
- 2021-01-22
- Results first posted
- 2021-01-22
- Limitations and caveats
- Study closed due to reaching the stated endpoint of determination of the phase II recommended and tolerated dose of Vandetanib
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose of Vandetanib | Within 4 weeks of initiation of chemo/radiation therapy | To determine the maximum tolerated dose (MTD) of Vandetanib given concurrently with chemotherapy and radiation therapy followed by surgery (esophagectomy)evaluated by the frequency, severity and duration of adverse events that occur during treatment and for four weeks following surgery as measured by serial blood tests, electrocardiograms and physical assessments |
| Secondary | The Number of Participants With Adverse Events | Within 4 weeks of initiation of chemo/radiation therapy | To determine the safety and tolerability of Vandetanib when given in combination with chemotherapy and radiation therapy as evaluated by serial blood tests, electrocardiograms, and physical assessments during therapy and for four weeks following surgery |
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 | Maximum Tolerated Dose of Vandetanib | Within 4 weeks of initiation of chemo/radiation therapy | milligrams | NUMBER | |
| SECONDARY | The Number of Participants With Adverse Events | Within 4 weeks of initiation of chemo/radiation therapy | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Maximum Tolerated Dose of Vandetanib | Vandetanib | 100 | milligrams | ||
| The Number of Participants With Adverse Events | Vandetanib | 2 | 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 | Vandetanib | 9 | |
| Overall Study | COMPLETED | Vandetanib | 9 | |
| Overall Study | NOT COMPLETED | Vandetanib | 0 |
Source ClinicalTrials.gov
Adverse events12
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 | Anorexia | Gastrointestinal disorders | Vandetanib | 1 | 9 | 1 |
| other | ALT-SGPT | Investigations | Vandetanib | 1 | 9 | 1 |
| other | AST-SGPT | Investigations | Vandetanib | 1 | 9 | 1 |
| other | Leukocyte, total WBC | Investigations | Vandetanib | 2 | 9 | 2 |
| other | Mood alteration, Depression | Psychiatric disorders | Vandetanib | 1 | 9 | 1 |
| other | Neutrophills, ANC/AGC | Investigations | Vandetanib | 1 | 9 | 1 |
| other | Pain, upper abdomen | Gastrointestinal disorders | Vandetanib | 1 | 9 | 1 |
| other | Sodium, serum low (hyponatremia) | Investigations | Vandetanib | 1 | 9 | 1 |
| other | Syncope | Nervous system disorders | Vandetanib | 1 | 9 | 1 |
| other | Mucositis | Gastrointestinal disorders | Vandetanib | 1 | 9 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vandetanib | ||
| Total, other adverse events | Vandetanib | 9 | 9 |
| Total, serious adverse events | Vandetanib | 1 | 9 |
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/NCT01183559
GET https://conductscience.org/api/trials/v1/NCT01183559/registered